To make medical research smarter and faster and build top-notch products to support decentralized clinical trials, we pay close attention to diversity & inclusion in Castor’s Product and Engineering teams. Therefore, we’re launching the Castor D&I interview series, where Castorian women in technology share their experiences and thoughts on making the workplace more inclusive.
When you were little, who did you aspire to become when you grew up?
I was going to become a Medical Doctor when I grew up, so I could heal people. I remember going to the hospital and being fascinated by the fact that people could actually solve my pain. My interest in healthcare always remained, but a new passion also came by, and it was engineering. When I had to choose the education path, I felt that the technology was more appealing and decided to take a Master’s Degree in Biomedical Engineering.
What got you interested in technology?
From a young age, I was interested in tech and how it evolved over time. I remember being a teenager and reading magazines about the newest version of laptops and updates on other technologies in the field. It is impressive what great impact technology has on so many different areas in our life!
What is it like to be a woman working in technology for you?
When I started my Master’s Degree in an Engineering School back in Portugal, there were not that many girls, but this has clearly changed over time. When I graduated, I could see more women applying, which is a positive sign. I am very proud of my career, but I struggled initially, not being taken as seriously as my male peers.
Tell us about your current role at Castor and the most exciting part of your work?
I’m a QA Tester at Castor. For me, the most exciting thing is to be part of a project that will have a real impact on people’s lives. Regarding what I do at Castor, I like to think of myself as a ‘bug hunter.’ I make sure we have the best product possible to deliver to our customers and make a bigger and better impact on the world of medical research.
Are there any initiatives at Castor which make a positive impact on the workplace being more diverse and inclusive?
I think Castor does a fantastic job in encouraging inclusion and diversity, and it’s one of the things I’ve enjoyed the most since I started to work here. There is a place for everyone and each opinion. It brings a very friendly work environment, where people are open, and everyone feels free and accepted to express their thoughts and views.
If you could look back five years and speak to your younger self, what advice about a career in technology would you give?
I think the best advice is: trust the process and trust in your competence. It’s advice for a lifetime and everyone.
To wrap things up, can you share a fun fact about yourself?
If I am too stressed about something, you can find me in the kitchen, preparing some meals. There is nothing more relaxing than cooking for me!
To make medical research smarter and faster, and build top-notch products to support decentralized clinical trials, we pay close attention to diversity & inclusion in Castor’s Product and Engineering teams. Therefore, we’re launching the Castor D&I interview series, where Castorian women in technology share their experiences and thoughts on making the workplace more inclusive.
Elena Tanturovska, QA Automation Engineer
When you were little, who did you aspire to become when you grew up?
I didn’t have an idol, but I was always impressed and proud of my aunt, how she carries herself with confidence, and how smart she is. I guess that was my goal while growing up, to be free to speak my mind, be confident in what I bring to any table, and make wise choices like her.
What got you interested in technology?
I found my true calling after I signed up for a Software Engineering Bachelor rather than continuing on the paved path from high school to become an economist. I was very interested in the studies, and that’s when a whole new world opened up for me. I tried something new, and it paid off, the best decision I ever made! I am glad my little sister follows my steps now.
What is it like to be a woman working in technology for you?
To be honest, I have never felt that my gender is the most interesting thing about me at the workplace. Working hard and striving for greatness separates a professional from the crowd, and I’ve always focused on this aspect. While owning my femininity, I haven’t been judged or promoted just because I am a woman.
It is noticeable that there are far fewer women working/studying in technology, but I also notice that this is changing year by year, and I am proud to live during this change.
When I started my studies, the gender ratio of females for this specialization was 10%, and that number went down by the time I graduated. In comparison, my sister is currently a part of the 40% of women studying engineering in her university. Women are detail-oriented, and we need more of that!
What is your current role at Castor, and the most exciting part of your work?
I joined Castor as Quality Assurance Automation Engineer three months ago because I wanted to be a part of an organization with a great purpose. I learn so much about medical trials every day! It brings me happiness to contribute to delivering a high-quality, reliable system to be used by our customers with my expertise.
At Castor, we aim towards having a more diverse workplace. What do you think companies can do to encourage more women to choose careers in tech?
One way to encourage more women to pursue a tech career is to develop a closer working relationship between companies and academic institutions. That way, women could have a greater understanding of the variety of roles on offer if they choose to pursue a career in tech.
