Build vs. Buy vs. Partner in Life Sciences: Making the Right Call

February 27th, 2025 by

When should a life sciences organization build technology in-house? When is it smarter to buy off-the-shelf? And when does a strategic partnership make the most sense? These are the questions Derk Arts (CEO, Castor) and Nick Darwall Smith tackled in a candid LinkedIn Live discussion, breaking down the real costs, risks, and trade-offs of each approach.

The Core Considerations

Many organizations have faced the painful consequences of making the wrong build vs. buy decision—whether it’s an in-house project that spirals into a money pit, or an off-the-shelf solution that never quite delivers.

“One of the big pitfalls with internal development is not taking the full scope into consideration. What starts as a simple solution can become a long-term maintenance burden.” – Nick Darwall Smith

So how do you make the right call? The discussion highlighted eight critical factors:

  1. Uniqueness – Does this technology provide a true competitive advantage? If your solution gives you an edge that can’t be replicated, building might make sense. But if you’re reinventing the wheel, why not leverage existing solutions?
  2. Understanding of Requirements – If requirements are unclear or frequently changing, internal builds risk becoming endless development projects with scope creep.
  3. Complexity – The more complex the system, the more it demands ongoing maintenance, integrations, and updates—costs that are often underestimated.
  4. Time – Can you afford the internal build timeline? Delays could mean missing key opportunities or regulatory shifts that make your work obsolete before launch.
  5. Cost – Beyond licensing vs. FTEs, consider total cost of ownership—ongoing support, security, and compliance are often bigger expenses than the initial build.
  6. Support – Can your internal teams sustainably manage this technology? Vendors have dedicated support teams—does your org?
  7. Resources – Do you have the right talent in-house? If not, will gaps create bottlenecks?
  8. Infrastructure – Security, scalability, and compliance add significant burdens. Who owns the risk?

 

“It’s easy to underestimate the costs of maintaining a system. The first version is never the final version—business needs shift, and suddenly you’re dedicating an entire team just to keeping the lights on.” – Derk Arts

Spotting Red Flags

Both speakers emphasized the importance of recognizing warning signs early to prevent costly missteps:

“The best vendors are the ones that ask tough questions—because they understand what’s truly required.” – Nick Darwall Smith

Making the Right Call

A strategic approach is crucial. In many cases, buying or partnering is the smarter, lower-risk option. But there are exceptions—such as when proprietary data or highly unique business processes demand internal control.

Nick shared a cautionary tale about an in-house project that ran three times over budget due to underestimated maintenance needs. The team assumed developers could support the system post-launch, but that assumption led to constant disruptions and ultimately required a full rebuild.

Another common mistake? Not factoring in industry evolution. Some solutions—like regulatory information management systems—require frequent updates to stay compliant. If you can’t keep pace, a vendor with dedicated regulatory teams may be the better option.

“What works today might not work tomorrow. The best decisions are the ones that leave room for future flexibility.” – Derk Arts

The Role of AI in Build vs. Buy

AI is reshaping the traditional build vs. buy framework, but common pitfalls remain:

Final Takeaways

✅ If it’s not a differentiator, don’t build it – Owning technology that offers no strategic advantage is a waste of resources.

✅ Account for full lifecycle costs – The initial build is just the beginning—long-term maintenance often costs far more.

✅ Vet vendors aggressively – Look beyond sales pitches. Ask about reference customers, real-world performance, and support capabilities.

✅ AI adds complexity – If integrating AI, ensure your team has the expertise to manage it effectively.

For the full range of insights—including real-world case studies and practical advice on navigating build vs. buy vs. partner decisions—watch the complete discussion.

📺 Watch the full LinkedIn Live session here

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Do CROs Need to Reinvent Themselves in 2025? A Deep Dive with Greg Licholai and Derk Arts

February 26th, 2025 by

Contract Research Organizations (CROs) sit at a pivotal moment in their evolution. Economic constraints, regulatory shifts, and technological advancements are forcing them to rethink their value proposition. On a recent LinkedIn Live, Greg Licholai, Chief Medical and Innovation Officer at ICON, and Derk Arts, CEO of Castor, tackled a pressing question: Do CROs need to reinvent themselves in 2025?

The Macroeconomic and Regulatory Pressures Shaping CROs

The conversation kicked off with a broad look at the forces reshaping drug development. Pharma companies are feeling the pressure—rising R&D costs, shifting reimbursement structures, and increasing competition mean that every dollar spent on clinical trials must count. 

“There’s a lot happening at a macro level globally,” Arts noted. “The ability of society to reimburse ever-expanding and expensive healthcare is under scrutiny.”

Licholai echoed this sentiment, emphasizing how financial and regulatory pressures, such as the Inflation Reduction Act, are influencing drug development. “Pricing for drugs is shifting, and that directly impacts the therapeutic areas that get investment,” he explained. 

A key takeaway? The current system isn’t just going through another cyclical adjustment—it may be facing a more systemic transformation. CROs must anticipate these shifts and rethink their positioning within the industry.

FSP vs. FSO: The Never-Ending Debate

One of the most debated topics in CRO strategy is the pendulum swing between Functional Service Provision (FSP) and Full-Service Outsourcing (FSO). 

“This shift is cyclical,” Arts observed. “At any given time, we see pharma centralizing or decentralizing control over clinical trials. It’s driven by leadership changes, economic factors, and perceived control over costs.”

Licholai agreed but highlighted that the economics of outsourcing models are largely a wash. “If you go to the extremes—zero outsourcing or 100% outsourcing—the costs are pretty much the same. The real reasons to outsource are about efficiency, scalability, and expertise.”

In other words, there’s no silver bullet. Whether CROs succeed under an FSP or FSO model depends more on execution than on the model itself. 

The Rise of Site Networks and RWE

The industry is also witnessing the rapid consolidation of clinical trial sites. Large site networks are streamlining operations, making patient recruitment and data collection more efficient. But does this pose a threat to CROs?

“Well-run site networks can be a tremendous asset,” Licholai noted. “The real challenge in clinical research is patient recruitment. Anything that helps investigators conduct trials more efficiently is a net positive.”

At the same time, real-world evidence (RWE) is gaining traction. With smaller Phase 2/3 trials and larger real-world studies post-approval, RWE could change the fundamental structure of clinical trials. 

“We’re seeing a shift where real-world trials could be incorporated earlier,” Arts suggested. “This could make trials cheaper and allow for more diverse patient populations.”

However, both agreed that regulatory bodies remain cautious. “The concern is that adding real-world data too early could slow down approvals due to increased variability,” Licholai pointed out. “But as RWE becomes more accepted, it could significantly reduce the cost of drug development.”

The AI Factor: Hype or Reality for CROs?

AI is one of the most talked-about trends in clinical trials, but what does it really mean for CROs? 

“I’m a huge believer in AI, but also a realist,” Arts stated. “Right now, we’re in the early phases. The FDA’s guidance only covers model development, not practical applications in clinical trials.”

Licholai expanded on this, suggesting that AI’s most immediate impact will be in automating routine tasks, such as medical writing, site selection, and patient matching. However, the idea of AI-driven Clinical Research Associates (CRAs) remains a distant prospect. 

“The workloads in clinical operations are enormous,” Arts pointed out. “Burnout among site coordinators and CRAs is high. If AI can help with monitoring and compliance, that’s where the industry could see real benefits.”

Another major question is data ownership. As AI models require vast datasets to be effective, sponsors may want more control over the metadata generated by CROs. 

“This ties back to the FSP vs. FSO debate,” Arts noted. “If sponsors want deeper insights from AI, they might push for more control over data collection and analysis.”

The Road Ahead for CROs

So, do CROs need to reinvent themselves? The consensus is that evolution—not revolution—is the path forward. 

“The fundamentals of clinical research aren’t changing overnight,” Licholai said. “But CROs that embrace technology, build stronger site partnerships, and adapt to new trial models will be in the best position.”

Arts agreed, but with a note of caution: “CROs can’t afford to be complacent. The biggest risk is sticking too rigidly to legacy processes while the industry moves on.”

Ultimately, the discussion made it clear that the future of CROs depends on their ability to be proactive rather than reactive. Whether through site network partnerships, AI adoption, or new outsourcing models, those who take strategic risks will be the ones defining clinical research in 2025 and beyond.

Did you miss the live conversation? Watch the full conversation on LinkedIn Live. What do you think—are CROs evolving fast enough, or do they need a complete reinvention?

Share your thoughts in the comments on LinkedIn.

 

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Clinical Trials Aren’t Just About Patients (and That’s Okay)

January 16th, 2025 by

What if “patient-centricity” in clinical trials is more about perception than reality?

On January 9th, 2025, Derk Arts (CEO of Castor) and Brad Hightower (CEO of Hightower Clinical) explored this idea during a LinkedIn Live discussion, addressing a recent hotly debated topic on LinkedIn: balancing patient-centricity with scientific rigor. The discussion examined whether prioritizing patient experience risks undermining the core purpose of clinical trials and offered practical insights into designing ethical, effective, and efficient research protocols.

If you missed the live conversation, the full discussion is available for replay—offering unfiltered perspectives on one of the industry’s most pressing challenges.

Clinical Trials: Protocol-Centric by Design

The conversation began with a direct assertion: clinical trials are about the protocol, not patient care. While patient-friendly practices can improve engagement and enrollment, Brad Hightower cautioned against framing trials as care options.

“We’re following a protocol. That’s what trials are for,” Brad explained. “We can make trials more accessible, but we can’t blur the line between research and treatment.”

This distinction is crucial. When trials are marketed as “patient-centric,” participants may develop a “therapeutic misconception”—believing they will personally benefit, even in placebo-controlled studies. Such misunderstandings risk eroding trust in clinical research and diminishing the informed consent process.

Burden Reduction: A Strategic Imperative

While trials shouldn’t be misrepresented as care, reducing the burden on patients and sites remains critical to their success. Derk Arts highlighted tools like eConsent as examples of solutions that simultaneously improve patient understanding and site efficiency.

“Informed consent isn’t a checkbox,” Derk noted. “It’s a process to ensure participants truly understand the commitment they’re making.”

Brad shared that patient-friendly protocols often attract higher enrollment and retention rates. For example, trials with manageable visit schedules and intuitive digital tools are easier for participants and more efficient for sites to implement.

Are We Overselling Patient-Centricity?

A recurring theme was whether the industry’s focus on “patient-centricity” has been taken too far? Both Derk and Brad expressed concerns about overpromising benefits to participants.

Brad shared a particularly stark example:

“I’ve seen patients in placebo-controlled trials who didn’t understand they might not receive treatment. One participant’s condition worsened severely because of this misconception. That’s not ethical.”

The takeaway? Trials should be accessible and transparent—but never misrepresented as direct care options.

