Clarkston Shares Guest Column on FDA Guidance On Clinical Trial Participation
February 13, 2026 | Clarkston Consulting’s Brandon Miller and Hannah Yang recently shared a guest column with Clinical Leader discussing FDA guidance on clinical trial participation. This article outlines key takeaways from the FDA’s guidance, which formalizes expectations that sponsors must now operationalize. Read an excerpt below and the full article here.
FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do Now
“On December 15, 2025, the Food and Drug Administration (FDA) finalized its guidance on Enhancing Participation in Clinical Trials, formally updating expectations for enrollment and trial design. While progress has been made since the draft guidance in 2020, many gaps remain among minority populations, older adults, and patients with comorbidities. Regulatory commentary has long emphasized that traditional trial populations fail to reflect real-world patient complexity,3 creating challenges regarding generalizability and accuracy. Trial representativeness is now an enterprise challenge spanning development strategy, analytics, regulatory planning, and commercial readiness, with implications that extend beyond clinical operations.”