If you could look back five years and speak to your younger self, what advice about a career in technology would you give?
Three magic words: Go for it!
Are there any resources you use to keep updated on technology and can recommend?
I enjoy attending webinars and code talks whenever I can. Blogs, articles, conversations with my colleagues are also great resources for inspiration! Anything that sparks my curiosity is enough for me to start with my research and learn something new.
To wrap things up, can you tell us a fun fact about you?
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.
In order to have a successful clinical trial, researchers must recruit—and retain—patients. This is a struggle that researchers know well; only 1 in 20 patients who respond to a recruitment promotion complete the study, with only 1 in 5 showing up for initial screening.
Many companies are rethinking the way they attract and engage patients in an attempt to optimize outcomes in decentralized clinical trials (DCTs). In a recent webinar, Andy Lipetz, Sr. Director of CRO Partnerships at Castor, Steve Wimmer, Director of Partnerships at 1nHealth and Kamalia Sazali, Senior Product Manager at ObvioHealth, discussed how to better engage patients for better outcomes in DCTs.
About decentralized clinical trials
Historically, traditional clinical trials’ on-site participation requirement has created an access barrier for many who don’t have transportation, childcare, or who otherwise cannot travel to trial sites. The COVID-19 pandemic made it clear that this type of clinical trial was not as sustainable as it was in the past.
“There was a vision for fully decentralized trials, and during the pandemic, it was necessary for patients to participate in a trial from anywhere,” Lipetz explained. “The vast majority of trials now are taking a hybrid or decentralized approach.”
Step 1: Personalize patient recruitment messaging
The first step in patient recruitment is, obviously, making people aware of the existence of any given clinical trial. Raising awareness of the trials is just one step in the process—researchers must also create an experience that patients want to participate in.
Liptez asked Wimmer and Sazali, “How do we do this? How do we encourage more people to participate in clinical trials?”
Both agreed that messaging intentionality was important. Many major pharmaceutical sponsors create well-intended messaging that makes people aware of the need for clinical trial participants, but they’re simply not meeting the potential recruits where they are or speaking to their needs.
“Most people who are on their lunch break on Instagram are not in the right headspace,” Wimmer said. “The messaging for reaching these people needs to be more about them, the patient. What’s in it for them?”
Wimmer continued by suggesting revising ad messaging from a broad approach to a more personalized one that targets people of a certain demographic or with specific conditions.
“There’s not really a demographic that you can’t find using the internet,” he said. “If we’ve managed to deploy a DCT, we have access to the entire population. We can now find the people we need for our studies and ensure we have a representative patient population.”
Attracting potential new participants shouldn’t stop at simply running an ad, however. Monitoring the comments on a study ad—and responding to those comments—helps create consumer engagement and raise both awareness and excitement about the clinical trial. When a viewer receives a reciprocal comment on an ad, they realize that there’s a person behind it—not a corporate monolith.
When taking a digital approach to patient recruitment and engagement, it’s important to be inclusive and sensitive to the needs of all age groups. Many advertisers assume elderly populations won’t be reachable by digital channels, or able to access them at all.
“In the US, 75% of the population over the age of 65 is what we would call ‘digitally addressable,’ meaning that they’re using the internet every day, which I think is surprising to some folks,” said Wimmer.
Step 2: Introduce remote components
People are understandably hesitant when it comes to adopting new technology, particularly when it comes to healthcare. That’s why clinical trial companies need to earn the trust of potential participants by making their experience smooth and burden-free.
One immediate way to improve the patient experience is to introduce remote components. When you reduce the number of times that a person has to visit a physical site, especially when they’re elderly, immuno-compromised, or chronically ill, you’re making their clinical trial experience far easier.
“With things becoming more remote,” Sazali said, “study participation becomes more convenient. It means that patients can take part in studies without it being a real inconvenience in their day-to-day lives.”
ObvioHealth recently launched a women’s health study that focused on urinary incontinence. The project was initially a hybrid study, but once the pandemic hit, it had to pivot and go fully virtual.
“The virtual site component was a real game changer. Staff were readily available to patients to answer questions via mechanisms that the patients were already using,” Sazali said.
When it comes to keeping patients engaged, she suggested that offering open chat and phone-call services can help immensely. When patients feel supported and engaged, they tend to want to continue to participate in a project.
