A Digital-First Mindset Shift on eConsent

September 26th, 2023 by

eConsent plays a pivotal role in optimizing modern clinical trials, but the nuance around eConsent adoption for pharmaceutical and medical device companies remains a consideration for implementation teams. Castor CEO & Founder – Derk Arts MD, Ph.D. recently sat down with Leanne Walsh of Northern Light Lifescience to talk about the challenges, processes, considerations, and mindset shifts that study teams must consider when reviewing eConsent for their trials.

From the conversation between Derk and Leanne, as well as the audience Q&A, it’s clear that the question of eConsent isn’t so much of a “Why?” but a “Why not?” As one attendee noted, “This sounds like people [are] using eConsent in exactly the same way as paper though—in the clinic alongside a face-to-face conversation. If it is used as a tool to provide information to potential participants ahead of a clinic meeting or as a follow-up to the clinic, then it could add more value.”

Here are some of the key themes from the discussion:

eSignature vs. eConsent vs. Digital Signature: Are they the same?

The first barrier to eConsent adoption is getting over regulatory uncertainty. On the sponsor and site ends—especially in terms of signature use, misconceptions about “eConsent is only the eSignature” are still very prevalent. eConsent allows for additional sources of information that the participant can review ahead of time. All of this capacity is contained within the eConsent ecosystem and can happen before a visit to the site. Educating study designers and IRBs to understand that the informed consent process is its own ecosystem rather than just the signature element is a crucial step to break out the parts of eConsent that go well beyond just eSignature.

An electronic signature is always integral to eConsent. However, eSignature requirements vary by country, impacting eConsent adoption. In countries that do not accept eSignature, Castor’s research indicates that a participant can often sign a paper form while on the 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.

“People’s perceptions are different right down to the basics around a signature and digital signature. Are they the same thing? And do they mean the same in the regulations from the FDA versus in Europe? Vendors should be responsible to convey what it means, clarify those terminologies, and make it simple for the study teams to understand.“

– Leanne Walsh, Director, Northern Light Lifescience

Read more from the FDA on Informed Consent for Clinical Trials. 

Digital vs. analog systems: Can eConsent enhance data retrieval over traditional paper processes?

The shift from analog to digital systems in the consenting process is not merely a trend but a necessity. Picture the traditional paper-based consenting process: physical folders, stacks of papers, and the ever-present risk of misplacing a crucial document. This analog approach, although familiar, presents challenges. As the volume of participants grows, so does the paperwork, leading to an increased risk of data loss.

Building on the insights from the webinar, there is an undeniable “wait and see” approach when it comes to adopting new technologies. This hesitancy is often rooted in the challenges of implementing features and the perceived complexities of digital systems.

But let’s debunk a myth: digital systems, especially in the consenting process, are designed to secure data storage. With everything stored electronically, data accessibility becomes seamless. If the study team needs to pull up a specific patient’s consent form, it is only a click away.

“What’s stopping sponsors from engineering their way into accessing clinical data is the concern that all the paper will get digitized in some shape or form and stored somewhere that is completely untraceable […] There’s no way a response would break into a digital system and override whatever access they have to. Then review data that they are not supposed to have access to. So I think it is unequivocally true that digital systems are actually safer and better in restricting access to information or giving access to the right information than analogue analog systems.“

– Derk Arts, CEO & Founder, Castor 

Shifting to a “digital first” mindset creates a larger move toward eConsent adoption among sponsors

The “digital first” approach not only highlights the safety and security benefits of eConsent over paper, it also helps study designers and IRBs experience the expanded capabilities of the whole eConsent ecosystem out in the open. Seeing the eConsent capabilities allows the clinical staff and study designers to plan for how to deliver the extra information that is customized to specific needs of participants.

Digital systems can enhance the patient experience by allowing researchers to develop tools that are more efficient, interactive, and personalized. They can give study participants enough flexibility and time to be better prepared for the consultation with clinicians, formulate questions, or use the waiting time efficiently if the tools are used in the waiting room.

However, the success of this approach hinges on timely adoption. By embracing the digital first mindset from the get-go, study teams can ensure that eConsent isn’t an afterthought but a foundational pillar of the study design. This proactive approach can catalyze conversations, ensuring that sponsors are aligned and onboard from the outset.

Watch the on-demand recording of eConsent from Sponsor to Site: Navigating Successful eConsent Adoption to take in the full conversation and hear about the impact of eConsent, real-world examples of eConsent evaluation, readiness, and implementation, and potential for future industry adoption. 

Discussion Highlights: 

 

Castor’s product suite ensures security, access, and ease of use for sponsors. Our ongoing innovations keep Castor software and technology poised to meet the expanding needs of clinical trials. Ready to learn more? Let’s chat.

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Don’t Overengineer It: Hybrid Designs Overcome Barriers in DTx Clinical Trials

October 11th, 2023 by

Digital therapeutics (DTx) companies have big questions to answer when designing clinical trials—how to engage diverse populations, bridge gaps in the digital divide, and incorporate usable data from wearables, to name a few. At DTx East 2023, Castor’s Head of Solutions, Kristen Harnack, joined the “Challenges and Solutions in Conducting Clinical Trials for Digital Therapeutics” panel to unpack these issues and discuss solutions.

The panelists from Big Health, Philips Pharma Solutions, HelloBetter, and Castor highlighted key solution takeaways, including careful trial planning at the outset, the importance of a flexible mindset for the full trial team, and an acceptance of tools that help operations. Kristen may have said it best, “We see a lot of people get in trouble because they add lofty things they want, [which extends] their timelines and overcomplicates what could have been simpler. Don’t overengineer it.”

Here are some major themes from the panel discussion:

Overcoming risk-aversion is the first step to DCT adoption

The session began by discussing wearables and integrated devices in DTx clinical trials. Decentralized clinical trials (DCT) technology can capture data from the remote sources many DTx companies use to deliver care outside of a traditional clinical setting. DCT technology can capture the real-world effectiveness of treatments, offering exciting opportunities for enriching datasets and reaching new populations.

The panel noted that in some cases, trial sponsors and research sites worry that adopting DCT technology will jeopardize efficiency or complicate regulatory approval. When the stakes are high and the process is already complex, the choice is often to avoid the uncertainty of investing in something new and stick with traditional methods. This risk-averse approach is a major barrier DTx must overcome to take full advantage of DCT technology.  

Raising awareness of the benefits of DCT technology, working to find ways to standardize data, and advocating for improved regulatory approval processes can all increase DCT adoption. The first step to gathering evidence through a clinical trial using DCT technology is to find the right partners and prepare thoroughly. 