The Problem with Overly Narrow Criteria

Eligibility criteria emerged as another key challenge. Brad explained how overly restrictive inclusion/exclusion criteria hinder enrollment, even in specialized clinics.

“If a migraine clinic sees 1,000 patients but none qualify for a migraine trial, the protocol is the problem,” Brad said.

Derk agreed, emphasizing that protocols designed for narrowly defined populations often fail to reflect real-world demographics. This disconnect not only delays enrollment but also limits the applicability of trial results.

Collaborating Through Platform Trials

One potential solution to these challenges is platform trials, which test multiple interventions under a shared protocol. Derk shared his experience working on adaptive platform trials during COVID-19, where this model reduced redundancy and allowed for more efficient data collection.

“Platform trials make it easier to compare interventions and reduce competition over limited patient populations,” Derk explained.

However, adoption remains slow due to the pharmaceutical industry’s preference for retaining control over trial design and outcomes.

Incremental Improvements, Not Silver Bullets

The session concluded with a reminder that clinical research is inherently complex. Both Derk and Brad emphasized the importance of focusing on small, meaningful improvements—rather than chasing industry buzzwords or quick fixes.

“There’s no magic solution,” Brad said. “This work is hard, and it should be. Our job is to make incremental progress while staying true to the scientific process.”

Derk echoed this sentiment:

“We can’t lose sight of the fundamentals—clear communication, streamlined processes, and respecting the protocol. That’s how we make trials ethical and effective.”

Key Takeaways

  1. Science First: Trials are about answering scientific questions, not delivering care.
  2. Transparency Matters: Clear communication reduces misconceptions and builds trust.
  3. Practical Design Wins: Reducing burden improves enrollment and retention while respecting scientific rigor.
  4. Collaborate for Efficiency: Platform trials offer a promising path to innovation.

Watch the Full Discussion

Missed the live conversation? You can watch the full replay of this insightful discussion between Derk and Brad on LinkedIn. Discover actionable strategies for improving trial design, debunking misconceptions, and navigating the challenges of modern clinical research.

Click here to watch the LinkedIn Live replay now.

This discussion underscores the need for a balanced approach to clinical trials—one that respects the protocol while prioritizing transparency and accessibility. By focusing on incremental progress and ethical practices, the industry can create a research ecosystem that benefits both science and society.

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A New Perspective on Clinical Research: Accessibility and Innovation

December 20th, 2024 by

In a recent LinkedIn Live, Joost Rigter shared his deeply inspiring journey and valuable insights into accessibility in daily life and clinical research. Hosted by Derk Arts, the session delved into the challenges of navigating complex content for individuals with visual impairments and highlighted actionable ways the industry can do better.

Joost’s Story: Turning Challenges into Opportunities

Joost is a motivational speaker and social entrepreneur from the Netherlands. As an introduction, he shared his story about his progressive eye disease, retinitis pigmentosa, which gradually reduced his vision to just 0.8%. Despite this, Joost emphasized his focus on adaptation and positivity:

“It became clear to me that I didn’t have to read with my eyes, but to hear and listen to information.”

From struggling as a child to see the blackboard to building a career inspiring thousands, Joost demonstrated that perspective can transform limitations into opportunities. He has started his own company and delivers motivational speeches to over 40,000 people annually, focusing on themes like acceptance, trust, and connection.

The Reality of Accessibility in Clinical Research

The conversation shifted to how Joost navigates complex content, such as government letters, bank statements, and legal documents. For him, technology like voiceover tools and seeing AI have been critical in bridging accessibility gaps:

“When I point my camera at a letter, it reads it sentence by sentence. But a 40-page document? That’s still very difficult.”

Derk introduced the topic of Informed Consent Forms (ICFs) used in clinical trials. These documents, often 40+ pages long, are designed to inform participants about the study. However, they are notoriously complex, even for those with full vision. Joost’s experience revealed an unsettling reality—he often trusts others to explain the document and signs without fully understanding it:

“I trust it, and I sign… but for something like clinical trials, that’s a lot of trust.”

Innovation Through AI: Making Complex Content Accessible

A key moment in the conversation was the discussion around AI-generated podcasts, which transform dense, text-heavy documents into engaging, conversational audio formats. For Joost, this innovation is a game-changer:

“I was so happy with it. It made the document easier to understand, and I could listen to it on my own time.”

Joost emphasized how this approach could benefit a broader audience beyond visually impaired individuals, including those with low literacy or difficulty understanding complex texts. The ability to repeat, pause, and digest information at one’s own pace ensures a more informed and empowered decision-making process.

The Future of Accessibility in Clinical Trials

The conversation underscored a clear need for the clinical trial industry to prioritize accessibility from the ground up. Some key takeaways included:

– Simplify documents to ensure readability.

– Leverage AI tools to provide audio and conversational versions of critical information.

– Focus on human interaction—participants benefit from clear, verbal explanations from trusted professionals.

“We need to think of accessibility first, not as an afterthought,” Joost concluded.

Final Thoughts

Joost’s story is a testament to resilience and innovation. His journey reminds us that accessibility is not just about tools—it’s about creating systems that empower everyone. The clinical trial industry has an ethical responsibility to ensure that all participants, regardless of their abilities, can fully understand what they are consenting to.

As Joost aptly put it:

“It’s about looking at changes differently and finding ways to adapt. AI is helping me, and it will help so many others too.”

This webinar served as both a wake-up call and a vision for the future: one where technology bridges gaps, accessibility is the norm, and everyone has a fair opportunity to engage with critical information.

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What do we measure with PROs in head and neck cancer? Pain, QoL, adverse events and more

December 30th, 2024 by

Redefining Outcomes in Oncology with PROs

Patient-Reported Outcomes (PROs) have become essential in oncology research, bridging the gap between clinical efficacy and patient experience. By prioritizing the patient’s voice, PROs capture the nuanced impacts of treatment, shaping interventions that improve care quality and overall outcomes (Kluetz et al., 2016). Recent studies, such as White et al. (2024), underscore the unique emotional distress experienced by head and neck cancer patients. Traditional clinical outcomes often overlook these dimensions, which can be effectively captured through PROs. This is why oncology Randomized Controlled Trials (RCTs) have gradually moved from non-PRO reporting to a greater focus on PROs (Gode and Faggion, 2024).

In head and neck cancer, where treatments significantly affect physical and psychosocial aspects, PROs provide critical insights into patients’ symptoms, functional impairments, and overall quality of life (QoL). This article explores how PROs enhance research in this area, delves into measurement tools, examines the rise of electronic PROs (ePROs), and addresses challenges in integrating PROs into clinical trials.

The Role of PROs in Head and Neck Cancer Research

Capturing Patient-Centered Data

Treatments for head and neck cancer often impair speech, swallowing, and physical appearance, profoundly affecting patients’ psychosocial well-being. PROs address this gap by capturing direct patient-reported data on symptoms, adverse events, and functional impairments (Strong, 2015). These insights are critical for developing personalized treatments that balance efficacy, tolerability, and patient well-being (Basch et al., 2016).

Rehabilitation efforts further amplify the role of PROs. For instance, Matko et al. (2024) demonstrated significant improvements in QoL and reductions in psychological distress among head and neck cancer patients undergoing rehabilitation programs. Such findings underscore the value of PROs in tailoring interventions to meet patient-specific needs.

Transforming Study Designs and Clinical Practice

The inclusion of PROs in clinical trials drives innovation in study design. Trials can evaluate therapies holistically by incorporating metrics like pain, fatigue, and social functioning. For example, Win et al. (2025) emphasized how ePROs support real-time symptom tracking, enabling better management of acute and chronic toxicities. These innovations facilitate shared decision-making and improve treatment guidelines.

Instruments for Measuring PROs in Head and Neck Cancer

Commonly Used Tools

Validated instruments tailored to specific aspects of the patient experience include:

Gonçalves et al. (2024) highlighted the importance of these tools in palliative care settings, demonstrating their effectiveness in capturing symptom distress and its impact on QoL. However, standardization is crucial to improve data comparability and facilitate meta-analyses (Strong, 2015).

The Rise of ePRO Platforms: Opportunities, Challenges & Implementation

In clinical trials, adopting electronic Patient-Reported Outcomes (ePROs) can transform how patient-reported data is collected, analyzed, and utilized. However, as with any innovation, ePROs come with advantages and challenges.

Benefits of ePROs

Digital platforms like Castor ePRO are revolutionizing PRO data collection and analysis. By leveraging devices like smartphones, ePROs:

Kiafi et al. (2024) provided comparative evidence that advanced therapies like proton radiation improve PROs. These benefits highlight ePROs’ potential for more effectively managing acute and chronic symptoms.

 

Challenges and Mitigation Strategies

Despite their benefits, ePROs present challenges:

 

Best Practices for Integrating ePROs in Clinical Trials

Successful implementation of ePRO requires addressing several practical considerations to ensure optimal usability, data quality, and patient engagement. With that in mind, researchers should consider the following strategies:

  1. Assess Digital Literacy Early: Evaluate patients’ tech skills and access, providing support as needed.
  2. Choose the Right Platform: Prioritize secure, user-friendly tools that integrate with EMRs.
  3. Simplify Interfaces: Pilot test tools to reduce barriers to data entry and improve usability.
  4. Leverage Real-Time Data: Use immediate feedback to enhance trial outcomes and patient care.

The Future of ePROs in Head and Neck Cancer Research

As ePROs evolve, AI and predictive analytics will take them further. Advanced platforms can:

For example, Gudenkauf et al. (2024) demonstrated how AI tools like the FACT-ICM-17 provide more precise symptom tracking, revolutionizing patient management.

Conclusion

The adoption of ePRO platforms is reshaping the landscape of head and neck cancer research. By improving data quality, increasing patient engagement, and enabling real-time analysis, ePROs offer unparalleled opportunities to capture the patient’s voice. However, addressing digital literacy, ensuring robust data security, and selecting reliable platforms remain critical to their success.

The future lies in integrating AI and advanced analytics into ePROs, pushing the boundaries of personalized care. By embracing these innovations, researchers and clinicians can transform oncology research, making patient-centered care not just a goal but a reality.


The goal is clear: Embrace innovation, amplify the patient voice, and transform outcomes.

