Top 5 Insights From FDA Public Workshop To Enhance Clinical Trial Diversity

By Lya Rebelo, Manager, Product Success

The FDA recently hosted a compelling two-day workshop aligned with Section 3603 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). Central to this event was a fervent emphasis on the pivotal role of diversity in clinical trials. In a bid to elevate inclusivity, the agency spotlighted the imperative of incorporating underrepresented groups – encompassing pregnant and lactating individuals, children, the elderly, and those grappling with mental health conditions.

Underscoring the strategic significance of early planning and the expansion of eligibility criteria for clinical trials, the FDA also noted formidable challenges in data collection and standardization, particularly when dealing with sensitive information. In response to these hurdles, the FDA called for a collaborative commitment from all stakeholders involved in clinical trials, emphasizing the collective responsibility to ensure seamless execution.

Responding to this clarion call, Boehringer Ingelheim has proactively initiated the creation of new roles geared towards supporting diversity in clinical trials. Simultaneously, sponsors and Clinical Research Organizations (CROs) are anticipating further guidance from the FDA, demonstrating a keen interest in aligning with evolving standards.

Read more about how this workshop served as a poignant reminder of the critical need for diversity in patient recruitment for clinical trials and the shared commitment across the spectrum of clinical trial stakeholders to overcome these hurdles.