“It’s not rocket science to build out an evidence base, but you need to have the right people on board with the right expertise […] You need to make sure you partner up with the right organizations but also be prepared to develop your own standing in this case, you need enough money, enough time, room for error.“

– Elena Heber, Co-Founder and Chief Clinical Officer, HelloBetter

Setting up DCT technology early improves DTx trial timelines

Despite the risk-averse environment, DCT technology is gaining traction in DTx clinical trials. Now that DCT technology has been used for several years by early- and mid-adopters, its benefits are becoming apparent for DTx companies still on the fence (or looking in from the outside).

Panelists explained that as recognition of the benefits of DCT technology rises, more DTx companies are willing to use it in their trials. DCT technology is a natural starting place for DTx clinical trials (compared with pharmaceutical or medical device clinical trials) because many DTx treatments already rely on technology. 

For example, integrating DCT technology like electronic consent (eConsent) seamlessly with existing software helps reduce trial timelines. Kristen also noted that Castor has seen recent eConsent successes with “… 17,000 patients enrolled in [one] trial in 15 weeks” and highlighted that these continued successes will only add to the recognition of DCT technology. 

“If you have your development program set up properly, your phase three can leverage phase one in terms of devices and decentralization. But you have to set that up early. That’s the bottom-up approach we need.“

– Tim Callahan, VP of Scientific Affairs, Phillips Pharma Solutions

Hybrid trials help reach diverse populations

Panelists discussed the importance of including diverse populations in DTx clinical trials so that results are not biased towards certain groups and the challenges of ensuring enrollment representative of varied race, gender, and socioeconomic statuses. 

The consensus was that increasing diversity in clinical trials is a nuanced matter that requires early planning, conscious effort, and investing time and resources into learning how to reach underserved communities. As Elena Heber puts it, “Diversity in clinical trials doesn’t just happen. We all need to be aware that it needs a conscious effort to make that happen.” 

Community involvement is critical to improving participant diversity because establishing trust and relationships with underserved populations happens at the ground level and often in person. This fact seems at odds with DCT technology and DTx treatments, which are often remote and require personal devices, technological know-how, and internet access. How can digital tools be implemented at a personal level, especially in areas with varied socioeconomic populations?    

The answer is a hybrid approach—involving both influential community organizations and efficient, user-friendly DCT technology.

“Any trial can be a hybrid trial. You can get the benefits of both. Having local organizations involved, who are going out to churches and community centers, and they have a relationship and they have a reputation with the community. Allowing them to use those technologies to reach those people more efficiently.“

– Kristen Harnack, Director of Solutions Counseling, Castor

Last thoughts from DTx East: 

 

Castor’s product suite seamlessly integrates with DTx technology to collect data during clinical trials. Our ongoing work to simplify workflow for trial participants and site staff keeps Castor software poised to meet the unique needs of DTx companies just starting clinical trials. Book a demo with our team to learn more!

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10 FAQs on eConsent

November 14th, 2023 by

As the life science industry moves towards digitalization, eConsent has become an efficient tool to replace traditional paper-based processes. It eliminates roadblocks for patients, sponsors and site staff and engages all of those involved with a simple experience and easy-to-use system.

In the pursuit of gaining a deeper understanding of eConsent in clinical trials, we have gathered the 10 most frequently asked questions. These questions address the complexities of adoption, integration, and compliance measures, which provide valuable insights for those who are considering the implementation of eConsent in clinical trials.

1. Is eConsent only for virtual consenting? 

No! eConsent systems should be able to support a variety of workflows to account for a range of patient populations and site needs. A flexible eConsent platform allows you to consent in-person, virtually, or even on paper, all in one platform.

Castor eConsent supports hybrid workflows with visuals, videos, and screen readers, allowing for a process that makes participants feel comfortable, informed, and in control. The platform allows the study team to make video calls, sign forms, and send questionnaires to patients with no additional integration required. Therefore, the study team can view and track their participants’ screening and enrollment progress in real-time.

“With remote consent, you are removing typical geographic barriers to entry, and using our video functionality, you can build a better, more engaging consenting experience with your participants. This positively impacts enrollment timelines and may enable you to recruit from a more diverse pool of participants.”

– Dualtagh Franklin-Charlesworth, Solutions Consultant, Castor

2. What impact has eConsent had on recruitment and patient retention rates?

eConsent has revolutionized the patient recruitment and retention process by streamlining and simplifying the consent process. By digitizing the information and making it more accessible and interactive, eConsent allows for better comprehension and engagement, thereby increasing recruitment rates. Patients can review the consent form at their own pace, revisit sections, and access multimedia content to better understand the trial. This fosters a sense of trust and transparency, making patients more likely to enroll and stay committed to a trial.

Furthermore, with eConsent, data is securely stored, making it easier to keep track of your patient’s progress throughout the consent process. The platform also allows study teams to send reminders to patients regarding consent forms that are awaiting their signature.

“We’ve seen great successes with recruitment using eConsent recently, especially when eConsent is adopted with strategic intent. For example, one of our clients running a pediatric study is seeing a 65% higher enrollment rate with Castor eConsent, compared to previous studies without use of the platform. Other examples include groups who have taken months off their recruitment timelines using eConsent. “

– Kristen Harnack, Director of Solutions Consulting, Castor

3. How does eConsent deal with the complexities of participant identity verification in clinical trials both on-site and remotely?

As part of the consenting process, sites must verify the identity of the participant, confirming that the person providing consent is the intended participant. This is important both from a regulatory perspective and from an ethical perspective to help ensure the safety and well-being of participants taking part in the clinical trial.

During onsite consenting processes, this process is managed as part of the site’s standard operating procedures (SOPs). When utilizing Castor eConsent within an onsite setting, the same principles apply and sites manage the verification of participant identity via their SOPs. Castor eConsent also provides a helpful reminder for the site user to conduct this process by requiring them to confirm that the participants identity has been verified before the informed consent form can be opened for signature onsite.

For remote consenting processes in Castor eConsent, participants are required to create an account within the Castor eConsent patient portal using their email address and a password that they set. When providing an electronic signature on an informed consent form remotely, participants are required to authenticate using their email address and password. This ensures compliance with the relevant regulations including 21 CFR Part 11.

4. How does Castor’s eConsent system support version management, and what mechanisms are in place to notify participants of updates?

Mid-study amendments to the protocol may require updates to be made to the informed consent form (ICF). Participants may also be required to re-consent based on the updated ICF. Castor eConsent can help efficiently manage this process and supports re-consent both at sites or remotely, depending on the study requirements.

In instances where amendments need to be made, the ICF can be duplicated and updated to reflect the changes. Upon approval from the Institutional Review Board (IRB) or ethics committee, the updated version can be published and made available to sites for use. 