 

References

  1. Basch, E., Deal, A.M., Kris, M.G., et al. (2016). Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. Journal of Clinical Oncology, 34(6), 557–565. DOI: 10.1200/JCO.2015.63.0830
  1. Delgado, D.A., Lambert, B.S., Boutris, N., et al. (2018). Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. JAAOS Global Research and Reviews, 2(3), e088. DOI: 10.5435/JAAOSGlobal-D-17-00088
  1. Gode, M., & Faggion, C.M. Jr. (2024). Review of patient-reported outcomes (PROs) and non-PROs in randomized controlled trials addressing head/neck cancers. Cancer Medicine, 13(8), e7036. DOI: 10.1002/cam4.7036
  1. Gudenkauf, L.M., Tometich, D.B., Hoogland, A.I., et al. (2024). Validation of the Functional Assessment of Cancer Therapy–Immune Checkpoint Modulator 17-Item Symptom Index (FACT-ICM-17) to Facilitate Implementation in Oncology. SSRN. Access PDF
  1. Kiafi, P., Chalkia, M., Kouri, M.A., et al. (2024). Photon vs. Proton Radiation Therapy in Head and Neck Cancer: A Review of Dosimetric Advantages and Patient Quality of Life. Journal of Cancer Research, OAE Publishing. Access Article
  1. Kluetz, P.G., et al. (2016). Patient-Reported Outcomes in Cancer Clinical Trials: Measuring Symptomatic Adverse Events With the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). American Society of Clinical Oncology Education Book, 36, 67–73. DOI: 10.1200/EDBK_159514
  1. Matko, Š., Knauseder, C., Riedl, D., et al. (2024). Effects on Quality of Life, Functional Disabilities, and Psychological Distress in Head and Neck Cancer Patients: Outcomes of Cancer Rehabilitation. Research Square. Access PDF
  1. Melzack, R. (1975). The McGill Pain Questionnaire: Major Properties and Scoring Methods. Pain, 1(3), 277–299. DOI: 10.1016/0304-3959(75)90044-5
  1. Strong, L.E. (2015). The Past, Present, and Future of Patient-Reported Outcomes in Oncology. American Society of Clinical Oncology Education Book, 35, e616–e620. DOI: 10.14694/EdBook_AM.2015.35.e616
  1. White, M.C., Corbett, C., Cannon, T.Y. (2024). Patient-Reported Distress in Individuals With Head and Neck Cancer. JAMA Otolaryngology. Access Article
  1. Win, T., Kharofa, J., Frankart, A.J. (2025). Evaluation of Clinical Trials Addressing Supportive Care Measures for Management of Acute and Chronic Radiation Toxicities. Supportive Care in Cancer. DOI: 10.1007/s00520-024-09070-5

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Developing an Infrastructure for Patient-Centric Decentralized Trials

August 11th, 2021 by

After airing the webinar Achieving Health Equity in Clinical Research during InformaConnect’s DCT Digital Week, Castor caught up with presenter Sam Eells, Co-founder and Chief Design Officer at Lightship, to discuss the infrastructure needs for providing the best patient experience and ensuring data integrity in decentralized clinical trials.

Lightship is a virtual-first provider focused on combining operational excellence and the best virtual tools in clinical trials. The company was set up by industry experts including Eells, who has 13 years of experience running clinical trials at Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute. Some of this research was conducted via decentralized methods, to help minimize familial transmission. This involved home visits conducted by traveling research coordinators. Through this work, Eells gained a great deal of experience in decentralized research and identified what was needed to enhance the patient experience and deliver more successful clinical trials.

Eells pointed out that Castor’s suite of eClinical solutions enables researchers to address some common issues in clinical trials. They provide a seamless experience for physicians, nurses, and study coordinators. Castor’s proven, globally compliant Clinical Data Management System (CDMS) for better trials enhances the speed and simplicity of building clinical studies, data integration, and real-time reporting.

Using decentralized and hybrid clinical trial solutions, study coordinators can save data instantly and accurately in the study database, without any further processing. Considering a patient’s needs and providing solutions, like mobile hotspots and preconfigured devices, Eells says, is fundamental for Lightship. 

Eells has long seen the benefits of working with patients in their homes in what is a very natural and effective way of conducting research. Decentralized clinical trials can substantially increase data quality by capturing a more representative view of the patient’s day-to-day experience in an environment where they are relaxed. It can also make data capture more predictable because the patient doesn’t have the challenge of scheduling site visits around other obligations. 

The ideal decentralized trial places a premium on patient experience, as this directly contributes to retention and likelihood of participation in future studies. Eells emphasizes the vital importance of building trust between patients and researchers. Lightship has designed additional training and simulations for its care team to undertake before each clinical trial, as part of making studies safer, more comfortable, and more convenient for the patient.  

At Lightship, Eells comments: “It’s really rewarding to be at the intersection of bringing life-enhancing and life-saving innovations to market. We have seen patients and healthcare companies embracing virtual models and today the vast majority of patients are now interested in telehealth. 

“We’re focused on improving access to clinical trials for a more diverse range of patients globally, and enhancing the process for clinicians as well as patients, to make every clinical trial better than the last.”

Wondering how to get started with your decentralized trial? Visit https://www.lightship.com/, and check out Castor’s suite of tools for decentralized and hybrid trials.

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What Is eConsent in Clinical Trials?

August 23rd, 2021 by

In short, eConsent is the electronic or digital version of informed consent—one of the first interactions that participants have with a study.

econsent electronic signature graphic

Therefore, eConsent must meet all the criteria of informed consent, simply removing the paper from the site and instead using a mobile device or computer to provide consent instead.

Remote eConsent represents a paradigm shift, where consent can be obtained remotely in the comfort of a participant’s home, local clinic, or anywhere else convenient. It allows participants to be screened, give consent, and enroll in clinical trials remotely without the burden of visiting a research site.

As eConsent platforms mature, exciting new interactive and visual features are being added to increase participant engagement and comprehension, such as:

However, even robust engagement materials are not meant to replace the important discussion between the participant and site staff. The clinical research site will continue to play a critical role in the consenting process.

Castor’s remote eConsent solution is a powerful platform that puts the participant at the center of the consent process and reduces the workload for site staff. Reach out to one of our friendly Castorians to find out how our remote eConsent solution can set up your next study for success.

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ProlaC Study: 2019-20 Castor Research Award Nominee #6

March 11th, 2020 by

When treating microprolactinomas (hormone-secreting tumors on the pituitary gland) is surgical treatment (endoscopic adenoma resection) superior and cost-effective when compared to medical treatment with a dopamine agonist? Our sixth Castor Research Award nominee ProlaC Study set out to study this question.

Research Overview

Almost half of all pituitary adenomas produce the hormone prolactin, and so are considered a prolactinoma. The production of prolactin by the prolactinoma leads to hyperprolactinemia, which brings about the typical symptoms caused by prolactinomas, that is, galactorrhoea, menstrual cycle irregularities, decreased fertility, and decreased libido.

Current guidelines describe dopamine agonists, for example, cabergoline, as first-line treatment for prolactinoma patients and surgical resection as second-line treatment in case of drug intolerance or resistance. Although dopamine agonist treatment is effective in decreasing the prolactin level (and thus the prolactinoma-related symptoms) in most patients, the majority of patients need prolonged treatment (two-year remission rates remain low). Up to 40% of patients experience side-effects.

In contrast, endoscopic trans-sphenoidal prolactinoma resection results in immediate remission in more than 80-90% of patients with a low rate of long-term morbidity from complications (< 3%). We hypothesize that early or upfront endoscopic trans-sphenoidal surgery in patients with a non-invasive prolactinoma of limited size will increase the health-related quality of life and remission rate. To date, no good-quality randomized clinical trials have been performed that compared dopamine agonist treatment to surgery on remission rate or health-related quality of life.

About the team

The study team is from the Leiden University Medical Centre, Departments of Neurosurgery and the Internal Medicine (Division of Endocrinology).  Team members include:

Study design and methodology

The study used the multicentre cohort multiple Randomized Clinical Trial design (cmRCT). In January 2018, we started a multicentre observational Cohort Study aimed to longitudinally document current standard care, medical outcomes of treatments (for example, remission rates and the rate of adverse effects), and health-related quality of life for all prolactinoma patients throughout the Netherlands.

The Prolac cohort study went live in April 2019. The multicentre Randomized Clinical Trials (RCT) which begin in June of 2019 consist of three individual but simultaneously running RCTs, all aimed to compare early or upfront endoscopic transsphenoidal surgery to standard care in patients with a non-invasive prolactinoma of limited size. Patients will be divided over the three RCTs based on the treatment they have already received before randomization:

  1.   Newly diagnosed patients who have not yet received prolactinoma treatment
  2.   Patients who have received short (4-6 months) pre-treatment with a dopamine agonist
  3.   Patients who have a persisting prolactinoma after long (> 2 years) pre-treatment with a dopamine agonist.

Stop losing study opportunities to poor data capture! Sign up for our webinar to learn how standardizing data for reuse opens up new research possibilities.

Research outcome

The main outcomes for the RCT are health-related quality of life after 12 months and remission rate after 36 months. Health-related quality of life is defined with the score on the Mental Health Scale of the MOS SF-36 12 months after randomization. Disease remission is defined as a normal prolactin level (according to the normal values of the laboratory where it is measured) in the absence of dopamine agonist treatment, 36 months after randomization.

Secondary outcomes of the RCT include cost-effectiveness, clinical and biochemical disease control, adverse effects of treatment, and disease bother measured with the Leiden Bother and Needs Questionnaire. The observational Cohort Study also assesses these outcomes of current standard care for all prolactinoma patients.

How Leiden University Medical Centre uses Castor

The team uses Castor EDC as an electronic Case Record Form and Data Management System, which is accessible from all study sites, for both the observational Cohort Study and the RCT. The team will randomize participants in the RCT using the Castor randomization tool. For both the Cohort Study and the RCT, the team uses Castor functionality to send and collect questionnaires electronically.

“In general, what I value about Castor, is the company mentality it breathes,” said Ingrid Zandbergeg.

“As a more experienced user, I feel my database and eCRF have benefitted and will continue to benefit from the expertise, enthusiasm, and availability of the Castor team. More importantly, the form exchange, webinars, and the user manual have helped me build my database and have inspired me to share my experiences with my colleagues and to share with the hospital data management department to create a forum for improving data management awareness and sharing experience between departments.”

“One of the most important features of Castor for our multicentre studies is its accessibility from the numerous different study sites with which we collaborate, which ultimately enforces the protection of participant privacy. It is valuable to us that by using Castor, we can control and monitor access to CRFs of a particular study site for each individual investigator. We especially value the shielded part of the CRF to store a participant’s email address for distributing questionnaires.”

Stay tuned on the Castor EDC blog for more 2019-2020 Castor Research Awards nominations. We wish the nominees good luck and smart science—and encourage all researchers to share their projects for the chance to win €3000!

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An Engineering Spotlight: What’s it like to ‘crunch the code’ at Castor?

April 30th, 2020 by

Bas is one of our Senior Software Engineers. Having recently joined our team of Castorians, I wondered how he’s been experiencing working as a Back-End Engineer at Castor? What does a “day-in-the-life” look like? How has his role been impacted by COVID, and why would he encourage other Engineers to join us on our purpose-driven mission?

