New Perspective Piece in Nature Digital Medicine Suggests Systematic Changes to Clinical Trial Design Are Needed for Increased Diversity and Inclusion

NEWS BRIEF: A new perspective piece published today in Nature Digital Medicinesuggests that a paradigm shift in clinical research methods is needed to successfully address the current challenges associated with clinical trial recruitment and help improve diversity and inclusion. Based on a comprehensive literature review and experience conducting over 100 clinical trials, the authors outline specific opportunities for decentralized clinical trial (DCT) approaches to improve inclusivity, as well as some of the counterintuitive challenges associated with these approaches. They conclude DCTs provide a unique opportunity to address some of the underlying barriers to representative study recruitment. They also note that technology and decentralized trials alone will not solve the lack of diversity and inclusion in clinical research. However, collaborative efforts to understand the unintended consequences DCT approaches may have on patient recruitment can play a key role in the development of industry wide best practices and ultimately influence the broader systematic change required to make a sustainable and positive impact.

Making this publication particularly timely, last month the U.S. Food and Drug Administration issued a new draft guidance calling on industry to develop plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials.

“With as few as five percent of eligible patients participating in clinical research[i], we know that traditional clinical trials are ill designed to meet the needs of many communities, and too often fail to successfully recruit patients based on race and ethnicity, socio-economic status, whether they live in rural versus urban communities, and many other factors,” said Noah Goodson, Ph.D., director, Consulting, THREAD and lead author of the paper. “Due largely to changes catalyzed by the COVID-19 pandemic, there’s been increasing interest in how DCT approaches may improve recruitment and retention of representative participant populations. We wanted to see if the data aligned with our assumptions, so we took a close look at the emerging publications and found some counterintuitive opportunities and challenges for DCT methods to engage underrepresented populations. We know decentralized approaches are only one piece of the puzzle, but the data suggest they really do impact access, particularly for historically marginalized people.”

DCTs can make trial participation more broadly accessible by removing geographical constraints, minimizing time and expense, and creating a more engaging environment for participants. However, applying strategies that aim to solve for single elements to address diversity and inclusion can present new challenges.

“Technology advances have supported great progress in medicine but alone will not address the disproportionate rates of participation that we see in clinical research,” said Jayne Morgan, M.D., cardiologist and clinical director, COVID Task Force, Piedmont Healthcare Corporation and co-author of the editorial. “We must have a patient-centric view that looks at the many intersecting factors that influence a person’s ability to participate in research. We can then apply these learnings to drive social equity and inclusion in the development of new treatments.”

The full Nature Digital Medicine Perspective, “Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion,” is available online here.

Article citation:

Goodson, N., Wicks, P., Morgan, J. et al. Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion. npj Digit. Med. 5, 58 (2022).

For more information contact:

Jennifer Cosenza

Catalytic Agency on behalf of THREAD

jennifer.cosenza@catalyticagency.com

[i] Smalley, E. Clinical trials go virtual, big pharma dives in. Nat. Biotechnol. 36, 561-562 (2018).