Clear statuses are assigned to each ICF within the Castor platform to ensure that sites are only able to access the most up to date version of the appropriate ICF. Importantly, the ICF version number, version date, protocol number and IRB approval date can also be recorded to ensure the documentation is correctly version-controlled. A major benefit of this is it helps to reduce non-compliance at sites and reduce the risk of outdated or incorrect versions of the ICF being used. 

For participants re-consenting remotely, they are notified via email and can access the updated ICF through the Castor eConsent patient portal for remote signing. For participants re-consenting at the site, they are notified by the site and can review and sign the updated ICF during their visit. By being able to support this hybrid approach, Castor provides flexibility and ensures re-consent is captured efficiently based on the needs of the patient and site.

“It’s good to remember that when using eConsent from Castor, you can ensure that sites are always using the latest and greatest informed consent form (ICF).  This reduces risk and ensures a smooth, efficient signing process for patients whether they are providing initial consent or re-consenting to an updated version of the ICF.”

– Dualtagh Franklin-Charlesworth, Solutions Consultant, Castor

5. Can eConsent be built and tested without revealing personal identifiable information (PII)?

eConsent can be built and tested without revealing personally identifiable information (PII). During the development and testing phases, developers can use de-identified, anonymized, or synthetic data to simulate real-world scenarios and validate the functionalities of the eConsent system. This ensures that the system is rigorously tested for accuracy, reliability, and security without compromising patient privacy.

In practice, eConsent systems are designed to uphold the highest standards of data protection and privacy. Castor’s eConsent incorporates robust encryption and access control mechanisms to safeguard PII. Additionally, these systems are compliant with data protection regulations such as the General Data Protection Regulation (GDPR) in Europe and the Health Insurance Portability and Accountability Act (HIPAA) in the United States, ensuring that PII is handled with the utmost care and confidentiality.

“Castor has strict security around any personal identifiable information (PII) gathered.  Any demographic data gathered for tokenization by a sponsor, or CRO will be strictly controlled and encrypted. The sponsor or CRO will not have access to that PII. It will only be available to clinical staff with proper levels of permission.”

– Kristen Harnack, Director of Solutions Consulting, Castor

6. Which countries have adopted eConsent? How can I find out about my country?

eConsent has been adopted in many countries across the globe, particularly in regions with advanced healthcare and technology infrastructures such as North America, Europe, and parts of Asia-Pacific. Regulatory bodies in these regions, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have issued guidelines and frameworks to facilitate the adoption of electronic informed consent in clinical trials. 

Locating country-specific information about eConsent adoption requires studying the records of the agencies that govern clinical trials in each country. Castor has a white paper that tracks the status of eConsent adoption across 18 countries. Stay tuned to our resources page for our forthcoming updated resource, eConsent readiness in 24 countries.

7. How do Castor eConsent and Castor EDC interact?

Castor’s eConsent and Electronic Data Capture (EDC) systems can work in tandem to streamline the clinical trial process, enhancing efficiency and ensuring compliance. eConsent is the initial step where participants provide their informed consent digitally, while Castor EDC is utilized for the collection, storage, and management of the trial data. The interoperability between the systems helps simplify and secure the way data is handled in clinical trials.

Once consent is obtained in Castor eConsent, the participant’s data, such as demographic information and consent status, is automatically transferred to Castor EDC. By having a continuous flow of data between the consent process and the data capture phase, researchers can review real-time information, patient-reported outcomes assessments, and other documentation made possible from central cloud storage that is immediately accessible to the clinical teams. 

8. What integrations are available with Castor?

Castor is a fully interoperable platform that can integrate with many sources of data, such as devices/wearables, EHR’s and other tech systems. 

The Castor platform is an API-first product – meaning we develop the API endpoints before developing the front-end features, allowing for strong integration capabilities. We have also built webhooks for eConsent, which enable efficient, real-time integrations with external tools. 

9. Is eConsent an additional cost when building eCRFs? 

We recognize that sponsors and clinical teams designing clinical trials have different requirements they need to fulfill. Given the diversity of current clinical trials, a one-size-fits-all approach to clinical trial administration makes little sense. Castor solutions are priced with those truths in mind.

“The Castor portfolio of products is definitely modular. You can pick and choose the elements you need for your study. The elements include Enrollment, Pre-screening, eConsent, EDC, and others. So, eConsent is its own line item.”

– Sébastien Bohn, Head of Product Management, Castor

10. Can I do a test environment in Castor eConsent?

Yes – It is possible to create a test environment with Castor’s eConsent. Our team is happy to find the best solution to meet your study’s needs. Contact us today to learn more.

Still wondering if Castor’s eConsent fits in your workflow? Watch the on-demand recording of the Product Spotlight webinar “Dive deep into Castor’s eConsent” to hear the full conversation and see a demonstration of the solution.

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AKRN optimizes patient assessment collection with Castor ePRO

November 21st, 2022 by

This is the third of three case studies covered in a webinar Castor held with AKRN Scientific Consulting. Watch the webinar for more insights from the AKRN team. You can also download this case study below.

Click here to download this case study as a PDF

 
Over-the-counter (OTC) drugs play an important role in accessible and affordable healthcare. According to a recent survey, 90% of European consumers believe self-care is a necessary part of managing minor ailments, chronic conditions, and diseases. This is an issue that not only affects European countries but also has the potential to create large-scale global cost savings. A study of seven European countries found that an increase in self-medication could save more than €11.5 billion for health systems annually.1 Consumers are eager to have the tools and treatments to take care of themselves, but they need OTCs to be accessible and available first.

AKRN optimizes patient assessment collection with Castor ePRO

Company Z’s device is designed to help patients with earwax blocks both prior to and after surgical removal. The substance loosens wax and makes it simpler to remove after it’s sprayed into a person’s ear, while also reducing irritation. Realizing the potential of their product as a highly-effective OTC product, Company Z teamed up with their experienced medical device CRO partners, AKRN Scientific Consulting, to do a clinical study to demonstrate the effectiveness of their solution.

The project was originally straightforward, with approximately 100 participants at a handful of locations across Europe. However, obtaining a thorough grasp of how their product affected real-world consumers and gaining regulatory clearance was an ambitious aim. AKRN had to deploy three unique patient surveys to give investigators a complete view of the product’s simplicity of use as well as what symptoms people reported before and after using the spray. Patient demographics made conducting this study even more challenging. The ear wax removal spray would be used primarily by elderly individuals. AKRN needed to find a technology solution that was easy for elderly patients to understand and navigate.

Designing a seamless workflow for electronic patient-reported outcomes (ePROs)

 

Designing a seamless workflow for electronic patient reported outcomes

Experts at AKRN found the affordability, accessibility for all participants, and seamless electronic data capture (EDC) integration they needed with Castor.

