The FDA’s Diversity Action Plan guidance underwent several changes in recent months—with the draft guidance taken down, restored, and then pulled again—creating uncertainty for sponsors planning Phase III and pivotal trials across all therapeutic areas. With the final guidance expected by June 26, CRO regulatory leaders reflected on how companies can manage this evolving environment. They explored:

The impact of the FDA’s changing Diversity Action Plan guidance on sponsors’ trial planning

How companies adapted strategies to maintain inclusivity goals amid shifting regulatory priorities

Broader implications for trial design, pipeline strategies, and sponsor approaches in the global drug development landscape

This episode is part 2 of 4 in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Stay tuned for the next episode, where we’ll continue exploring the key forces shaping the future of clinical trials.

Listen to part 1 here: https://insights.citeline.com/scrip/partnered-content/podcast-series-navigating-regulatory-changes-market-dynamics-cro-perspectives-on-the-future-of-clinical-trials-26Q4Q35N6BHTZGLHIKHK6V2NXY/