Firstly, a little insight to what our Engineers use at Castor (yes, our stack is stacked!) 


Knowing what you know now, if you could look back to 8 months ago as you were applying to join Castor, what would you tell yourself?

I would tell myself not to worry about not having domain-specific knowledge. The field Castor operates in might seem daunting at first, but you’ll start learning the ropes on day one and never stop!

Coming into the role, what did your first 3 months look like as a Senior Software Engineer?

I was started off with a week of onboarding sessions in which I learned more about the company and its different departments. In between those sessions I got to know my team members and together with Volker (our awesome Engineering Manager) they got me set up with all the tools and access that I needed. 

Quickly thereafter, you’ll find yourself exploring the EDC codebase and working on your first ticket. Mine was a nice vertical slice in which I got to work on multiple layers of the application.

You’re part of the regular day-to-day much quicker than I had expected and that’s because of the great support you get!

How would you describe the culture and working style in Castor’s Engineering team?

Supportive is the first word that comes to mind. Everyone is always willing to help you out whenever needed. Be it pairing up to do some code ‘spelunking’, or giving background info on decisions that were made in the past. You’re immediately treated as an equal and your opinion matters right away, which made me feel at home within the first week.

What does Castor’s product release process look like? 

We have around 4 big releases per year and a smaller release every 2-3 weeks. A cycle is kicked off by determining what should be in it. After that a development cycle of about 2 months. Following that we do a feature freeze in which we only do fixes 

And, would you say there’s a good balance between new features and refactoring?

It varies but overall I would say, yes there is. We mainly apply the boy scout principle, leave things behind a little nicer than you found them, in the regular day-to-day. If a bigger refactor is needed to make it easier to fit in a new feature then it’s highly encouraged.  

Castor has been doing a lot to support researchers during the COVID crisis. Has this meant new opportunities or new initiatives for you and the Engineering team? 

Definitely, it was a bit hectic when we had a short-term shift in priorities. We had to expand our API on the EDC to support a mobile app that was developed over the span of two weeks. The app is meant to record COVID-19 symptoms in a healthy group of participants. The below infographic shows how Castor is working to support the fight against coronavirus!

That all sounds really exciting and truly purposeful. With all of this work, have you been given much support by Castor to keep working through the crisis?

Castor vs Covid-19

The support-system that is in place has been wonderful. People that lacked stuff at home to work comfortably got items delivered by our awesome People Team. Since most of us already worked from home one day a week, the transition has been quite smooth.

With all this in mind, why would you encourage other Engineers to come and join the team? 

If you want to be able to flex your ‘tech-muscle’ while working on something that will benefit a lot of people, within a company that is open, inclusive, and full of people that are passionate about what they do and how they do it, then you should come and join us!

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Bridging clinical efficacy and real-world effectiveness in digital therapeutics trials

January 25th, 2022 by

How real-world data capture closes the gap

No matter how conclusive clinical evidence is for medical treatments, developers may struggle to see precisely how their treatment performs in the real world—outside the controlled environment of the clinic or office. Do patients take the medication as expected while immersed in busy schedules? How often do they practice the exercises the therapist prescribes?

Unfortunately, medical treatments proven to work in clinical trials do not always measure up in the real world. According to Simon Makin’s “A smarter way to treat” article, one quarter to one half of the global population doesn’t take medications as recommended. In the U.S., this failure links to up to 125,000 deaths and costs up to $289 billion.1 The gap between efficacy and effectiveness is a significant issue impacting many.

Digital therapeutics provide real-world data capture

Enter digital therapeutics (DTx) and their unique ability to capture real-world data remotely. DTx are software-based, evidence-driven treatments for managing, preventing, and treating a wide range of medical conditions or illnesses.2 Unlike conventional medical interventions such as medications or medical devices, DTx can constantly gather data on patients’ involvement and progress—giving a crystal-clear view of how the treatment is working outside of a clinical setting.

bridging-clinical-efficacy-and-real-world-effectiveness-thumbnail

DTx capture data via software on patients’ devices or connected wearables. App data includes any biometrics recorded in the app, patient-reported outcomes, patient progress through software modules, and other data stored in the app, such as clinic visits and test results. While more traditional data collection methods are periodic, real-world data collection can be continuous and ongoing.3 When used effectively, the detail captured improves the data quality and helps demonstrate how users interact with the treatment in their everyday lives.4

These examples illustrate DTx real-world data capture:

Tech helps manage real-world data capture

Tech tools help DTx maximize the impact of the real-world data they capture. Technology can assist in every aspect of handling patient data—from collecting responses from digital patient surveys to capturing, processing, and integrating data from varied sources to securely tracking patients’ consent. Software developed specifically for DTx streamlines data capture and management, making it easier for DTx to get products to market and into patients’ hands. DTx real-world data capture can bridge the gap between how well researchers think their treatment functions (efficacy) and how well their treatment performs (effectiveness) outside of a clinical setting. Regular, remote data capture can transform how effective treatments can be and the type of people they can reach.

 

1Makin S. A smarter way to treat. Nature. 2019;573. https://media.nature.com/original/magazine-assets/d41586-019-02873-1/d41586-019-02873-1.pdf. Accessed August 27, 2021.
2Understanding DTx. Digital Therapeutics Alliance. https://dtxalliance.org/understanding-dtx. Accessed August 26, 2021.
3Sverdlov O, van Dam J, Hannesdottir K, and Thornton-Wells T. Digital therapeutics: An integral component of digital innovation in drug development. Clin Pharmacol Ther. 2018;104(1):72-80. doi:10.1002/cpt.1036
4Van Norman G. Decentralized clinical trials: The future of medical product development? JACC Basic Transl Sci. 2021;6(4):384–387. doi: 10.1016/j.jacbts.2021.01.011
5DTx product case study: Propeller. Digital Therapeutics Alliance. https://dtxalliance.org/products/propeller/. Accessed August 26, 2021.
6The Mabu care insights platform. Catalia Health. http://www.cataliahealth.com/platform-ai/. Accessed September 8, 2021.
7Patient-centered solutions. Catalia Health. http://www.cataliahealth.com/solutions/. Accessed September 8, 2021.
8How MyCite works. Abilify MyCite. https://www.abilifymycite.com/how-mycite-works. Accessed September 8, 2021.

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Three Ways Remote eConsent Improves Trial Efficiency

August 5th, 2021 by

Research participants want to feel like they’re more than just test subjects. Unfortunately, in the past, clinical research culture often left participants feeling research was performed on them rather than with them. Today’s researchers, therefore, need to gain trust, share information, and answer questions in order to recruit and retain trial participants. Fortunately, eConsent is offering new ways to do exactly that.

Remote eConsent goes far beyond ensuring the safety of both the participant and team members during a season of social distancing. It can also lower participant access barriers and democratize clinical research by recruiting, screening, and enrolling participants from the comfort of their homes. This can be a powerful enrollment booster; for example, 70 percent of potential research participants in the United States live more than two hours from the nearest study center. In this article, we’ll explore three ways remote eConsent can tangibly improve your next trial.

1. A seamless participant experience for onboarding leads to accelerated participant enrollment

Many trials face a similar challenge: enrolling sufficient participants. A lag in recruitment and enrollment can be both expensive and even can threaten a trial’s viability. The solution? A remote eConsent designed around the participant. It casts a wider net by enrolling, pre-screening, and consenting participants from any location using mobile apps on their own devices.

When it leverages multimedia components such as diagrams, images, videos, and screen readers, eConsent maximizes participant comprehension. It allows participants to review information at their preferred speed and even get feedback from family and friends. This translates into empowered participants who are joining a trial without feeling pressured or anxious—which can positively impact clinical trial retention later on.

Importantly, remote eConsent can easily be adapted to meet specific participant needs.  Whether a participant has hearing or vision impairment, language or literacy barriers, or s other special needs, eConsent can easily address these. For example, forms can be translated into a participant’s preferred language, font size can be adjusted, and screen readers used to read text out loud.

Of note, an optimal enrollment experience does not ask a participant to switch between applications to complete video calls, signatures, and questionnaires. The more seamless the enrollment process, the greater participant compliance will be.

How Castor supports a seamless experience

  • Participants can sign up through the participant enrollment portal. A pre-screening questionnaire helps filter appropriate participants.
  • After consent, the participant is seamlessly added to the Clinical Data Management Platform and integrated into the study ecosystem.
  • An easy-to-use and out-of-the-box participant enrollment portal can be customized to meet the needs of your trial.
  • A customizable recruitment portal that automates participant recruitment. Branding, copy and pre-screening questionnaires can be added to the participant portal, improving participant workflow and enrollment rates while minimizing sponsors/CRO workload at sites.

2. Increased participant retention through better participant comprehension

Many clinical trials struggle with both enrollment and participant retention. Not only do 80% of trials struggle with enrollment, but some studies estimate that up to 30% of participants who join a clinical trial end up dropping out. Designing and running a study while keeping the participant’s perspective in mind can help at every stage of a clinical trial.

One reason participants drop out of trials is lack of comprehension. The goal of informed consent should not be merely getting a signature. Instead, it should focus on educating the participant on everything involved in the study, and explain the goal of the research. Keeping participants engaged and informed throughout the initial consent process can dramatically impact their overall experience and willingness to continue.

Another source of hesitancy for some participants is the historical lack of diversity within trials. As more studies prioritize diversity amongst participants representative of the distribution of the target disease, researchers need to build trust. An effective way to increase participant trust, engagement, and comprehension is by allowing participants to consult with caregivers and healthcare providers during the trial onboarding process. eConsent can allow participants more flexibility by cutting out site visits where participants may feel pressured to make a decision on the spot.

Additionally, leveraging multimedia elements such as videos, audio recordings, and images to break down complex medical or legal information into understandable language greatly increases participant comprehension. Video conferencing can recreate the benefits of on-site visits by supporting direct online video chats between a participant and a site member. This kind of one-on-one interaction greatly increases participant confidence, which translates into retention.

How Castor supports participant comprehension

  • Video and automated remote Consent visits ensure participant and care-giver comprehension of study requirements
  • Maximize participant understanding of trial requirements and risk with diagrams, images, videos, and screen readers for accessibility throughout the participant onboarding process.
  • Increase engagement and retention by ensuring critical information, prioritized tasks and study context is always available online.
  • Downloadable ICFs ensure sites and subjects can retain copies for their records.