Native integrations enabled data to flow seamlessly between the patient-facing mobile application, where patients enter their data, and the clinical data management system, where researchers can analyze patient data. With ePRO available natively within Castor, survey data entered by patients would populate directly within their EDC system for researchers to review, saving time testing external integrations and the budget needed to purchase them.

For this study to be successful, ePRO surveys had to be accessible to the elderly patient population enrolled. Castor’s surveys were able to be designed and distributed in a way that felt familiar and comfortable for participants. Each participant received a simple email with a link to complete the survey, on their own devices and on their own time. If a participant wasn’t comfortable filling out the form on their own, they had the option to complete the survey with a provider during an in-person visit. With Castor, providers could easily print the surveys, hand them to participants to fill out, and enter results into Castor EDC.

Collecting feedback from participants in a real-world setting

Capturing accurate feedback from patients in a real-world setting was essential for the study’s success, and Castor’s ePRO proved to be the ideal platform for engaging with patients as they lived their everyday lives.

Feedback from patient outcome assessments gave AKRN and Company Z an acute look into how patients felt about their product, how easy it was easy to use for the average layperson, and whether they noticed symptom relief. This feedback was essential to ensure that the product met the needs of consumers looking for an OTC solution that was easy to incorporate into their routine, while effectively relieving ear wax blockage and irritation.

“It was a bonus feature to give patients the opportunities to actually report outcomes to know their story in a different way, a different place, from the patient themselves.”

– Iñigo Marquet De Solís, Clinical Research Scientist & Data Manager, AKRN By Namsa

Enabling patients with a solution to manage their health

An ePRO solution that was easy for participants to use enabled AKRN and Company Z to engage with a participant population that, on their own, might struggle with a technology solution that they’ve never used before. Castor’s familiar, easy-to-use ePRO surveys made real-world data collection possible, all while helping AKRN and Company Z conserve their budget and IT resources with native EDC integration. With an effective ear wax removal solution on the market that anyone can purchase over-the- counter, AKRN and Company Z are giving ear surgery patients a qualified means to manage their health.

References

  1. “The Value of OTC Medicines – Pfizer.” https://cdn.pfizer. com/pfizercom/health/VOM_OTC.pdf. Accessed 2 Sep. 2022.

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How EDCs are Changing the Game in Clinical Research

November 16th, 2022 by

In the 1990s, electronic data capture (EDC)—or “remote data capture” as it was then known—was quite archaic. Sometimes, it was built on a client-server architecture on a standalone device instead of an everyday PC. These systems were essentially data “silos” with no ability to easily interchange data with other systems.

Click here to download this resource as a PDF

 

Today, EDCs integrate with other types of software in the eClinical spectrum, allowing for easy data transfer. It is now commonplace to quickly and reliably import electronic data from outside sources such as imaging data sources, lab reports, and electronic health records into an EDC. At the same time, the increasing popularity of open-source EDC software and independent data standards (e.g., CDISC) are further driving productivity.

With all the buzz about the latest clinical trial tools, it can be hard to keep up with the current state of data capture. Consider this your guide to all things EDC—what it is, how researchers can use it in clinical trials, its numerous benefits, and examples of how these translate into the real world.

What is electronic data capture?

What is electronic data capture? An electronic data capture (EDC) system is software used to collect, clean, transfer, process, and store data in clinical trials. EDCs are used by contract research organizations (CROs), sponsors, and sites to conduct both simple and complex clinical trials in all phases of research. By using electronic records to capture and manage data on a digital platform, trial sponsors eliminate the need for traditional paper-based data collection. They can capture data securely and expedite the research process while ensuring data reusability.

Most EDC systems today are cloud-based so users can get secure access from anywhere. These systems collect varying types of data depending on the therapeutic area related to the clinical trial. For example, the data forms used in an oncology study might include:

The benefits of EDCs in clinical trials

The benefits of EDC in clinical trials Today, clinical trials are typically expensive and time-consuming. Worse yet, they often create a burden for their participants. Trial sponsors are challenged to optimize every aspect of the research and development process to accelerate time to market, reduce the risk of failure, and retain participants along the way—all while staying on budget.

With the help of EDCs, sponsors can build clinical trials that meet the needs of regulators, payers, and participants. By using a foundational data platform that is flexible and interoperable, researchers speed up their research while lowering costs. Here’s how.

1. Incorporate real-world data (RWD) collection

An EDC solution simplifies and streamlines data collection. Once the data collection phase is complete, statistical processing can happen quickly. An EDC supports RWD collection by:

Real-life example: COVID-RED

Julius Clinical’s COVID-RED (Remote Early Detection) study used wearable sensor technology and a smartphone app to measure participant vitals and provide personalized advice to get tested for COVID-19, even before symptoms appeared. The trial sponsors knew recruiting and collecting data from their 20,000-participant target would be incredibly challenging under ordinary circumstances—it would require multiple sites, complicated administrative processes, and in-person participant visits. And with 7,000 participants from a high-risk group safety during the pandemic was an issue.

Julius Clinical partnered with Castor to build an eClinical platform to run their trial remotely from start to finish. Through Castor’s clinical trial platform, over 17,800 participants were engaged and retained remotely, while data was automatically collected from thousands of medical devices and pushed into Castor EDC. According to the team at Julius Clinical: “Castor’s infrastructure ensured we were able to effectively carry out this study while keeping administrative burden, costs, and losses in participant engagement to a minimum.”

Julius Clinical’s COVID-RED (Remote Early Detection) study

2. Directly capture global data

Clinical trials can be a global affair, with participants and researchers spread throughout the world. An EDC supports accuracy in international clinical studies through features like legible entries and automatic calculations. EDCs support global clinical trials by:

Real-life example: WHO Solidarity Trial

To combat the largest pandemic in recent history and generate sufficient evidence of the efficacy and safety of potential treatments, the World Health Organization (WHO) needed to mount a massive clinical trial.

The WHO needed a user-friendly system that they could deploy globally with 24/7 support. It needed to be advanced enough to support adaptive medication allocation and real-time reporting. Finally, offline data capture was a requirement due to unreliable internet in remote locations. The WHO approached Castor to help solve these challenges and quickly selected Castor as its sole EDC provider for the trial.

Castor quickly implemented a CRF in six languages, developed an adaptive randomization algorithm fitting WHO specifications, developed an offline capture tool for areas with poor telecom infrastructure, and provided 24/7 support.

