Advancing Health Equity: The Need for Diversity in Clinical Trials

On June 26th, the FDA issued its long-awaited draft guidance for incorporating diversity action plans in clinical research processes. For organizations seeking approval on their proposed treatments, ensuring whether baseline inclusion standards are met may soon be highly scrutinized. This shift is a major, breakthrough step toward securing the representation needed for more inclusive, widely applicable therapies.

However, implementing diversity in clinical trials shouldn’t just be a regulatory mandate: it is also a scientific and moral imperative at the cornerstone of accelerating the industry’s mission to achieve global health parity. In my experience, truly inclusive research is essential for developing treatments that leave no one behind, nurturing a safer world for everyone.

“To be truly diverse is much more than simply checking a box. Seeking representation from a diverse population is an opportunity to meet the unique needs of every potential person who may benefit from any initiative.”

The healthcare sector should consider broad representation across all demographics, including age, ethnicity, gender, geographic location, and more. By incorporating diverse perspectives, participants, and patients reflecting a variety of backgrounds, we can better understand how different groups respond to new treatments, ultimately leading to smarter, more effective and equitable healthcare solutions.

Medidata Solutions ’ Patient Insights Board, a body of eight patient advocates ( Justus Harris , Phyllisa Deroze, PhD , Mindy Cameron , Chien-Chi Huang, M.S. , Dave Bjork , Anne Marie Mercurio , Ella Balasa , and MarlaJan Wexler BSN, RN, CPN-BC ) that has been instrumental in infusing the patient voice throughout our technology, explores this subject further in their position paper.

Read the full report here.

Dive deeper into the intersection of diversity and cutting-edge clinical research technology in my upcoming LinkedIn Live with Phyllisa and Justus.