Navigating Regulatory Uncertainty: Diversity Action Plans

Sponsors planning Phase 3 and pivotal clinical trials are facing fresh uncertainty as the FDA’s Diversity Action Plan guidance continues to shift. In response, regulatory experts from leading CROs discussed how companies can navigate this unstable environment. Key topics included the practical impact of evolving diversity expectations on trial planning, the ways sponsors have adjusted their strategies to uphold inclusivity goals despite regulatory flux, and the broader ripple effects on trial design, pipeline development, and global drug development strategies.