3. Real-time insights for reduced site burden

Proper eConsent forms allow study coordinators to see in real-time where participants are in the enrollment process. eConsent improves overall consent tracking management and greatly decreases the risk of an invalid consent scenario. It also allows study teams to easily notify participants via email or text with updated information—which then ties into the increased participant engagement discussed above.

eConsent also makes it easy for site staff to pinpoint what areas participants are struggling with and what needs to be discussed in more detail. This opens the way for meaningful conversation and guarantees that the participant fully understands what the study entails. If participants have questions, these can be quickly resolved through video chats to ensure that the process keeps moving forward. All of this lightens the administrative workload for sites and study teams while ensuring regulatory compliance.

How Castor supports real-time insights

  • View in real-time study progress and the number of participants screened and enrolled to meet trial timelines and recruitment goals
  • Simplify administrative burden and ensure compliance by monitoring participant consent status in real-time and assign updated ICF versions to ensure meeting protocol requirements.
  • An eConsent dashboard for sites and participants that is optimized for transparency and clear communication.

 

Helping move research forward can be a meaningful experience for participants. But doing so requires an optimized user experience so they feel empowered and committed. At the same time, site teams need efficient workflows throughout consent and re-consent processes. Fortunately, the right eConsent solution can accelerate enrollment, increase retention, and reduce site burden. The future of clinical research is looking bright!

At Castor, we are thrilled to see eConsent studies gaining momentum and IRB reviewers’ eagerness to embrace this new age of progress. If you want help setting up a study that meets IRB requirements, reach out to our friendly team members. We’re not only knowledgeable about all things eConsent—we’re also thrilled to help sponsors and study designers. 

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How Decentralized Trials Can Support Meaningful Diversity

October 6th, 2021 by

With increased awareness of the need for inclusion, equality, and diversity across many industries, the Castor team is thrilled to see an increasing emphasis on diversity of race, gender, and even geography amongst clinical trial participants. Critically, experts call for not just increased diversity on a statistical basis, but that the studied population is representative of the distribution of the disease. 

Many factors—including age, gender, weight, and a person’s ethnic background—can influence how a person reacts to a therapeutic intervention. It’s essential for clinical trials to include an appropriate spectrum of participants to demonstrate the safety and efficacy of a treatment—and if that holds true for a cross-section of individuals in the population a therapy is intended for. 

Clinical trials rely on volunteers to participate in the study, but the ability and willingness to participate is not equally distributed across demographics. It’s therefore important that volunteers are explicitly recruited from diverse backgrounds, or researchers risk biasing the efficacy data toward the ethnic and socioeconomic groups most likely to participate in research. Diversity within trials doesn’t just happen—it requires intentional study design. To this end, decentralized clinical trials (DCT) can support and accelerate diversity within clinical research. In this article, we’ll explore how DCT can successfully address the challenges of maintaining diversity within clinical research. 

The historical challenges

Patients from certain backgrounds have historically had a fraught relationship with the medical system, resulting in a lingering hesitancy to participate in clinical trials today. Due to past injustices experienced at the hands of a system that should have cared for them, many are left feeling distrustful and uncertain of new therapies—and especially of participating in the clinical research required to bring these innovations to market. 

The effects of traumatic history—and a lack of effective initiatives to recruit a diverse participant population—has deeply affected the state of clinical research. For example, a 2019 JAMA Oncology article highlighted the disparities in race reporting and diversity in clinical trials within the cancer field. In their study, they found that only 63% of the 230 trials leading to FDA oncology drug approvals over the past decade included any information about the race of their participants. Of those who did a report on racial diversity amongst participants, only 7.8% of the trials documented the “four major races in the United States (white, Asian, Black, and Hispanic)”. On average, however, 76.3% of participants were white, 18.3% Asian, 6.1% Hispanic, and 3.1% Black. According to the study, “black and Hispanic patients were consistently underrepresented compared with their expected proportion based on cancer incidence and mortality in the United States.”

Unfortunately, this is only one example of inadequate race reporting and representation within landmark trials. In addition to distrust toward medical research, other factors contributing to the lack of diversity in clinical trials include language barriers; overly rigid inclusion and exclusion criteria; and difficulty finding transportation to research sites, which tend to be disproportionately located within areas of certain demographics. Increased efforts are required to eliminate these disparities and enhance representation within clinical research.

The goal

The goal of diversity in clinical trials is to accurately represent the distribution of disease so that the efficacy of a putative therapy can be assessed in the context of its actual use. At this point, it is well-established that certain diseases and genetic disorders are most likely to occur amongst people whose ancestry traces back to certain geographic areas or historical communities. Individuals in ethnic groups often share genes that may predispose one to a certain disease, or alter the pharmacokinetics of medication.

In other words, the clinical trial should focus on the patients who are most likely to need therapeutic intervention. But how can such patients be most effectively recruited and included in a study?

Possible solutions

In November 2020, the FDA published a guidance document with specific, actionable suggestions on how clinical trials can enhance diversity. The most interesting part? Many of these suggestions can be easily implemented through the use of decentralized trial methods. 

Here are some of the specific suggestions made by the FDA, and how DCT supports them:

Recruitment

According to the FDA’s recent guidance, researchers need to ensure “that clinical trial sites include geographic locations with a higher concentration of racial and ethnic minority patients and indigenous populations, as well as locations within the neighborhoods where these populations receive their health care, because restricting clinical trial sites to selected geographic locations may limit the ability to enroll a diverse trial population.” 

DCT solution: DCT makes the enrollment process easier and more accessible to a wide range of participants. Marketing for many trials can be done online, therefore reaching a large target audience. By removing the need for participants to travel to the research site, sponsors can recruit participants from diverse geographic locations if these best accurately represent the disease. 

Site staff

The recent FDA guidance asks researchers to consider “diversity when selecting health care providers and study coordinators to assist with clinical trial recruitment.”

DCT solution: Participants may prefer a health care provider of their same cultural background for many reasons—shared language, perspectives, experiences, etc. By leveraging remote technology and removing the need for site staff to actually be on-site, trials can recruit site staff from a larger demographic.

Informed consent process

The FDA asks researchers to consider “using ‘electronic informed consent’ to allow participants to read and sign necessary forms remotely instead of traveling to a clinical trial site while ensuring that all potential participants, including those with literacy issues, understand all necessary information.”

DCT solution: An eConsent solution allows patients to go through the entire enrollment process online, thus eliminating possible travel difficulties. Each patient’s personal needs can easily be met through language translation, audio and video recordings, and additional information to help patients fully understand the details of the trial. As an added bonus, eConsent can be done at a participant’s preferred pace. Patients are also able to discuss their decision with family and friends and meet with a researcher via videoconferencing to have all their questions answered. All of these factors result in confident decision-making.

Reduced site visits

Another piece of advice from the FDA asks sponsors “to think about reducing visit frequency, when appropriate, in addition to considering whether flexibility in visit windows is possible and whether electronic communications, such as phone, email, social media platforms, or other digital health technology tools can replace site visits and provide investigators with real-time data.”

DCT Solution: Throughout the entire duration of a trial, DCT allows site teams to remain in constant contact with trial participants—sometimes without participants ever having to travel on-site at any point during the trial! A range of digital tools can be deployed to stay connected, resolve questions, and monitor participants’ health status. Decentralized clinical trials (DCT) are collecting many kinds of data remotely through everything from wireless vital sign monitoring patches to mobile-connected products. These innovations benefit both site teams and patients—and make it much easier for trials to retain patients from remote areas. 

The responsibility

Decentralized methods may prove to be the lynchpin in making true progress in the urgent pursuit of achieving true diversity within clinical research. At the same time, this group of tactics is not a magic bullet. Most importantly, clinical researchers must commit to greater diversity within their trials and create metrics to measure progress. It may also mean going above and beyond former recruitment efforts. Some approaches have seen success by prioritizing a helpdesk to troubleshoot technical issues with study equipment or online portals along the way—thus increasing participant confidence and accommodating those who may have less experience with certain digital tools. 

The time is now for diversity within clinical trials. Fortunately, decentralized methods support patient-centric trials and can enhance participant trust while also benefiting site teams. Learn more about how you can use Castor DCT in your next clinical trial here.

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The True Meaning & Value of eConsent in Clinical Trials

July 1st, 2021 by

In June 2011, pharmaceutical behemoth Pfizer announced their plans to secure online participant consent using video/multimedia in an upcoming study. The goal was to enroll about 600 participants from ten states across the United States to assess the safety and efficacy of Detrol LA (tolterodine tartrate), a treatment for overactive bladder. The announcement marked a major first in clinical trials, offering hope of accelerated clinical trials while improving quality and diversifying the participant base.

eConsent mobile form example

Ultimately, the clinical trial was halted after failing to recruit a sufficient number of participants. Its downfall was attributed to trying out too many ideas at once, ranging from online recruitment and consent to at-home study drug delivery and remote tools for all data reporting. Still, Pfizer noted valuable takeaways and vowed to refine their strategy and try again. Most importantly, this study represented the first foray into eConsent.

Progress in eConsent solutions over the next decade was slow, with the clinical research industry overdue to implement quick, secure, and flexible enrollment and consent options. Then the COVID-19 public health crisis arrived and quickly became a major catalyst for eConsent adoption.  The COVID-19 pandemic accelerated the rollout of decentralized trials (DCT) and hybrid trials are rapidly becoming part of the new normal so eConsent is becoming ever more critical in supporting clinical research. So far, evidence indicates that the use of eConsent has advantages over traditional paper methods by:

What is eConsent?

In brief, eConsent is the digital version of informed consent—and one of the first interactions participants have with a study. It must meet all the criteria of informed consent, simply removing the paper from the site and instead using a tablet or computer to capture consent instead. Remote eConsent represents a paradigm shift, where consent can be obtained remotely in the comfort of a participant’s home, local clinic, or anywhere else convenient. It allows participants to be screened, give consent, and enroll into trials remotely without the burden of visiting a research site.

As eConsent platforms mature, exciting new interactive and visual features are being added to increase participant engagement and comprehension, such as:

However, even robust engagement materials are not meant to replace the important discussion between the participant and site staff. The clinical research site will continue to play a critical role in the consenting process.

The evolution of eConsent

Since it was first instituted in the 1960s, written consent to participate in research studies has undergone very little change other than tightening of regulations and increased participant education of their rights. At that time, it was decided that for research to be considered  ethical, participation must be done in a voluntary and informed manner. This decision resulted in an elaborate, paper-based consent process used in all studies until recently. Unfortunately, the goal of informed consent was not always met: to explain research to study volunteers so they could offer truly informed consent.