“Reducing their burden while allowing them to feel like they’re part of a project helps make this more appealing to a potential patient”, said Sazali.
Step 3: Integrate technology to reduce site burden
Removing barriers and facilitating access for patients should be the primary focus for researchers as they look to successfully recruit and retain them for clinical trials. But making life easier for study and site teams is important, too. Enrolling and keeping patients engaged in clinical trials is also a huge pain point for researchers. An easier clinical trial experience for patients means that study teams have more time to focus on the outcomes of a trial.
“[Decentralizing clinical trials] helped us resolve issues and questions really quickly. Not having those ad hoc site visits or waiting several weeks to go to a site allowed us to be proactive in supporting patients through their journey,” said Sazali.
Utilizing technologies like eConsent can streamline the experience for everyone involved, from patients to staff. “If you can decentralize your enrollment experience,” Wimmer said, “there’s less burden on-site since everyone who shows up has already consented and enrolled before they arrive.”
When you take a fully digital approach to patient enrollment, you have control over the volume of participants coming to a site. If a clinical trial site is at capacity, you can easily turn off the collection of leads. Researchers also get the benefit of predictability. “We can tell you, with a relative degree of experience, that we can send you 20 to 30 pre-screened and pre-qualified leads per week. All you have to do is call them and schedule appointments,” Wimmer said of 1nHealth’s technology.
For both participants and researchers, communication has historically been a pain point—it can be difficult for patients to get in touch with clinical staff, and vice versa. Some worry that because clinical trial participants have increased access to staff, these technologies will actually increase the burden although Sazali hasn’t seen this trend. “It’s about being there to answer a quick question about the study or about the responsibilities that the patient has. Opening those lines of communication allows questions to be answered efficiently, sometimes through a chat, without having to schedule an ad hoc visit or a phone call.”
One major benefit of decentralized clinical trials is the sheer amount of data that becomes available to researchers. With DCTs, patients typically wear monitoring devices or take measurements themselves at home. Researchers can take that data and input it directly into the study database for remote monitoring.
“Instead of those point-in-time, at-site readings, we’re getting regular at-home readings or in some cases, continuous data,” Sazali said.
These regular readings give clinicians a more accurate picture of the study journey and how their patients are doing at home. It also gives access to an immense amount of data that wouldn’t be captured at a traditional trial site.
Step 4: Build an automated workflow
How does one go about picking the right tools for a clinical trial to ensure their processes are streamlined and integrated the way they need to be?
The panel agreed that a lot of it has to do with trial and error. Providing training on new technology that’s easy to understand and accessible can make a massive difference when someone’s deciding whether or not they want to participate in a clinical trial. It’s important to focus on creating technology solutions that actually reduce patient barriers and burdens, not compound them.
“I think the best way to create a streamlined experience for patients is to automate everything,” Wimmer added. “This might look like an online pre-screener that goes into a chat bot for follow up or automated scheduling. We must figure out how to make new tech play nice with as many systems as possible.”
Developing an automated workflow not only improves the patient experience, but is proven to deliver better outcomes, as demonstrated by the COVID-RED (Remote Early Detection Study).
This Julius Clinical and Takeda-supported decentralized trial uses an app paired with the AVA wearable to monitor changes in vitals, attempting to alert participants to possible COVID infection before they show symptoms. As a fully-remote study, participants needed to be engaged and retained remotely, while data was automatically collected from thousands of devices.
Using API connection, researchers were able to create an automated workflow that connected eConsent and EDC technology to allow for timely data insights and clear trial oversight. The result? Julius Clinical succeeded in recruiting over 17,824 participants in 15 weeks during the COVID-19 pandemic.
Step 5: Prioritize the patient
Finally, the team agreed that one of the most important things to remember is to not lose sight of who these technologies are really for—people.
“Yes, we have access to all these really great, amazing technologies, but it’s really important to not lose sight of the human component in all of this”, said Wimmer.
Imagine you are a patient participating in your first clinical trial. What factors encouraged you to join? What aspects would be burdensome? How would technology ease that burden? It’s only when we are able to fully understand the patient experience that we can begin to realize the potential of decentralized clinical research.
For more on this topic, watch the webinar Castor held with 1nHealth and ObvioHealth to hear thoughts on keeping patients engaged in today’s modern clinical trials.