“Launching and executing this ongoing trial is a remarkable achievement. In 6 months, the trial team accumulated information on the collective experience of more than 11,000 hospitalized patients in settings with varied and evolving standards of care.” – New England Journal of Medicine

3. Automate for the next generation of trial designs

Gone are the days of tedious manual data entry. Automation within clinical trials supports faster research and can speed up the return on investment of a trial. Automation within EDCs can benefit researchers by:

Real-life example: AusculThing

AusculThing seeks to transform the way healthcare providers detect heart murmurs by enabling them with a far more precise tool than the human ear. To train the algorithm to work more effectively, they would need to collect an enormous amount of audio and diagnosis data across 5 different sites.

The AusculThing team turned to Castor’s eSource platform, a system that would enable them to collect, capture, and process a significant amount of patient data from several sources, and feed it directly into Castor’s EDC. By the end of the trial, researchers had collected audio data recorded by a digital stethoscope and additional diagnosis info from over 1,700 patients – all without the need for manual source data verification. With data that’s healthy, integrated, and accessible through one interface, AusculThing can now train its AI algorithm much more efficiently and make considerable strides in creating an auscultation system that’s more accurate and efficient for healthcare systems worldwide.

Castor's eSource was used to connect all data sources

4. Streamline collaboration workflows

Throughout studies, trial teams, monitors, and auditors need to capture, process, and access data from anywhere, at any time. EDCs allow data can be quickly shared with relevant personnel, allowing for a seamless exchange of information by:

Real-life example: RSP Systems—Using Monitoring to Track Study Progress

Over the past few years, RSP Systems has worked to bring their GlucoBeam monitor to market as a non-invasive and convenient glucose monitoring technology for diabetes patients. To do so, they’ve conducted multiple small clinical trials testing various settings on the device to improve protocols, estimate the signal-to-noise ratio, and increase the accuracy of the measurements. But the success of their studies depended on gathering highly accurate data ready for analysis. And with multiple trials running—some multicenter—they needed a bird’s eye view of all their studies with minimal manual effort.

Using Castor EDC, RSP Systems can now seamlessly capture clinician, patient, device, and any other external data and get a complete overview of all the data linked to an individual patient. In particular, they’ve made great use of the monitoring feature in Castor EDC for a comprehensive overview of all the queries, data validations, and dropped verifications in each of their studies. They could find all the active validation fields in their study forms, reports, or surveys and easily filter by the type—Exclusion, Warning, and Message. From there, they could find out from which site the validation errors originated, compare the field values with the reference values defined during the validation setup, and jump to the step with the validation errors.

Woman Testing Glucose Level With Continuous Glucose Monitor

5. Manage mid-study changes with ease

EDC systems are flexible and adjustable, helping to meet the needs of the study as they change throughout the process. They support mid-study changes by:

Real-life example: AKRN Scientific Consulting

AKRN Scientific Consulting joined forces with a medical device manufacturer to innovate a way to keep a donor heart oxygenated in transport to its recipient. Together, they designed a clinical study to test their transportation solution. They then partnered with Castor to help design a clinical research ecosystem that would keep up with the evolving needs of the study.

As the randomized clinical trial expanded into several sites in different countries, study managers wanted to incorporate feedback from various study monitors and participants while still accommodating the varied regulatory and clinical needs. The protocol needed to be a living document that could evolve, reflecting the advice and parameters of each site. Fortunately, Castor’s eCRF made this possible, allowing changes to be quickly programmed and automatically uploaded to each site. As a result, each site always had the most up-to-date version of the eCRF.

What features should you look for in an EDC?

While purchasing a robust EDC may seem like a significant investment, the money that it saves, in the long run, makes it well worth the expense. Here’s what to look for:

How EDCs are Part of a Paradigm Shift within Clinical Research

Currently, clinical trials use isolated technology tools—such as eCRFs—to collect, manage, and analyze data. eCRFs are study forms built into EDCs that let researchers and clinical staff enter data directly into the system. These digital, typically web-based questionnaires ensure data compliance with privacy, security, and Good Clinical Practice regulations. Researchers can tailor eCRFs to fit each study, saving time and money.

While eCRFs may seem progressive compared to paper-based data entry, they represent a siloed system where data is entered and processed separately. They are a holdover on the way to a seamless, single platform. So what’s the broader solution?

The clinical trial industry is shifting from siloed, cumbersome processes to fully connected, interoperable clinical trial platforms for collecting and analyzing data. To do so, the trial tech community is laying the groundwork for a new way of running clinical trials: pairing an EDC with fully decentralized clinical trial (DCT) technology. By fully leveraging automation and interoperability, this innovative paradigm puts all data management components into a single system.

The CDMS/DCT combination incorporates all clinical trial data components, from electronic consent (eConsent) forms to scheduling, televisits, and data from devices, consumer wearables, and patient apps. CDMS/DCT has the potential to import real-world data (RWD), label electronic source (eSource) data, and conduct automated edit checks to ensure the quality of the data. An API architecture setup allows data collection from almost any source at lightning speed. The goal is simple: a single system to collect, store, and process all clinical trial data.

Despite all the flux within the clinical trial industry, one thing is sure: therapy breakthroughs happen faster and more often when researchers have access to affordable, user-friendly, and compliant data solutions. The good news? In just a few clicks, researchers can build a study with Castor’s data platform—without any prior technical knowledge. Better yet, they can grow alongside Castor as they step into the future of fully integrated trials.

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Essential Guide to Electronic Data Capture (EDC) in Clinical Trials

May 2nd, 2019 by

Electronic data capture (EDC) systems have become important tools for academic, medical device, biotech and pharmaceutical research. If you are a medical researcher but aren’t yet familiar with the concept of electronic data capture, here is a guide to EDC, its use in clinical trials, and how it can greatly benefit your research.

Electronic Data Capture Clinical Trials Guide Screen

Let’s begin with a quick overview of EDC.

What is Electronic Data Capture?

In a nutshell, electronic data capture (EDC) is a system of capturing and managing clinical trial data on a digital platform to replace traditional paper-based data capture. Using such a system not only lets you capture data securely but also expedites the research process and ensures data reusability. Most EDC systems nowadays are cloud-based, ensuring secure access from anywhere.

When researchers conduct a clinical study, they collect information about their patients using Case Report Forms (CRFs). For example, a diabetes study with a demographics form and a lab result form.

CRFs are traditionally paper-based, and when the study is completed, the CRF documents are gathered and sent to the sponsor, who then transfers the data to a statistical analysis tool. Not only is this a lot of manual work, but also a LOT of paper, and in some cases this paper must be stored for 15 years!