In March 2015, however, the FDA signalled a seismic shift when it proposed its first ever guidelines for implementing eConsent and laid out an electronic consent meaning. The adoption of eConsent was slow, however, due to concerns of potential risks, longer timelines, and higher costs. There was an overall hesitancy from clinical researchers to embrace an entirely new approach to consent. As is true in all technology adoption life cycles, crossing the chasm to widespread adoption takes time.

eConsent has increasingly become more accepted over the years, however it wasn’t until the COVID-19 pandemic began that it was embraced on a worldwide scale as never before. As research centers closed down, teams working on in-progress studies needed a method to remotely re-consent participants due to protocol amendments. Previous objections to adopting remote consent were overcome by necessity. The industry is now seeking remote consent as a standard for trials instead of novel functionality—and they’ll have plenty of fresh evidence and case studies to back up their requests.

What are the Benefits of eConsent? 

eConsent benefits are numerous, offering advantages to participants, sponsors, and site staff. Such eConsent advantages include quality data collection, improved productivity, automation of reporting, increased valid consent, and improved participant access and engagement.

1. Supports quality data collection

eConsent supports data quality by standardizing the consent process, automating versioning, and reducing ICF entry errors. Depending on the platform, eConsent can also use embedded HIPAA-compliant authorization forms, thereby ensuring FDA compliance and necessary documentation at every step. In the EU, the GDPR’s most recent guidance on eConsent requires “an effective audit trail of how and when consent was given, so you can provide evidence if challenged” and “an appropriate cryptographic hash function to support data integrity.” Fortunately, some eConsent solutions offer access control, encryption, and traceability.

Quickly identifying and correcting errors is also on the list of eConsent benefits. It can trigger timely re-consent notifications linked to protocol amendments or safety updates, ensuring that a study is not stalled or stopped. It also reduces transcription errors since data fields (eg. date of consent) can be copied automatically into the electronic data capture (EDC) system.

2. Improves productivity

Another benefit of eConsent is increased productivity in decentralized or hybrid trials—which is great for both a sponsor’s budget and timeline. Site coordinators spend a significant amount of time hosting onsite source monitoring with CRAs from multiple trial sponsors. Managing paper ICFs is burdensome and error-prone for these inspections, not to mention the required storage, tracking, and maintenance of records. But with eConsent, CRAs can check data remotely without visiting the site, allowing them to concentrate on other site duties (e.g. safety monitoring). Or, a central team can review data in the core system and case report forms (CRFs) for all sites, further increasing team efficiency.

3. Allows automated reporting of data 

Sponsors need to know where sites and participants are in the enrollment process to identify delays and potential risks. The automated data reporting built into some eConsent programs addresses this issue effectively. For example, it can run automated edit checks on completeness of ICFs and trigger alert messages to sponsors in case of eConsent errors. It can also leverage interdependency with core systems such as interactive voice response system (IVRS), CRFs, or the clinical trial management system (CTMS). All of these features can catch flaws in the intake, enrollment, and continued consent process before they threaten data in the study.

4. Increases valid consent  

Every participant in a study represents an investment of time and money—and possibly the key to meeting required participation levels. Invalid consents, however, require hard-earned data to be tossed out. Flaws in the intake and enrollment process can create errors in the order in which consent is documented. At times, sites move along in the trial process without getting the ICF first— thus invalidating data in the study. eConsent, however, requires initials, signatures, and checkboxes coupled with automatic date and time stamps on documents, so trial materials are always audit-ready. eConsent also ensures that participants are always given the most recent IRB-approved version of consent forms, auto-triggering notifications when a re-consent is necessary. 

Another way an eConsent program supports valid consent is by communicating clinical trial information in easy-to-understand formats. Through the use of interactive multimedia components such as videos, images, and audio, eConsent can make it much easier for participants to fully understand the information being presented to them. With better comprehension, participants are empowered to make decisions that they feel confident about. 

5. Improves participant access 

A well-documented problem plaguing research trials is a lack of diversity and inclusivity. In the past, participants were often pulled from populations living near study sites, compounding the problem of underrepresentation. With increased awareness, more trials are actively seeking out diversity of race, gender, and geography amongst participants so that the studied population is representative of the distribution of the disease. 

Individuals who have high-risk health conditions or who live in rural areas are much more likely to be able to participate when eConsent is used because it eliminates travel. eConsent can easily be adapted to meet the needs of a wide variety of participants by addressing language or literacy barriers, hearing or vision impairment, and other special needs. For example, the use of audio recordings, adjustable font sizes, and multiple language formats easily serve the needs of a wider audience. 

eConsent also makes it easier to accommodate participant needs. For example, sites can observe which form sections a participant is spending more time on. If participants have questions, these can be quickly resolved through video chats with the site team. This allows site staff to streamline services and allocate resources according to real needs instead of projected ones.

6. Increased patient engagement & retention

eConsent can ease many common anxieties that participants often experience during the consent process.  By enabling a more interactive experience, eConsent allows participants to go through information at their own pace. When signing a document in person, participants may feel pressured and anxious as they review and sign the document. eConsent offers a refreshing alternative, where participants can take their time with each section of the document, even pausing to reflect or ask for input from family and friends. Any questions that come up can also quickly be answered by a researcher through the video chat feature. Because participants feel actively involved in the study process, they are more likely to feel invested and engaged with the study—leading to higher participant retention.

The eConsent process: from recruitment to retention

A participant’s journey through the informed consent process does not begin and end with a signature. It spans across recruitment, screening, enrollment, consent, and retention. To expand participant access to trials and democratize clinical research, a streamlined and remote-enabled participant experience along all of these steps is critical—and the right eConsent solution will help to do just that. 

Modern researchers are tapping into the power of social media to reach a broader audience. But once they’ve sparked the interest of a potential participant, the next challenge is to convert that interest into engagement. To do so, an online screening questionnaire  can determine eligibility to participate in the study. Depending on the eConsent platform used, potential participants may receive an email directing them to a customized enrollment page to share trial information and answer questions.  

Importantly, digital participant enrollment can make the difference between hitting or missing your recruitment targets. An eConsent enrollment page can use multimedia components (eg. videos and audio recordings) to break down complicated trial information and help participants understand what a trial aims to achieve, and the risks and responsibilities of the participant. Where formerly participants may have been confronted with a 30-page enrollment form laced with legal jargon, with eConsent a thorough online presentation can address participant concerns, empower them, and strengthen their enthusiasm and commitment. 

Video conferencing allows a clinical researcher to join a participant online and answer questions directly, building further trust and commitment to a study. This also allows the study team to verify the identity of the participant. 

Finally, participant retention is one of the most important aspects in ensuring that a clinical trial continues to move forward. Unfortunately, it is also often one of the biggest obstacles. An eConsent solution, however, can alert site staff to follow up with participants who are falling through the cracks by missing check-ins, not entering in data, or skipping lab visits. It also ensures that critical trial information is always available online, further helping with retention as participants can re-read materials or watch videos again.

Meeting the complexities of informed consent 

Clinical researchers are required to fully explain details of treatment to potential participants. It’s important that participants fully comprehend the risks and benefits before deciding whether or not they wish to consent to it. This process is known as informed consent. (Read about it in-depth here: Understanding the Nuances of Consent in Clinical Research.)

What is the criteria of valid informed consent?

Disclosure of information. participants have the right to autonomy, or the right to make decisions about their own health and medical treatments. Researchers must disclose enough information about the trial so that the participant can make an informed decision. Such information could include what the treatment involves, the possible benefits, and risks as well as the likelihood of any risks occurring.

Competency of the participant (or surrogate) to make a decision. This refers to a participant’s decision-making capacity. The participant must have the ability to make and be held accountable for their own decisions. participants must be able to evaluate the personal benefits and costs of each option and see how they relate to their own values and priorities.

Voluntary nature of the decision. participants must be free to consent to or refuse treatment and voluntarily give consent without any coercion or duress. 

eConsent and Regulatory Compliance 

Regulations pertaining to the use of eConsent vary amongst countries. At the time of writing, no EU regulation or guidance about eConsent in clinical trials exists.

In general, the Institutional Review Board (IRB) or ethics committee requirements for paper and electronic consent are the same, although countries and regions differ in exact policy, so an understanding of local IRB guidelines is essential. When making a submission for an eConsent-based study, it’s important to address the following questions:

Using eConsent in a country that does not allow electronic signature

In countries that do not accept eSignature, it may be possible to set up an alternative workflow. Check with your local IRB if a participant can sign a paper form while on a video call, and then mail in that form. Although this method entails paperwork, you retain two key benefits: the eClinical platform tracks the consent status, and participants can access trial information online at any time. 

The future of trials: eConsent

Studies show that on average, the cost of developing a drug is $2.6 billion, and for every day a trial is delayed, sponsors lose a whopping $600,000 to $8 million. eConsent removes several common sources of delays while boosting enrollment and retention. For in-progress trials, eConsent supports efficiency in data processing and continuous regulatory compliance.

The eConsent model can be a flexible, user-friendly, and secure solution to informed consent when built and used appropriately.  It can benefit study participants by putting them at the center of the consent process and offering unparalleled patient education through multimedia elements. It can also offer efficiency gains to researchers by simplifying enrollment and increasing retention. Long after social distancing ends, remote eConsent functionality will no doubt continue to address the growing adoption of decentralized and hybrid trial designs. 

Understandably, some sponsors are hesitant to make the leap to eConsent due to the uncertain regulations or fear of extended startup times and expenses. Switching SOPs and workflows once built for the paper and site process will require change management. However the benefits are massive and—as with the smart phones we carry—in a few years we may wonder how we ever got by without remote eConsent solutions.

Castor’s remote eConsent solution is a powerful platform that puts the participant at the center of the consent process and reduces workload for site staff. Reach out to one of our friendly Castorians to find out how we can set up your next study for success.

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Understanding the Nuances of Informed Consent in Clinical Trials

July 13th, 2021 by

Informed consent is one of the most important aspects of research ethics. Since the 1960s, the moral right of individuals to self-determine whether or not they wish to participate in clinical research has been recognized by regulatory bodies, and it remains one of the most important ethical developments in human biomedical research.

There are strict guidelines and regulations governing how informed consent in clinical research is obtained, which all researchers are bound to follow. Prior to the start of any clinical research, an institutional review board (IRB) or independent ethics committee (IEC) confirms that adequate consent will be obtained in a way that does not jeopardize the rights, safety, or well-being of research participants. However, consent is recorded—whether on paper or electronically—IRB approval hinges on how the criteria of valid informed consent are met, which we’ll explore next.

What is the criteria of valid informed consent?