When the pandemic hit, Julius Clinical was passionate to help in the global fight against COVID-19 and excited to expand on its experience with Decentralized Clinical Trials (DCT) in a real-world setting. However, the extraordinary circumstances and trial design brought new challenges to overcome.
COVID-RED (Remote Early Detection) is a fully remote clinical trial aimed at the early detection of COVID-19 infection. Implementing this study put new Decentralized Clinical Trial (DCT) methods to the test. The study leveraged wearable sensor technology and machine learning to detect changes in breathing rate, pulse, heart rate variability, perfusion, and skin temperature. Participants received the Ava bracelet, a wearable medical device, and downloaded the complementary Ava COVID- RED smartphone app each morning and received real-time alerts about a possible COVID-19 infection. This personalized digital feedback could result in the advice to get tested, even before symptoms appeared.
The COVID-RED study was not just any clinical trial. The enrollment targets were 13,000 people from the general population and an additional 7,000 from high-risk groups. Under ordinary circumstances, recruiting 20,000 participants would require multiple sites, complicated administrative processes, and in-person participant visits. Under COVID-19 restrictions, travel was discouraged if not outright prohibited. Further, high-risk participants often preferred to stay at home as much as possible, meaning a study coordinator might have needed to visit each participant to gather informed consent and instruct a (partially elderly) population in the use of a wearable device. Running the trial entirely remote was, therefore, the best option.
“When COVID 19 hit, we knew we could help. Teaming up with Castor helped to increase the probability of success.”
– Julius Clinical
Combining forces
To achieve the challenging targets, participants needed to be engaged and retained remotely, while data was automatically collected from thousands of medical devices. At the same time, researchers had to be provided with a clear oversight dashboard of the study’s progress. Because of its positive experience with Castor’s software and support in the past, Julius Clinical decided to combine forces with Castor to make the COVID-RED study a success. They adopted Castor’s eClinical suite and designed a new trial workflow:
Participants were screened via a Castor-powered registration and participant portal, where they entered their email addresses and completed a pre- screening survey to determine eligibility.
Through Castor eConsent, eligible participants read the informed consent form and signed it electronically; in case of any questions, participants could contact the COVID-RED helpdesk through email or by phone.
The participants’ consent was securely recorded and updated in Castor EDC, along with necessary personal information like address and phone number for shipping the participant study-related materials.
Once the Ava bracelet had been received, the data collection process could start.
Survey data was captured and distributed through Castor ePRO, including data on the participant’s vaccination status, exposure to infected individuals, and other medically sensitive information.
“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. More importantly, we achieved our objectives while maximizing participant safety and well-being via DCT during a global pandemic. We felt supported by the Castor team, with the Support and Success Team standing by in case we encountered issues. The simplicity of their user interface made it easy to get new study staff trained quickly.”
– Julius Clinical
Castor made it easy to scale this vital research as required while minimizing overhead. Julius Clinical succeeded in recruiting over 17,824 participants in 15 weeks during a global pandemic; this achievement would have been very challenging to accomplish without tools purpose- built for decentralized trials.
AusculThing’s AI algorithm is positioned to completely transform the way health care providers detect heart murmurs, enabling them with a far more precise tool than the human ear. Although, to train the algorithm to work more effectively, they would need to collect an enormous amount of data from over 1,700 patients across 5 sites.
Auscultation is traditionally a manual process, where a doctor, nurse or healthcare provider listens to the sounds of the body during a physical exam, and makes a recommendation or referral to a specialist based on what they hear. This process is highly subjective – what one provider hears may not be the same as another. Also, conducting an accurate auscultation reading requires years of experience, a very trained ear, and an incredible amount of skill. Inaccurate auscultation readings have the potential to completely overwhelm public healthcare systems, and even more critically, have dire consequences for patients that need specialty care.
AusculThing is a software company that’s positioned to take the subjectiveness out of auscultation, and create a standardized method for analyzing heart and lung sound readings using AI. Based on data signals, AusculThing can train their AI to detect heart murmurs with exponentially more precision than the subjective ear of a human health care provider. With an objective and accurate way for primary care providers to make referrals based on auscultation, the right patients will see heart and lung specialists and receive the timely care they need.