However, by using an electronic data capture system, these Case Report Forms are filled out on a web-based platform, and the data is stored directly in a central database. This saves the hassle and risks of storing potentially sensitive data on paper, Excel, and other less secure and non-reusable methods. An electronic data capture system helps ensure compliance with medical data privacy, security, and Good Clinical Practice regulations. Furthermore, most professional EDC systems today provide automatic identification of data errors. This helps the Monitors to ensure the highest data quality. This process significantly improves the quality of the data and decreases the time needed for data review and corrections.

For example, Castor’s cloud-based EDC system enables researchers to easily capture high quality, reusable data. It is tailored specifically for use in academic, medical device, biotech, and pharmaceutical research, and compliant with patient data privacy laws and GCP.

So what features should you look for in an EDC and how does this work in practice? Read on to learn how 5 organizations benefited from using Castor EDC for their medical research.

What features should you look for in an EDC?

  1. A user-friendly interface, designed to meet the specific needs of medical researchers
  2. A user-access controlled platform that facilitates collaboration among multiple sites and researchers around the world
  3. The ability to set data limits for all captured data to reduce human error
  4. Assured compliance with privacy and data protection policies, ensuring that mandatory regulations are met and that research data is collected and maintained
  5. Seamless integration with existing tools, wearables, legacy systems, and other technology
  6. The ability to reuse research data for the initial research team, the statistical analysis team, and any future users of the data
  7. Access to proactive support and technical advisors to help set up your clinical trials

What are the benefits of using Electronic Data Capture?

Here’s how 5 organizations benefited from using an electronic data capture system for their medical research.

EDC benefit #1: Ease of set up

Setting up a complete clinical study in an EDC system can be relatively easy, depending on the system you choose. For example, Castor EDC’s user interface is designed to be intuitive and researcher-friendly. Castor’s online video training, monthly webinars, and prompt customer service make setting up your study very simple. For more complex studies, one of our clinical study experts can provide assistance.

Why Iantech Inc chose Castor to conduct their medical device randomized controlled trial.

Iantech Inc is a medical device company that performed a clinical study on a minimally invasive technique for the removal of cataracts. The study included 150 subjects and was concluded in only two surgery days. The Iantech team was impressed with how comprehensive and complete Castor EDC was for their company. Within a few days after the study protocol was finalized, they were able to use Castor and enable a fully operational research base and data set. All this at only a fraction of the cost of other systems offering similar functions.

Case Study Graphic - Iantech

EDC benefit #2: Easy & secure access

One of the main benefits of using a cloud-based EDC system is that it makes collaborating with researchers from across the world easy and more importantly, secure. It allows researchers to set up a study online and simply invite other collaborators via a web link. Collaborators can access the study with a single click and without any paper. In addition, the principal investigator (PI) can set different permissions depending on the collaborator’s role.

Why Ghent University Hospital used Castor to capture data from 150 centers across the world.

The DIANA Study is an international study on antibiotic use, initiated by Ghent University Hospital in Belgium. It includes a thorough 436 page CRF, incorporating data from 150 different centers across Europe, Asia, Australia, and the Americas. Without a cloud-based solution, such a global study would have been impossible.

“Without Castor EDC, we would never have been able to collect such a large amount of data across all centers with the limited amount of local funding they received. And a paper CRF of this length would certainly not have been manageable.”
– Dr. De Waele, Ghent University Hospital in Belgium

EDC benefit #3: Capture high-quality data

A major benefit of using an EDC system is that it allows researchers to add dependencies and validations to the research forms prior to data collection, significantly improving data quality. This ensures that the data collected is accurate, flagging errors or results falling out of predetermined parameters. For example, when collecting data on subjects’ blood pressure, the PI can set parameters ensuring that only realistic data can be added, significantly reducing the possibility of human error in data entry.

Why ClinFlows used a single electronic data capture system for all researchers to capture high-quality data.

INTRAGO II is a two-year global investigator-initiated study on the use of radiotherapy during brain tumor surgery. The study included data from centers in Germany, Australia, Canada, Peru, Spain, and the United States. The study needed to be accessed by all global participants and there was a limited budget for monitoring. For this reason, clinical services company ClinFlows carefully built multivariate validations and dependencies across their forms using Castor. This guaranteed data quality and significantly reduced the cost of data corrections after the study.

EDC benefit #4: Reduction in time and cost

Why PrevER Trial used Castor to collect and store large datasets.

The PrevER trial investigated the prevalence of Hepatitis C in visitors to the emergency department at Ziekenhuis Oost Limburg. Given a large number of inclusions (3000) and sensitive patient data, initiator Dr. Rob Bielen remarked –

“Had we used Microsoft Excel and Access, it not only would have been impossible to comply with all the data protection requirements, but such a large dataset would have taken days to prepare for analysis.”
– Dr. Rob Bielen, Hasselt University/Ziekenhuis Oost Limburg Genk

EDC benefit #5: Data can be reused for future research

After publication of the study results, most datasets end up in a drawer and forgotten. When using an EDC system such as Castor, all data is stored in a central database in a standardized format. This allows researchers and their colleagues to easily reuse the data for replication and meta-analyses, to combine datasets, and to test completely new hypotheses.

An electronic data capture platform enables researchers to collect all the study data in one place, whether related to primary or secondary outcomes, patient-reported outcomes, or safety-related data. This includes electronic Case Report Forms (eCRF), electronic Patient Reported Outcomes (ePRO), electronic Clinical Outcome Assessments (eCOA), and Serious Adverse Events (SAE). Castor EDC also helps researchers to easily import legacy data or connect it to other systems (CMS, QMS, device software) through an API.

Additionally, when performing multiple post-market studies with similar end-points, using a single EDC makes it easy to reuse study setups and eCRFs.

EDC benefit #6 Compliance

One of the principal reasons for researchers to switch to an EDC system is compliance. Clinical research is highly regulated, and data, identity, and privacy regulations are becoming increasingly strict.

When capturing data using paper, Microsoft Excel, Microsoft Access, Google Forms or SPSS, it is virtually impossible to comply with all mandatory regulations which exist to protect sensitive medical data. Using a single platform for data management is critical to ensure ICH-E6 – Good Clinical Practice (GCP) and General Data Protection Regulation (GDPR) compliance. Audit trails, user access rights, and data encryption are almost impossible to control using paper copies, Excel, or other legacy systems. For example, GCP requires researchers to keep an audit trail, tracking changes in the data.

In addition, patient data needs to remain unidentifiable and secure. Papers need to be transported and Excel files can be copied and stored on a personal computer, posing major security risks. It is advisable to invest in an EDC system that allows for on-demand data access and reporting for different uses while offering meticulous data security and automatic backups. Castor EDC offers this to its users, complies with GCP and GDPR and has all relevant ISO certifications.

How AMC used Castor to become a leader in data security and compliance.

