Post Clinical Trials & Research July 29, 2024 Bridging the gap: How digital solutions are improving diversity in clinical trials In recent years, the clinical trial landscape has evolved in terms of improving diversity among participants. The FDA’s recent draft guidance on Diversity Action Plans (DAPs) highlights the urgent need to ensure that all clinical trials reflect the diversity of the populations who will use the medical products. While historically, digital technology in clinical research created barriers for underrepresented populations (“digital divide”), more recent studies, including the All of Us Research Program, have shown that advancements in digital solutions can act as a bridge to include and engage more diverse populations in clinical trials. FDA’s new guidance: A step towards inclusive clinical trials Historically, clinical trials have struggled to include a broad spectrum of participants, often resulting in data that does not fully capture the effectiveness and safety of treatments across different demographics. On June 26, 2024, the FDA issued new draft guidance on Diversity Action Plans aimed at improving the enrollment of participants from underrepresented populations in clinical trials. This guidance is a crucial step in ensuring that clinical research reflects the diversity of the populations who will ultimately benefit from new medical treatments. From divide to bridge: The digital transformation For many years, digital technologies created barriers for underrepresented and underserved populations who may lack access to digital tools and resources. This divide posed significant challenges for achieving diversity in clinical trials, as these populations were excluded from participation due to technological limitations. Fortunately, the landscape is now changing. Digital health technologies are now being leveraged to bridge the gap and enhance diversity in clinical trials. Digital recruitment methods are making it easier to reach diverse participants, while remote monitoring, telehealth, and mobile health applications allow for their continued participation regardless of geographic location. The COVID-19 pandemic further accelerated this shift, demonstrating the feasibility and benefits of decentralized and hybrid clinical trial models. Success stories: Real-world applications of digital research tools All of Us Research Program: The NIH’s All of Us Research Program leverages CareEvolution®’s MyDataHelps™ to help reach over one million people from diverse backgrounds, including racial and ethnic minorities, rural residents, and those with limited access to healthcare. Using digital recruitment strategies, the program has successfully created a rich, diverse dataset recruiting over 820,000 participants with 80% of participants coming from groups that have traditionally been underrepresented in biomedical research (UBR)and roughly 45% from racial and ethnic minorities. Learn more about CareEvolution’s role in All of Us. University of Michigan: The University of Michigan’s MIPACT study, utilizes MyDataHelps to incorporate eConsent, longitudinal wearable device data, blood pressure measurements and electronic health data for a large, prospective, observational study. The digital approach has enabled the inclusion of a diverse participant pool. Of the nearly 7,000 participants, 18% were 65 or older, 17% were Black, and 17% were Asian, enhancing the study’s inclusivity and effectiveness. Learn more about the MIPACT study design. Scripps Research Digital Trials Center: Utilizing MyDataHelps for direct-to-participant recruitment, Scripps Research has been able to reach a more diverse population, including individuals from rural areas and minority communities. The Scripps Research Digital Trials Center has successfully implemented studies like DETECT-AHEAD which enrolled 450 participants with 52% from UBR communities, the PROGRESS study which enrolled 1137 participants with 49.8% from UBR communities, and the PowerMom study which has enrolled thousands of diverse participants across all 50 states using digital tools. These studies not only gathered valuable real world data but also demonstrated the potential of digital platforms to include traditionally underrepresented groups in clinical research. Learn more about our partnership with Scripps Research. Researchers from UMass Chan: Using MyDataHelps, researchers from UMass Chan addressed the research gap in rural Alabama. In a recent study, which utilized a digital approach to investigate the association between local weather conditions and physical activity and sleep, they enrolled 942 participants in rural counties of Alabama. The cohort was 70% female, and 78.7% Black, again showcasing the ability to engage communities historically underrepresented in biomedical research with a digital approach. Looking forward: The future of diverse clinical trials The future of clinical trials lies in the continued integration of digital solutions to promote diversity. While significant progress has been made, challenges remain. Ensuring equitable access to technology and addressing the digital literacy gap are crucial steps in this journey. However, the potential of digital tools to transform clinical research and make it more inclusive is immense. By leveraging advanced technologies such as MyDataHelps, clinical trials can become more accessible, comprehensive, and representative of the diverse populations that will benefit from new medical advancements. Conclusion The FDA’s recent guidance on Diversity Action Plans marks a pivotal moment in clinical research. With the right digital approach, we can transform the “digital divide” into a “digital bridge,” creating more inclusive and representative clinical trials. As we move forward, it is essential to leverage these technologies to reach and engage diverse populations, ensuring that medical advancements benefit all. By harnessing the power of digital technology, we can ensure that clinical trials are truly representative of all populations, bridging gaps and breaking down barriers along the way.