This AI algorithm has the potential to create incredible efficiencies for healthcare systems worldwide, but before being deployed at scale, it would need a steady and significant stream of data to become more accurate and prove its efficacy in a clinical setting.
Building an app for providers to collect data across multiple sites
AusculThing’s software processes audio recordings collected by a digital stethoscope called the ACC sensor. AusculThing built a provider-facing mobile app that would automate the collection of ACC sensor data from 5 university hospitals into one streamlined interface. Audio data recorded by the digital stethoscope and additional diagnosis info from over 1,700 patients was logged into the app by providers at each hospital, and pushed directly into Castor’s decentralized clinical data platform without the need for manual source data verification.
Navigating large data collection in a fast-paced environment
AusculThing’s platform had to be easy for providers to use. If it wasn’t, data collection wouldn’t happen – primary care providers work in a hectic, fast-paced environment where lives could be on the line. Taking measurements with old-school equipment and plugging data manually into an Excel file, all while trying to navigate this setting, would be wildly inefficient – data entry would easily get swept away and forgotten.
Using Castor was very simple for the nurses and care providers involved in AusculThing’s study. They could easily use the platform to enter diagnoses data without much training or technical knowledge. This was incredibly helpful to ensure that data entry wasn’t an added burden for healthcare providers on the frontlines.
“We try to make our data workflow from the clinical setting to us as smooth as possible. Here, Castor’s eSource played a very important role, because it provided us the possibility to program our own application with a custom user interface that’s very easy to use. Now, with Castor, there’s no barrier for using the system.”
– Martin Porkholm, Chief Information Officer, AusculThing
Creating healthy data flow with eSource
For their system to work, AusculThing would need to train their AI algorithm with an enormous amount of data. What seemed incredibly challenging – collecting audio data from 1,700 patients across 5 sites – became possible with Castor.
Castor’s eSource platform enabled AusculThing to collect, capture, and process a significant amount of patient data from several sources, scale data collection as their needs evolved, and eliminate manual source data verification. With data that’s healthy, integrated, and accessible through one interface, AusculThing can now train their AI algorithm much more efficiently, and make considerable strides in creating an auscultation system that’s more accurate and efficient for healthcare systems worldwide.
The health care technology market is growing, and fast. Experts calculate a compounded yearly growth of almost 20% and predict the value of the connected medical devices industry may increase from $30 billion (in 2021) to $100 billion by 2030 (1).
Let that last figure sink in. In less than ten years, the industry for devices that collect, track, manage and analyze data may more than triple in value.
Unfortunately, the technology researchers use to manage data collection for clinical trials has not kept pace with the industry’s rapid growth. Innovative software solutions and interoperability breakthroughs are out there, but the clinical research world has been slow to adapt (2).
Out with the old, in with the new
It is time to break away from traditional data management tools & guidelines to embrace new tech. The clinical trial industry is facing a dramatic shift from siloed, cumbersome processes to a fully connected, interoperable clinical trial platform for collecting and analyzing data.
Let’s explore where we are now and how we can bridge the gap between old, inefficient processes and a new, comprehensive way of approaching modern clinical trials (Figure 1).
What are eCRFs within the old paradigm?
The old paradigm for clinical data management has iterative steps.
For example, researchers may have to upload paper sources and enter the same data into electronic forms. Source data verification and manual edit checks ensure data is correct but take time and personnel. Double data entry and cumbersome validation procedures burden clinical trial administrative staff and physicians.
Today, clinical trials use isolated technology tools like Electronic Case Report Forms (eCRFs) to collect, manage, and analyze data. These eCRF forms are built into electronic data capture (EDC) systems that let researchers and clinical staff enter data directly into the system. Researchers can tailor eCRFs to fit each study, saving time and money.
When we consider the advantages of eCRFs, it seems crazy to think of them as outdated and put them in the same category as paper CRFs. However, that is the danger of holding on to the old ways in the ever-evolving world of clinical research tech. eCRFs are not going away, but they represent a siloed system where data is entered and processed separately. They are a holdover on the way to a seamless, single platform.
The CDMS/DCT combination incorporates all clinical trial data components, from electronic consent (eConsent) forms to scheduling, televisits, and data from medical devices 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. A single system collects, stores, and processes all clinical trial data.
Unfortunately, we’re not there yet. Clinical trial technology hasn’t progressed to the point where this combo is possible, and the research world hasn’t fully embraced new tools.
