3 Ways that Technology Can Help Make Clinical Trials More Representative

Representation in clinical trials is a hot topic. The historical lack of representativeness and diversity in research came to greater attention recently as the world raced to develop safe vaccines that would work for everyone. Healthcare and political leaders needed to ensure that they could say with confidence that the resulting vaccines would work for everyone.

Why is it so hard to enroll inclusive groups of study participants? Clinical trial recruitment, of course, is not easy. To help improve the odds of getting enough patients, sponsors have relied heavily over the years on study sites with access to large groups of patients. This approach, however, has led to homogenous participant populations across all therapy research. These participants tend to live relatively close to major study centers – typically large healthcare systems tied to academic institutions. They are also mostly white – with one recent study noting that Caucasians make up 83% of research study enrollees. (1)

Homogenous participant populations arise due to three basic factors:

• The country a patient lives in (the same countries are often chosen due to regulatory favorability and disease prevalence)
• Where patients live in relation to study sites
• The ability of physicians and patients to learn about studies

Technology can help to overcome these challenges. Decentralized clinical trials (DCTs) and the digital approaches they employ can help bring research opportunities to a broader range of candidates. Over time, research funding has been focused on large clinical centers, resulting in an entrenched clinical trial infrastructure. DCTs allow us to operate outside of, and expand that infrastructure. Sponsors no longer need to rely solely on those participants living within reasonable proximity to traditional study sites. They can also use these tools to build awareness of research to candidates outside of typical clinical trial communications loops.

#1. DCTs Enable Remote Data Collection

To find a more diverse population of study candidates, we must search outside of the typical study center geographies. Travel for regular clinical site visits becomes more challenging with each added mile of distance. Remote data collection allows us to bring the study into the homes of potential study participants who live far away from study centers. Technology can also be used for clinician interactions through telehealth visits and easy-to-use software apps that facilitate engagement. Using DCT approaches, we can expand our recruitment reach to find more potential candidates, more quickly and meet enrollment requirements.

#2. Advanced Data-Science Helps Find Eligible Patients Wherever They Are

The ability to expand our reach also allows us to better-target representative candidates most likely to meet study eligibility criteria. By understanding patients, we can more effectively reach them and engage with them. Using technology to mine patient and consumer data, we can build highly accurate profiles of typical study patients. With this information, we can build strategies to make these candidates aware of research opportunities and shepherd them through the recruitment process. For example, a digital advertisement can be placed on a website or social media platform that our target patients tend to visit. Interested candidates can then click a link that takes them to a simple landing page where they answer a small number of questions and are connected with a study nurse for further eligibility evaluation. Tools that help reach a wider group of patients and funnel them quickly and simply through the recruitment process can be extremely beneficial for improving access and inclusion in clinical trials.

#3. Digital Tools Remove the Problem of Research-Naivete

Another issue that keeps likely qualified candidates out of clinical trials is the lack of study awareness among clinicians and healthcare sites with little to no research experience. For clinicians not linked to traditional academic centers, there has never been a process for them to be notified proactively about studies that might be good for their patients. Clinicians are important gatekeepers for many patients that enter clinical trials, and when they don’t have easy access to data regarding open studies their patients may miss out on life-changing opportunities.

Data-science is similarly useful here, as technologies can be used to comb securely through patient data and notify clinicians when their patients might be a fit for a given trial. This capability at the point of care is extremely powerful. People trust their physicians, and many might never look into the possibility of clinical trial participation without their doctor bringing it up.

Conclusion

If we are to build more inclusive research experiences, we need to increase the scope of recruitment to reach larger, more diverse groups of candidates. With digital tools and approaches, we can recruit patients where they are – either individually or through their physician. Once enrolled, remote data collection can make study participation possible for those living far away from traditional clinical sites. These tech-enabled strategies hold the potential to get more inclusive groups of patients involved in research, resulting in better access to care for all and, ultimately, better data for those developing new medical products. For more information on how THREAD can help you implement more inclusive DCT approaches, read our white paper or visit www.threadresearch.com.

Executive Director of Delivery EMEA

Sinead is a Digital Healthcare and Clinical Research Executive with a career spanning clinical care, academic research and digital health across multiple therapeutic areas including oncology, internal medicine and vaccines development. She joins THREAD with over 18 years of experience in clinical service delivery, sponsor research governance, CRO and eHealth.

(1) Deloitte. 2020. Why Improving Inclusion and Diversity in Clinical Trials Should be a Research Priority. https://www2.deloitte.com/us/en/blog/health-care-blog/2019/why-improving-inclusion-and-diversity-in-clinical-trials-should-be-a-research-priority.html