In order to meet informed consent criteria, clinical researchers must fully explain the study goals and investigational actions to participants. Only once they fully understand the risks and benefits can they voluntarily decide whether or not they wish to consent. In order for consent to be ethically valid, a few critical elements are required. Participants must:

Disclosure of information

Participants have a right to autonomy—the right to make decisions about their own health and medical conditions. To do so, participants must be provided with all the information that a reasonable person in their place would want about possible treatment.
Such information could include what the investigation involves, the possible benefits and risks, and the likelihood of complications. Even rare risks must be disclosed—especially if the harm could be severe. Researchers should encourage participants to ask questions and allow plenty of time for participants to read the informed consent document and provide a copy for them to review. Once all of the required information has been disclosed, participants must also be given an appropriate amount of time to ask questions and discuss their decision with family and friends.
To meet informed consent criteria, a researcher is also obligated to tell a participant about any conflicts of interest. For example, if the researcher is also the patient’s physician, then he or she would need to reveal any ties to the pharmaceutical company sponsoring the trial, or if he or she has a financial interest in the trial’s outcome.
This is an area where remote eConsent shines, allowing all of the information mentioned above to be provided to the participant clearly and efficiently. From the comfort of their own homes, participants are able to access information and review it at their own pace and even involve family members. Multimedia components such as video, audio, and images can break down complex information. Best of all, participants can come back to the information again and again until they feel comfortable in their choice.

Competence

Once adequate information has been provided, researchers have an obligation to ensure that the information is understood by participants. In order to meet informed consent criteria, they must be able to understand the information presented and appreciate the potential consequences of participation. This principle refers to a participant’s decision-making capacity. The participant must have the ability to make and be held accountable for their own decisions. It is important for site staff to ask potential participants questions to ensure they have grasped the information provided. In remote eConsent, videoconferencing with site staff can be used for this purpose.

Voluntariness

Consent for clinical research must be obtained without manipulation, undue influence, or coercion. Due to the vulnerability of participants, sensitivity is required to ensure there is no undue influence and the decision to participate is truly voluntary. For example, if the researcher also works as a physician, then his or her patients must understand that they are free to consent to or refuse participation in the study without repercussions to their patient/provider relationship. Voluntariness extends throughout the entire duration of the trial—participants can withdraw consent at any time.

What are the types of informed consent in clinical trials?

Traditional Consent

Traditional consent occurs when a participant agrees to participate in the study, after meeting the criteria listed above. It is a limited form of consent, as participants are agreeing to have their data used only in the manner laid out during the consent process.
In the past, participants provided traditional consent for a research study by traveling to a study site, meeting with site staff, and signing paper informed consent forms (ICFs). More recently, eConsent has made this process far less burdensome for both participants and site staff by removing the requirement for site visits and offering digital consent and education options. It also prevents the possibility of consent being invalidated due to inadequate information or hard-to-understand language on ICFs. eConsent solutions can use audio, video, and translation options to communicate information in a way that’s easy to understand. Lastly, eConsent allows impartial witnesses to be present via video—and even recorded—ensuring the consent meets regulatory requirements even in a remote use case.

Broad consent

Broad consent is a specific type of consent related to the storage, maintenance, and secondary research uses of both private information and identifiable biospecimens. In a nutshell, broad consent provides the legal basis for institutions to collect, store, and use subjects’ data and identified biospecimens for unspecified future research.  

In the past, for example, if American researchers had not secured adequate consent for a specific research use outside of the preliminary study, they had to either obtain an IRB waiver of consent or remove personal identifiers to use anything they gathered during that study. Now, under a revised Common Rule—as long as regulatory broad consent is obtained—then any subsequent storage, maintenance, and secondary research uses of an individual’s identifiable biospecimens and data would not require additional consent.

Tracking broad consent is now much easier due to eConsent. It provides a traceable electronic trail, leaving no ambiguity as to when and what a participant agreed to. It can also be easily transferred between platforms.

Continued consent

Continued consent refers to obtaining consent repeatedly from its participants throughout the course of the study—even if the initial consent was obtained at their entry into the study. Depending on the research and its goals, informed consent may not be a one-time event but rather an ongoing and dynamic process. Furthermore, providing initial consent does not mean that a participant will agree to continue in the study through its completion. Study participants always have the right to withdraw consent at any point.
Obtaining re-consent is an important ethical aspect in clinical research as new information becomes available. For example, the researcher is responsible to update participants if they discover new information that could affect:

eConsent can save a huge amount of work associated with continued consent. In the past, serious errors sometimes occurred when an obsolete or unapproved version of ICF was used—which is a completely avoidable error when an eConsent solution with version control is used.
In summary, informed consent in clinical research addresses participants’ knowledge, competence, and willingness to participate in research. Castor eConsent is a powerful platform to address each of these critical components. It enables a participant-centric education and consent process while reducing the workload for site staff. Learn more about Castor eConsent

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Digital Therapeutic Cybersecurity: Keeping Participant Data Safe

September 28th, 2021 by

Mention “cybersecurity” and “medical device,” and you’ll probably think of stolen patient data rather than hackers taking remote control of an implanted device. Losing control of patient data carries lasting effects and is perhaps the most serious non-clinical risk on the minds of most manufacturers of smart medical devices. Cybersecurity for digital therapeutics (DTx) follows the same logic, focusing on the more risky scenarios such as data security. The complete picture of DTx cybersecurity includes a longer, better-informed set of risks and mitigating factors. That list takes its cues from medical device manufacturers but must also follow the native logic of software development. 

DTx represents an emerging field of software-driven, evidence-based products intended to “prevent, manage, or treat a medical disease or disorder.” Cybersecurity is a concern for DTx, whether they are being evaluated through clinical research or are aiming at market release. In this series of articles, we’ll walk through the cybersecurity threats and opportunities for DTx, we’ll take a closer look at how data flow affects data stewardship, and ask who are the responsible parties when it comes to cybersecurity in the data flow. Finally, we’ll look at the current cybersecurity regulations (hint: there aren’t many) and talk about preparing for regulations that are being proposed by the European Medicines Agency (EMA) in the European Union, the Food and Drug Administration (FDA) in the United States, the Medicines & Healthcare products

Regulatory Agency (MHRA) in the United Kingdom, and other national regulatory bodies. 

Cybersecurity and Digital Therapeutics Defined

Cybersecurity is a range of topics around “protecting networks, devices, and data from unauthorized access or criminal use.” It includes assessing risks and vulnerabilities, along with designing protections from hacking. Setting a high bar for cybersecurity is in the interest of manufacturers, clinicians, patients, and clinical trial participants, to help ensure widespread adoption of DTx as these products and therapies mature in the market. 

Digital Therapeutics differs from the range of apps we routinely run on our mobile devices. DTx may share the ease-of-use and (hopefully) intuitive user interfaces we expect, but are available only with a prescription and are regulated by national regulatory bodies. Wellness apps that do not carry claims about disease outcomes are not regulated. 

DTx typically has been through rigorous testing, including having met specified endpoints in clinical trials, and more frequently, has completed randomized clinical trials before being released for use in a marketplace. Patel and Butte succinctly show what is at stake with DTx cybersecurity:

Considerations of cybersecurity and data rights are preconditions for the mass adoption of DTx. Similar to prior work regarding connected sensors in medicine, as DTx transfers information over the internet, risks of unauthorized access and manipulation of these products and underlying data could compromise both trust in the product and patient care.

And while DTx are distinct from medical devices, their cybersecurity requirements are primarily a reflection (for the moment) of regulations from the medical device world.

Risks & Vulnerabilities 

Good data stewardship practices will depend on how data flows and where it is stored. Vulnerable data flow points include those open channels that move data from the mobile device to a website or cloud storage. For instance, leaving “Location” on when following directions using Google Maps transmits location information that risks being collected by those other than Google. Other downloaded apps also create risks and vulnerabilities by allowing access and creating signal conduits for the data flow that could be compromised. 

Threats to DTx include data theft, identity disclosure, illegal access to the data, corruption of data, loss of data, violation of data protection, among others. These risks can occur at various points along the path of data movement from user to data storage. No data storage institution is immune from compromise. In subsequent articles, we will go into more detail about specific risks to assess in the flow of data.

Risk mitigation must also consider users of the data: physicians, patients, trial participants, various clinicians with access, and other third parties with a justified interest. Risk mitigation includes encryption protocols and the ability to control data access and data integrity at all times.

DTx tend to be more relevant to cybersecurity than traditional medical devices. Pacemakers or insulin pumps are manufactured according to strict protocols by a handful of regulated manufacturing partners. Typically, their communication and system updates also adhere to exacting standards. DTx, on the other hand, rely on third-party software, from operating systems (Android or iOS) to communication networks adhering to a variety of safety standards, some of which may be less rigorous than demanded by specific medical device standards.

From Wellness App to DTx

If a wellness app team intends to develop DTx, assessing cybersecurity risks and vulnerabilities takes on a renewed importance since DTx make use of protected health information while wellness apps do not. Pivoting toward a DTx offering involves asking key cybersecurity questions, as submission to a regulating body like the FDA will include a thorough cybersecurity evaluation. The range of questions is rigorous enough to consider hiring a Chief Information Security Officer (CISO) to dive deep into the needed risk assessments. Risk assessment for the wellness-turned-DTx team would focus on where the protected data resides, moves, and how to protect that data at all points. This sophisticated set of questions and answers involves a serious, ongoing effort.

Cybersecurity Opportunities

Preparing to meet DTx cybersecurity threats and regulations is an opportunity to take another look at DTx development. FDA guidance encourages device manufacturers to assess the level of cybersecurity risk their products might carry and meet those risks with designed-in controls that minimize the risk. The FDA guidance has four aims:

Though this guidance has not proceeded to become regulation, it is de facto industry standard. ISO 14971 outlines the parameters around assigning criteria for assessing risk for medical devices and benefits DTx manufacturers looking for risks and vulnerabilities.

Assessing cybersecurity risks and vulnerabilities will play a role in readying a DTx product for widespread adoption. DTx companies will need a thorough assessment of data capture and data flow to ensure the strictest cybersecurity protocols.

 

 Patel, NA, Butte AJ. Characteristics and challenges of the clinical pipeline of digital therapeutics. npj Digital Medicine (2020) 3:159 ; https://doi.org/10.1038/s41746-020-00370-8. 2

 Casalicchio E, Filetti S, Grigolo D, Mancini LV, Mei A, Pagnotta G, Ravizza A, Spognardi A, Stefanelli S. “Data protection and cybersecurity in digital therapeutics.” Tendenze: Special Issue 4/2021. 64.