Bridging the gap
Clinical trial tech companies are moving toward the CDMS/DCT model by making the most of current tech and looking to the future. Here are four ways the community is linking old and new:
Link #1: Automated data capture
One step to a comprehensive data management solution is adopting application programming interfaces (APIs) to interact with EDCs. APIs help software systems (like electronic health record (EHR) databases at hospitals) communicate directly with EDCs. APIs may eliminate double data entry, paper uploads, and even source data verification.
APIs can also connect sensors, wearables, and medical devices to an EDC system, helping researchers collect biometric data and other digital endpoints from patients in real-time, and in a real-life setting. Wearable integration provides a better window into a patient’s health – instead of pulling a patient into an unfamiliar clinical setting to collect data, an automated data capture solution can communicate directly with technology that patients are already using in their daily lives, enabling researchers to collect more accurate data more often.
Link #2: Electronic surveys
Electronic clinical outcome assessments (eCOAs), like electronic patient-reported outcomes (ePROs), offer a streamlined solution for cumbersome and time-consuming paper uploads. Clinicians design surveys to send to patients who complete them on familiar devices. Survey results move automatically into EDCs, where clinicians can analyze them.
Link #3: Transparency
Reworking simple items such as the labeling system for software versions can ensure everyone uses the most current product. In this example, a clinical trial software company included year and month in addition to patch numbers on their labels to make it easy for customers to identify the age of their version. Transparency in details, like software versioning, is a forward-thinking step towards a more efficient way of doing things.
Link #4: Real-time reporting
Real-time reporting gives added visibility to how trials are performing as they are happening, allowing researchers to identify gaps and issues with endpoints and adapt accordingly. Currently, select clinical trial tech companies use simple real-time reporting. In the future, real-time reporting will be readily available in every aspect of a clinical trial.
How you can start creating a more cohesive clinical trial ecosystem
API and ePRO integrations, automated data capture, and software versioning help bridge the gap between old, inefficient ways of conducting clinical research and a more connected, interoperable way of collecting and analyzing clinical trial data.
Even though incorporating these virtual elements and taking the leap into digitization can feel intimidating, Castor’s solution is easy-to-use, and can act as the first building block to a more cohesive clinical trial platform for executing your studies. All you need to start a decentralized trial is technology to support consenting participants and reporting their trial data.
We can also provide eCRF design & training within this new framework, on a limited basis, from our team of experts.
Get started by scheduling a demo of Castor today, seeing how a modular EDC solution can act as your launchpad for digitization success.
Kellar E, Bronstein S, Caban A, et al. Optimizing the use of electronic data sources in clinical trials: The technology landscape. Ther Innov Regul Sci. 2017;51(5):551-567.
Post-market surveillance (also known as Post-Marketing Surveillance or PMS) refers to the requirement that manufacturers monitor their medical devices after being approved for sale and seeing in-market use. PMS is a regulatory requirement in significant markets, including the European Union (EU) and the United States (US).
Traditionally, PMS relies on reactive data gathering. Manufacturers collect and report adverse events from a device post-market, often using manual methods. These adverse events are either directly reported to the manufacturer or they could be reported to Regulatory bodies like FDA in the US (MAUDE database), MHRA in the UK, Health Canada in Canada etc. Since 2021, additional requirements are needed to earn a UKCA mark as well.
Manufacturers are obligated to investigate each medical device report (MDR) and inform the regulatory authorities within a given time period, to provide their assessment whether the MDR was a device related event. This approach continues to reassess medical device’s benefit/risk ratio as well as its safety and effectiveness in the post-market phase.
However, technological advances and increased regulatory requirements—particularly the more stringent ones included in the new European Medical Device Regulation (EU MDR)—are pushing a more proactive process. The enhanced regulatory requirements are also requiring for the post-market surveillance process to have a feedback loop with Design Quality, Clinical Evaluation and Technical Documentation to utilize real-time performance data of the device to anticipate and curtail events before they occur.
This blog provides an overview of PMS, including links to PMS resources, and examines vital PMS compliance requirements and deadlines in the EU and US.
What is post-market surveillance for medical devices?
