Diversity In Clinical Trials: A Regulatory Imperative

By Kwame Marfo, Market Strategy and Innovation Lead, Clinical Development

Over the last decade, Komodo Health found that patients of color were underrepresented in an analysis of clinical trials. As reported throughout the life sciences industry, inadequate racial and ethnic diversity in clinical trials is a long-standing problem. For oncology trials specifically, Komodo highlighted that 85% of participants over the last five years were White, while Black patient representation remained stagnant at under 7%. While the numbers are staggering, what's even more alarming is that Black patients have a higher mortality rate than any other racial or ethnic group for most cancers.

Differentials like this can cause myriad downstream effects on the biased applicability of findings and on the efficacy of treatments, potentially exacerbating the burdens placed on the most at-risk populations. To overcome these disparities in care and health outcomes, representation in clinical trials demands a comprehensive view of the patient populations that are affected by the disease being studied. Furthermore, the FDA's recent draft guidance is working to ensure more participants from underrepresented racial and ethnic populations are included in clinical trials.

With Komodo Health's help, learn how patient demographic insights can help increase representation and better assess real-world experiences and outcomes for diverse patient populations and derive even more meaningful insights about the patient journey.