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The evolution of eConsent

September 1st, 2021 by

Since it was first instituted in the 1960s, written consent to participate in research studies has undergone very little change other than tightening regulations and increased participant education of their rights. At that time, it was decided that for research to be considered ethical, participation must be done in a voluntary and informed manner. This decision resulted in an elaborate, paper-based consent process used in all studies until recently. Unfortunately, the goal of informed consent was not always met: to explain research to study volunteers so they could offer truly informed consent.

evolution of econsent

In March 2015, however, the FDA signaled a seismic shift when it proposed its first-ever guidelines for implementing eConsent and laid out an electronic consent meaning. The adoption of eConsent was slow, however, due to concerns of potential risks, longer timelines, and higher costs. There was an overall hesitancy from clinical researchers to embrace an entirely new approach to consent. As is true in all technology adoption life cycles, crossing the chasm to widespread adoption takes time.

eConsent has increasingly become more accepted over the years, however it wasn’t until the COVID-19 pandemic began that it was embraced on a worldwide scale as never before. As research centers closed down, teams working on in-progress studies needed a method to remotely re-consent participants due to protocol amendments. Previous objections to adopting remote consent were overcome by necessity. The industry is now seeking remote consent as a standard for trials instead of novel functionality—and they’ll have plenty of fresh evidence and case studies to back up their requests.

Castor’s remote eConsent solution is a powerful platform that puts the participant at the center of the consent process and reduces the workload for site staff. Reach out to one of our friendly Castorians to find out how our remote eConsent solution can set up your next study for success.

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Regulating Digital Therapeutic Cybersecurity: Today and Tomorrow

December 17th, 2021 by

Cybersecurity has increasingly become a concern for Digital Therapeutics (DTx) developers and regulatory bodies. DTx are vulnerable to security threats, and breaches in security could cause harm up to and including life-threatening situations. Today, many governmental and regulatory bodies offer general security guidance, but this may change soon. Increasing requirements may affect the time and money DTx developers spend investing in security and the penalties for security compromises. DTx developers can prepare for tomorrow by implementing strong security practices today.

regulating digital therapeutic cybersecurity man checking watch device

Current vs. future regulations

Regulatory bodies such as the United States Food and Drug Administration (FDA), United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), and the European Union Medical Device Coordination Group (MDCG) all have guidelines and recommendations for security for medical devices (including applicable DTx). 

However, the number of security requirements may soon increase as security compromises become a more prominent concern. For example, though the FDA presents security breaches as a serious threat, they do not legislate measures such as premarket security audits. In the future, DTx developers may need to accommodate more security measures. 

According to Nisarg Patel and Atul Butte’s recently published article in Nature, regulators are pushing for changes to increase security requirements.1 Patel and Butte’s insights on changing requirements refer primarily to the DTx market in the US but are easily translatable for DTx developers in the UK and EU. Regulatory advocates are pushing for the following: 

Requiring additional audits and more visibility could help protect DTx from security threats. DTx developers will need to adapt by including security in plans, trials, and assessments. 

FDA tiers of risk

Currently, the FDA divides medical devices into two tiers of security risk: Higher Cybersecurity Risk (Tier 1) and Standard Cybersecurity Risk (Tier 2). Tier 1 devices can connect to another medical or non-medical product, a network, or the internet. Security breaches to Tier 1 devices could directly harm multiple patients. For example, the FDA would classify an insulin pump that connects with a home monitor and software programmers as a Tier 1 device.2

Tier 2 devices are not capable of connecting or having a breach like Tier 1 devices. An example of a Tier 2 device is a coronary atherectomy device that does not connect to outside networks. Although most DTx do not include implanted devices, their high degree of connectivity puts them at increased risk for security threats. If DTx are connected and capable of causing harm to many, they may fall under Tier 1. 

The FDA requires DTx developers to determine their device’s risk and implement appropriate security measures. Then the FDA evaluates the resulting security report instead of independently evaluating the device’s security. Currently, the FDA does not require premarket security audits for medical devices or that developers include security reports in public-facing product summaries.

MHRA and EU guidance

Like the FDA, the MHRA and EU provide guidance for medical device security. The MHRA regulates medical devices in the UK. The UK’s National Health Service (NHS) Digital program works alongside the MHRA to help medical device developers with security. NHS Digital provides helpful security recommendations for reference.3

The EU’s Medical Device Coordination Group (MDCG) published guidance in 2019 on security for medical devices. The document calls special attention to where security and patient safety risks overlap. For example, weak security may allow device compromise and risk to patient safety. However, overly restrictive security may prevent patients from getting the help they need from professionals.4 MDCG recommends finding a balance between security and safety (Figure 1).

security-risk-safety-risk
Figure 1. Security risks may impact safety (modified from MDCG guidance document)

 

Regulatory bodies provide valuable insights

Prepare for additional security regulations by reviewing and applying current guidance. Regulatory bodies present an abundance of practical advice on how to prepare. Alongside preparation, remain mindful of the intended function of your DTx product. The goal is a secure yet functional therapy.

Create a cybersecurity strategy

Both NHS Digital and MCDG offer in-depth guidance on establishing robust security measures. NHS Digital has a 6-step mitigation plan to protect medical devices connected to clinical networks from security breaches. Although technically for clinical networks, NHS Digital’s plan includes information applicable to DTX. The plan covers everything from identifying weaknesses to preventing compromises, reducing the impact of potential compromises, and planning for periodic reviews.

MCDG guidelines cover everything from conducting risk assessments to configuring information technology architecture to managing risks across a product’s lifecycle. These guidelines offer comprehensive and practical steps to ensure the safety of devices and the patients who use them. Even DTx developers operating outside of the EU regulatory market would do well to review these guidelines before creating a security strategy.

Delivering a trustworthy device

The FDA criteria for a trustworthy device fit nicely in the niche between security and usability. Criteria are as follows: 

  1. Secure from security intrusion and misuse
  2. Provide availability, reliability, and correct operation
  3. Perform intended purpose  
  4. Adhere to security procedures

Trustworthy devices balance security, operability, function, and procedural adherence. DTx does well to document security measures. Documentation helps with approval or clearance from regulatory bodies and adds to provider, payer, and public confidence. 

Creating secure DTx programs is becoming paramount for developers, and regulatory advocates are pushing for additional requirements to protect against breaches. DTx developers must invest in the time to create therapeutics that balance function with robust security.

1Patel NA, Butte AJ. Characteristics and challenges of the clinical pipeline of digital therapeutics. npj Digital Medicine (2020) 3:159 ; https://doi.org/10.1038/s41746-020-00370-8.
2Content of premarket submissions for management of cybersecurity in medical devices. US Department of Health and Human Services. https://www.fda.gov/media/119933/download. Issued October 18, 2018. Accessed September 22, 2021.
3Guidance on protecting medical devices. NHS Digital. https://digital.nhs.uk/cyber-and-data-security/guidance-and-assurance/guidance-on-protecting-medical-devices. Last edited July 1, 2020. Accessed September 28, 2021.
4MDCG 2019-16 guidance on cybersecurity for medical devices. Medical Device Coordination Group. https://ec.europa.eu/docsroom/documents/41863. Published December 2019. Accessed September 28, 2021.

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Today’s Challenges for Digital Therapeutics

January 5th, 2022 by

DTx growth transcends old barriers, presents new challenges

Recent years have seen transformative technological advances—pushed partly by the urgency generated from the COVID-19 pandemic. The need to evolve has affected many industries, Digital Therapeutics (DTx) included.1 DTx manufacturers face fresh challenges in completing clinical trials and commercializing their products. Thankfully, with careful planning and help from the right allies, DTx manufacturers can successfully adapt.

todays-challenges-in-digital-therapeutics

DTx are evidence-based software programs that allow patients and (remotely) their care teams to prevent, manage, or treat a medical disorder or disease.2 DTx usually focus on chronic and behavior-modifiable conditions—everything from diabetes to insomnia to substance use disorders. DTx push the boundaries on what is possible when healthcare meets tech. For example, Renovia’s FDA-approved leva® provides potentially more effective relief than traditional interventions for chronic fecal incontinence.3 Like other medical interventions, such as medications and medical devices, DTx undergo rigorous testing for approval and use.  

DTx market expanding

Grand View Research’s recent report on the DTx market projects expansion at an astonishing 23.1% compound annual growth rate from 2021 to 2028. The following factors can explain this growth:4

  1. As awareness of DTx grows, patients, providers, and payers are now accepting them as valid treatment options.
  2. The pandemic has highlighted humanity’s need for mental health services and convenient and accessible digital health solutions. 
  3. Pandemic-generated urgency changed the pace of regulatory approval. Regulation requirements were suddenly widened to accommodate new and higher-tech approaches to research and medicine. Revisions may speed up the overall regulatory support for next-generation medicine. 
  4. Increased smartphone usage across the globe means more access to DTx and remote healthcare.    

Emerging challenges

New challenges have replaced previous woes despite growing acceptance and the healthcare industry’s increasing demand for DTx. In May 2021, Castor interviewed Chris Bergman, president of Amalgam Rx, about his thoughts on the future of DTx. Bergman identified previous issues as lack of funding, regulatory ambiguity, and a hesitant market. Current issues, according to Bergman, have shifted to establishing evidence, creating adequate payment and business models, and effectively increasing distribution and scale. A few years ago, DTx were scrambling to navigate regulations and establish themselves as valid healthcare options. Today they are making changes to improve growth and prove efficacy.5

Planning for new challenges

DTx manufacturers can meet today’s challenges through careful planning during the development stage. According to Bergman, DTx manufacturers do well to consider the following before commercializing their products:

Another way to meet new challenges is through strategic alliances. Data management platforms, such as Castor, can fill gaps in DTx manufacturers’ experience in trial development, security, and management. Utilizing innovative tech in clinical trials saves time and money, protects patients’ data, and contributes to trial success—a must in today’s healthcare scene.

The COVID-19 pandemic brought unforeseen changes to the DTx market. Initial challenges such as payer adoption, patient acceptance, and (even) regulatory ambiguities no longer stand at the forefront of challenges for DTx manufacturers. Instead, manufacturers have to deal with how to prove efficacy and ensure product distribution at scale with proper reimbursement. Investing in trial tech, such as Castor products, will help DTx manufacturers meet these challenges. 

 

1Llopis G. Digital Therapeutics are accelerating personalization in healthcare. Forbes. https://www.forbes.com/sites/glennllopis/2020/08/09/digital-therapeutics-are-accelerating–personalization-in-healthcare/?sh=34001c2c2176. Published August 9, 2020. Accessed September 3, 2021.
2Understanding DTx. Digital Therapeutics Alliance. https://dtxalliance.org/understanding-dtx. Accessed August 26, 2021.
3Renovia. October 29, 2021. Renovia receives Breakthrough Device Designation for leva® Digital Therapeutic as first-line treatment for chronic fecal incontinence [press release]. https://renoviainc.com/2021/10/fi/.
4Digital Therapeutics market size & trends report, 2021-2028. Grand View Research. https://www.grandviewresearch.com/industry-analysis/digital-therapeutics-market. Published April 2021. Accessed September 3, 2021.
5The future of digital therapeutics and the impact on care. Linus https://www.thelinusgroup.com/blog/digital-therapeutics. Accessed September 3, 2021.

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