PMS refers to monitoring a medical device post-market for safety and is part of pharmacovigilance, or drug and device safety. PMS is a critical part of a device’s lifecycle: monitoring the device in use by a larger population provides much more data and information than that collected in the clinical trial phase. This real-world evidence offers an ongoing and more complete picture of the safety and effectiveness of a device.
Collecting quality, performance, and safety data throughout a device’s lifetime helps manufacturers build a complete risk/benefit profile for their device and rapidly course-correct should any issues arise. As part of PMS, manufacturers also collect data on related devices from competitors.
These data can be collected as part of vigilance analysis – internal vigilance by manufacturer established internal databases that collect post-market customer complaints, failure analysis or adverse event reports, or external vigilance by country specific regulatory authorities medical device reports databases. The internal vigilance data is typically compared to the sales figure of the devices to continue to assess its risk/benefit ratio. EU-MDR is one of the first regulations to document expectations for reassessment of calculated risk ratios during the development of a device with real world vigilance and sales data in the post-market phase.
Systematic and periodic literature search as well as continuous monitoring through publication alerts for manufacturer’s and competitor’s devices can alert for off label use in populations and indications for which the device is not intended.
In summary, medical device manufacturers use real-world evidence from PMS to:
Detect adverse events as part of pharmacovigilance
Compare a new device’s performance against current standards of care.
Comply with regulatory requirements
Continue to monitor the safety and effectiveness of the device in the intended patient population.
How do you conduct post-market surveillance?
At a high level, manufacturers must take these steps to conduct PMS:
Develop a PMS plan, which includes an assessment of whether Post-Market Clinical Follow-up (PMCF) is required
Implement the plan
Generate PMS reports based on the findings
A PMS plan details a manufacturer’s strategy for continuously monitoring and collecting data and safety information on its device. The PMS plan is part of the device’s technical documentation and outlines the criteria for the risk/benefit assessment of the device and processes for:
Collecting and analyzing data
Following up on collected complaints
Communicating information to regulators and users
Taking corrective actions on devices
Producing a PMCF plan, or a rationale for why PMCF is not required
Reporting requirements vary by region, as seen below. Most reports typically include data analysis and a description of the corrective and preventative actions taken.
These reports are part of a device’s technical documentation, and manufacturers must update them regularly according to the relevant regulatory bodies’ timelines.
Post-market surveillance in the US and EU
Manufacturers must comply with PMS regulations for the region where they sell their devices.
US PMS Requirements
You can access the US requirements via these links to the pertinent sections of the Code of Federal Regulations (CFR) and the US Food and Drug Administration (FDA):
The FDA uses MedWatch for health care professionals and consumers to submit adverse event reports.
FDA also utilizes the MAUDE database to house medical device reports submitted to the FDA by mandatory reporters – manufacturers, importers and device user facilities and voluntary reporters such as health care professionals, patients and consumers.
In short, a device’s class determines requirements, with higher-risk devices more likely to require PMS. Class I medical devices typically do not need PMS, as they are lower risk.
European Union PMS Requirements
In the US, PMS is required only for higher-risk devices. However, in the EU, EU MDR not only mandates PMS for all devices but introduces new and expanded requirements that increase compliance efforts. Annex III of the MDR 2017/745 details the EU requirements for PMS.
Also, note that any manufacturer with a device planned for sale in the EU must prove that it has performed Post-Market Clinical Follow-Up (PMCF) plan for their medical devices or justify its omission. PMCF is one component of PMS activities, and the two main criteria for mandatory PMCF are the device’s risk and novelty. Specifically, devices with high-risk designations and those that are the first of their kind require PMCF.
The EU market also has a deadline looming, as the new EU MDR takes effect on May 26, 2021. Manufacturers should ensure that their PMS processes are fully compliant by this date.
Conclusion
With the deadline to comply with the EU MDR only a short time away, manufacturers must act quickly to understand PMS requirements and develop a plan. No matter where you are in the implementation process, working with a trusted partner with experience helping organizations with regulatory preparedness and submissions is critical. Castor is a trusted partner with deep expertise in clinical trials for the medical device market, one that can help you optimize PMS elements within EU MDR and US regulatory guidance.
Schedule a demo today and take the first step on your journey to identifying the most relevant PMS solutions and collecting the quality PMS data you need.