The Department of Anesthesiology in the Academic Medical Center (AMC) in Amsterdam conducts several research studies. Many were still performed using Microsoft Excel, Google Sheets and Google Forms, a process that was error prone and carried the risk of data leakage. To address this, they secured a department-wide license with Castor EDC, helping to ensure Good Clinical Practice and compliance with patient data privacy laws. They now have a much better overview of the trials running in their department, and significantly reduced their liability risk.

Interested in learning more?

Electronic data capture systems have become essential tools for contract research organizations (CROs), academic researchers as well as medical device, biotech and pharma companies. Globalization and advances in worldwide collaboration in medicine mean that researchers lagging behind in usage of this technology might find it increasingly difficult to keep up.

Castor EDC offers a user-friendly, affordable, and compliant solution for academic researchers and commercial companies. Without having prior technical knowledge, researchers can build a study in just a few clicks using the intuitive Form Builder (simply define the data fields and start collecting high-quality data!). Plus, Castor’s world-class support team is available when you need them.

 

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AKRN creates the ideal case report form using Castor EDC

October 12th, 2022 by

This is the second of three case studies covered in a webinar Castor held with AKRN Scientific Consulting. Watch the webinar for more insights from the AKRN team. You can also download this case study below.

Click here to download this case study as a PDF

 

Pulmonary vein isolation (PVI) is a procedure that can block irregular electrical signals in patients with atrial fibrillation (AF) and other heart conditions, and make that patient’s heart beat normally. However, there are significant limitations to measuring the success of this treatment and optimizing how effective it is. This is largely due to the fact that there are many diverse PVI methodologies returning disparate and inconclusive data. According to the limited study data available, success rates for PVI after 3-5 years sit at only 30-50%.1

AKRN creates the ideal case report form using Castor EDC To combat the ambiguity of PVI, a digital health company, Company Y, developed a solution that’s revolutionizing the way that we measure this data and determine how effective the procedure is. With their innovative AI algorithm, Company Y can measure the success rate of PVI, begin making improvements to this largely unreliable procedure, and start improving long- term quality of life for patients with chronic heart conditions.

Although, proving the effectiveness of this AI algorithm would be challenging — Company Y needed to collect and standardize complex PVI data across four sites, with limited time to visit each site. It was essential for their team to have a straightforward, yet comprehensive eCRF form to collect the data they need in this short amount of time.

Challenge:
Capturing complex, unstructured data

With the support of their partners AKRN Scientific Consulting, a medical device CRO based in Europe, Company Y would be equipped with the infrastructure and expertise needed to solve this data capture challenge and prove the efficacy of their tech in a clinical setting. A study of 100 participants, separated into four sites in Belgium and France, would determine whether their AI algorithm was an effective tool for monitoring patients’ PVI procedures.

Researchers from AKRN and Company Y faced the challenge of capturing complex PVI data in a standardized format. Even with modern advancements, it remains complicated to capture every detail you might need in a traditional clinical trial case report form (CRF) and gain regulatory approval from investigators.

At the sites, clinicians didn’t have the time to fill out long forms with multiple dependencies, as it was impractical in the limited time during site visits. They needed an electronic CRF simple enough that clinicians could easily understand and enter data to hold all the PVI analyzer results, yet comprehensive enough to capture all data fields needed for regulatory approval, including:

Solution:
Streamlining case report form (CRF) entry

AKRN’s team of clinical trial experts chose Castor EDC for a simplified, standardized way to collect PVI data and measure success rates. Partnered with Castor, AKRN would be equipped with an eCRF that was easy to use, efficient, and effective; enabling providers to quickly and systematically capture data at each site. Some of the benefits from using Castor’s eCRF included:

 

“They decided they wanted to have just a simple eCRF—with a simple feature that was easy to use. It had a quick overview of what was happening and the status of everything and just a repository instead of having a lengthy eCRF that doubles the information they already have.”

– Iñigo Marquet De Solís, Clinical Research Scientist & Data Manager, AKRN By Namsa

Conclusion:
Striving for better PVI success rates

AKRN and Company Y were able to complete their 100-person study in nine months to help test the effectiveness of their PVI analyzer in confirming PVI results. Collecting study data with Castor’s eCRF was easy for clinicians— reducing the burden of conducting this study in a fast-paced environment and expediting a process that would normally be lengthy and cumbersome. As a result, Company Y and AKRN are on the path to finally deliver an accurate, standardized, and seamless way to measure the long-term effectiveness of the PVI procedure, and provide the data needed to prompt a push for better PVI success rates.

References

  1. “Is pulmonary vein isolation still the cornerstone in atrial fibrillation ….” https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC4321067/. Accessed 30 Aug. 2022.

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AKRN handles mid-study changes in medical device clinical trials with Castor EDC

September 22nd, 2022 by

This is the first of three case studies covered in a webinar Castor held with AKRN Scientific Consulting. Watch the webinar for more insights from the AKRN team. You can also download this case study below.

Click here to download this case study as a PDF

 

Heart transplants have always had a limited shelf life. A retrieved heart has an incredibly short amount of time to make it from a donor to a recipient – in most cases, only 4 to 6 hours.1

AKRN handles mid-study changes in medical device clinical trials with Castor EDC

A medical device manufacturer, who we’ll call Company X, had an innovative idea: what if we perfused the heart (that is, kept it oxygenated) while moving it from the donor to the recipient? They developed a solution that fed oxygenated blood to the heart as it was in transit and awaiting a donor, dramatically lengthening the time a heart transplant could remain viable outside the body.

Early premarket tests with animal hearts suggest this innovative solution may be able to extend the heart transplant period from 4 hours to 24 hours – just imagine how far and wide the pool of donors can expand, and how many more lives can be saved, with 20 hours longer to transport a donor heart.

Designing a complex clinical study that can incorporate real-time feedback

Success in extending the transplant period with animal hearts inspired Company X to join forces with AKRN Scientific Consulting, a contract research organization (CRO) based in Madrid, Spain, to conduct a clinical study. Their primary goal would be to answer the question, “Will non-ischemic heart preservation prolong organ function in an adult heart transplant patient?” But designing a clinical study to test this was complex: the study would need to incorporate real-time feedback while maintaining consistent protocol amendments. Protocol amendments can reduce cycle time, difficulties recruiting study volunteers, and protocol design complexities, but they’re incredibly costly and time consuming for researchers. Implementing a single protocol amendment can take more than 2 months, and cost more than $453,000.2 It was critical that AKRN had a clinical trial platform that was quick to adapt and easy to scale as the study changed – an electronic data capture (EDC) system would be essential to ensuring that real-time modifications could be made to the research protocol with ease, and that regulatory needs were met at each site globally.

