Diversity in Clinical Trials: A Regulatory Imperative


Inadequate racial and ethnic diversity in clinical trials is a long-standing problem that contributes to disparities in healthcare outcomes and experiences across the U.S. A recent Komodo analysis of clinical trials conducted in the last decade found that patients of color have been consistently underrepresented. In oncology trials, for instance, 85% of participants over the last five years were White, while Black patient representation remained stagnant at under 7%. This is despite the fact that Black patients have a higher mortality rate than any other racial or ethnic group for the majority of cancers. Dangerous differentials like this have 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.

Representation in clinical trials demands a comprehensive view of the patient populations that are affected by the disease being studied. Komodo has long been a vocal advocate for the carefully considered use of race and ethnicity data in the development of drugs and therapeutics to reduce disparities in care and health outcomes. We are encouraged by the FDA’s recent draft guidance to ensure more participants from underrepresented racial and ethnic populations are included in clinical trials.

Komodo is making it possible for clients to make meaningful decisions that ensure the clinical trials they run are reflective of the entire patient population, accounting for the nuanced patient journeys of historically underrepresented racial and ethnic groups. With the integration of expansive race and ethnicity data, our Healthcare Map is the most comprehensive source of U.S. patient-level health data available. By linking race and ethnicity data with de-identified patient data, we can better assess real-world experiences and outcomes for diverse patient populations and derive even more meaningful insights about the patient journey.BLOG FDA Guidance on R&E Data  _0422-1
Powered by the real-world evidence in Komodo’s Healthcare Map, clinical trials can be built to directly address the racial disparities in the healthcare system. The new FDA guidance sets clear expectations for Life Sciences teams to define enrollment goals and operational measures for underrepresented racial and ethnic participants to ensure the safety and efficacy of any treatment. Beyond the clinical trial stage, study designers are encouraged to measure impact throughout the development of the drug to ensure there are no inadvertent side effects across racial or ethnic groups. Komodo’s
technology allows Life Sciences teams to do exactly that in a seamless, non-disruptive way that can provide them with richer insights before, during, and after the clinical trial.

Whether by using real-world evidence to identify historically underrepresented patient populations and their associated healthcare providers, adopting decentralized clinical trials to improve access (geographic, transportation, time off work) for target patient populations, Komodo is helping Life Sciences teams proactively design and execute clinical trials that are representative of the patient populations they serve.

Ensuring equitable access and representation in clinical trials for all patients is intrinsically tied to our mission. Beyond race and ethnicity, we hope the industry will continue to prioritize progress in expanding diversity across other demographic categories such as sex, gender identity, socioeconomic status, disability, and comorbidity, among others. In surfacing key insights to shape the next generation of clinical trials, we can address and close gaps in care to drive meaningful outcomes and ultimately reduce the burden of disease – for all patients.

See how Komodo’s solutions can help power your next clinical trial – connect with us today.

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