Despite the global trend towards cloud-based data services, many biopharmaceutical and medical devices companies continue to collect clinical trial Case Report Forms (CRFs) on paper. Although cloud-based Electronic Data Capture (EDC) systems for eCRFs have been around for over 15 years, it is estimated that between25 and 50% of new clinical studies still rely on paper.
According to a survey of biopharma executives, the main obstacles to using an EDC system are its up-front costs and security concerns. In addition, respondents cited the additional training required for personnel and the limited size of their clinical trial as arguments why they would not opt for an EDC system.
We argue that these obstacles are largely based on myths. In this article we will address the 4 largest myths of the benefits of paper-based CRF.
With drug development costs becoming higher, and medical device clinical regulations becoming more stringent, there is a strong need to reduce the cost of clinical trials. If you do not yet use an EDC system, we will aim to convince you that an EDC makes sense for your company.
Myth 1: Paper-based studies are less expensive
It is true, running a clinical study on paper does not require monthly license fees. The low upfront costs of starting a clinical study using paper alone is tempting. However, what seems inexpensive in the short term is actually more costly in the long run.Pavlovic, et al. estimate that when comparing paper with electronic case report forms, the long-term costs of using paper is 49-62% higher. This is substantial, to say the least. The primary contributor to the cost is the high error rate that follows from manuallyre-entering data collected.
Using an electronic case report form (eCRF), on the other hand, allows for the data to be entered directly into the system. It also allows for automatic data validations, which significantly reduces the potential for errors in the data. This will significantly reduce the time monitors have to spend on location reviewing data. According to a study byBanik et al. collecting data using an EDC leads to 82% less monitoring queries raised when compared with paper. In addition monitor site visits may be eliminated by 75%.
Myth 2: Clinical trial timelines cannot be reduced using software
While you would expect that clinical trial timelines are unaffected by the method of data collection, it has been shown that using an EDC can reduce trial timelines. According to this white paper, study-building and database-lock times can be reduced by 27-41% and 41-65% respectively. During the study-building phase, the time-saving benefits come primarily fromreusing existing eCRFs and study setups rather than building them from scratch. After the last patient visit, before database-lock, the data is checked for completeness by the data management team. All queries are resolved and the data is cleaned. This process leaves the statistical analysis team waiting, wasting valuable time. An EDC system on the other hand provides a clear overview of any missing data and unresolved queries. This allows management to quickly take action and electronically sign the verified record before database-lock.
Myth 3: Switching to an EDC and eCRFs will require significant training
Yes it is true, paper CRFs does not require any software training. Switching to an EDC system therefore seems like a significant time investment. However, the actual time required to train your personnel for using an EDC system is limited. While some traditional EDC systems require highly-skilled technical staff, more modern EDC systems such as Castor EDC have been built for user friendliness, automating features like User Acceptance Testing (UAT) in clinical trials. New organizations starting a clinical trial in Castor EDC require an average of 1-3 hours training. Clinicians entering data save time and typically require very little formal training. Castor EDC also offers premium support modules and study building services that reduce the burden on your organization. Castor EDC partners with clinical CRO ‘s such as Julius Clinical for additional clinical services such as study building.
Myth 4: Clinical data stored on paper is more secure
One seeming benefit of storing clinical trial data on paper is that it can be securely locked away from outside access. Paper can indeed be stored in a physical vault, but in practice its use is often far less secure than data stored in the cloud. Documents often lie around on staff desks, or end up in a briefcase. Documents also need to be physically transferred to a central location, which poses a security risk. Using a cloud-based EDC system mitigates these risks by using military-grade data security (ISO 27001, HIPAA), off-site backups, and transferring data using SSL encryption. Confidentiality is safe-guarded through flexible user management and an audit-trail. These features also enable your company to meet GCP compliance requirements for best clinical practice.
Conclusion
Overall, it is clear that the benefits of using paper over EDC do not hold up in the long run. With clinical trials becoming more expensive, companies should aim to streamline as many processes as possible. Using an EDC for collecting and storing clinical data therefore seems to be a simple choice. In particular:
Using an EDC system and eCRFs can specifically lower clinical trial costs by improving data quality and reducing monitoring costs.
Trial timelines can be shortened by reducing study-building and database-lock times.
Using a system such as Castor EDC does not require a significant time investment in formal training.
A cloud-based EDC system mitigates many security risks associated with physical paper and enables your study to become GCP compliant.