Designing a complex clinical study that can incorporate real-time feedback

 

Expanding clinical trial feedback to multiple sites with a living document

Expanding clinical trial feedback to multiple sites with a living documentAKRN Scientific Consulting partnered with Castor to help design a clinical research ecosystem that would keep up with the evolving needs of the study. As the randomized clinical trial expanded into several sites in different countries, study managers wanted to incorporate the feedback they heard from the various study monitors and participants and continue to accommodate the varied regulatory and clinical needs. The team needed a living document for the protocol to evolve and reflect the advice and parameters of each site. Castor’s electronic case report form (eCRF) made a living document possible, allowing for quick changes to be programmed, and automatically uploaded to each site.

Using a flexible eCRF to make protocol amendments with ease

Accommodating new clinical sites and new regulatory needs in each country also meant that real-time modifications would need to be made to AKRN’s reaserch protocol. Each clinical trial center responded with feedback on the trial and made suggestions, many of which were incorporated.

What could have been an arduous and painstaking task was simplified with Castor’s eCRF. With programmers ready to incorporate changes into the eCRF, the protocol changes were made and propagated to all the sites instantly. As a result, each center in the clinical trial always had the most up-to-date version of the eCRF.

“Castor is flexible enough to be used by beginners, and powerful enough for experienced clinical operations professionals.”

– Iñigo Marquet De Solís, Clinical Research Scientist & Data Manager, AKRN By Namsa

Overcoming trial complexities and developing life-saving treatments

Overcoming trial complexities and developing life-saving treatments

AKRN’s study has more than 200 participants, and with the ability to collect data and feedback from sites in real-time and amend their protocol accordingly, is quickly moving toward completion. Despite the complexity of this study and ongoing COVID-19 travel restrictions, Castor’s EDC proved both easy to use and robust.

“The Castor EDC is flexible enough to be used by beginners,” said Iñigo Marquet de Solís, Clinical Research Scientist & Data Manager, AKRN by NAMSA, “and powerful enough for experienced clinical operations professionals.”

Thanks to this innovative solution and the ability to test it in a clinical setting, a reality where human hearts can survive outside the human body for up to 24 hours, and patients who desperately need a donor heart have a far greater chance of receiving one, is within reach.

References

  1. “Matching Donors and Recipients – OrganDonor.gov.” 20 Apr. 2021, https://www.organdonor.gov/learn/process/matching. Accessed 24 Aug. 2022.
  2. “Protocol Amendments: a Costly Solution – Applied Clinical Trials.” 30 Apr. 2011, https://www.appliedclinicaltrialsonline. com/view/protocol-amendments-costly-solution. Accessed 24 Aug. 2022.

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The future of rare disease research

March 8th, 2022 by

Each rare disease research breakthrough offers the promise of a longer, better life for patients who otherwise may have no meaningful options. Because of this, patients grappling with rare diseases are unique within the world of clinical trials—they’re often highly motivated and eager to take part in research. Typically, they are more-informed about their disease than the average patient and are actively seeking out possible treatments. Fortunately, decentralized clinical trials (DCT) and FAIR data principles are well-poised to meet their needs and push research further, faster.

Accelerating recruitment

The eager willingness of rare disease patients to enroll in clinical trials can greatly alter the recruitment process. But first, they need to find out about the trial’s existence. Since traditional clinical trials relied on physicians or other healthcare professionals to spread the word, eligible patients didn’t always hear about current or upcoming clinical trials. Too often, clinical researchers had to rely on a wing and a prayer that the right patient would walk into the right doctor’s office and learn about the trial.  This slows down or even stalls out life saving research.

DCT changes the recruitment process entirely since it supports the screening and enrollment of patients from anywhere. Decentralized methods can also help rare disease researchers identify possible boluses of rare disease participants in certain areas, allowing them to decide where a research site might be most useful, if one is required. Alternatively, researchers may rely on remote nursing and nearby plasma centers to move research forward from afar. Regardless of the exact methods employed, decentralized trials are well-poised to increase access to rare disease trials for the participants who need it most.

Rare disease researchers have another trick up their sleeve to speed up recruitment: searchable data. When researchers can easily search high-quality data, they can find the people who can benefit most from a potential cure. One way to find rare disease patients is to comb through combined data from multiple sources. For example, searching disease registries can be highly effective. Using a standardized script to query across different registries in one move can simplify the process and accelerate recruitment exponentially. This can allow rare disease researchers to find an adequate sample size, despite the limited number of potential candidates.

Leveraging eConsent

Once possible participants are identified, the next hurdle is enrollment. One of the biggest challenges for clinical trial participants is the burden of travel to the site. For patients living in rural areas or with high-risk health conditions, this can make the difference of whether or not they will participate in a trial.

Fortunately, eConsent eliminates the need for patients to travel to sites to complete pre-screening questionnaires or informed consent. Instead, participants can complete these activities from their homes with the help of eConsent features such as video chat and e-signature. Language barriers or cultural issues can likewise be overcome by offering virtual support, including live translators via video chat.

Importantly, eConsent also allows for dynamic consent, so participants can retract or add new layers of consent over time. This paves the way for researchers to reuse data collected from various sources or even contact patients involved in other research projects through the applicable sponsors for research purposes.

Embracing FAIR data

Patient data registries that are findable, accessible, interoperable, and reusable (FAIR) for both humans and computers support research across multiple resources. This is especially relevant in rare disease research since data is too often scarce and scattered. When rare disease registries are created according to FAIR standards, then specific research questions can be asked across multiple registries without physically combining data.

Recently, a small group of researchers wrote about searching European Reference Networks (ERNs), made up of 24 virtual networks to search for a sample group of patients for a hypothetical vascular anomaly study.  Their project showed how researchers can combine data from various places to create an adequate sample size, regardless of a potentially small affected patient population.

Day-to-day data collection can be used for other rare disease research—but first it must be machine-readable to be valuable. For health systems in the European Union, it’s mandatory to collect data on certain rare or low-prevalence complex diseases—after all, when combined these affect the daily lives of around 30 million EU citizens. Every registry collects common data elements (e.g., gender, age of onset, diagnosis of disease, consent info), thereby creating huge machine-readable cross-registries for researchers to mine in their quest for cures. Other nations looking to create this success must prioritize interoperability and FAIR data principles in data collection to ensure precious data can be reused to accelerate future rare disease research.

The work done within the pharma industry for rare disease shines especially brightly. It promises the hope of a better life for those who need it most. Decentralized methods, such as eConsent, can support a completely remote prescreening, enrollment, and consent process. At the same time, reusable data speeds up the process of both finding potential participants and can even give researchers a jumpstart on their research.

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