FDA Reminds Sponsors: Develop Trial-Specific Eligibility Criteria
To improve trial diversity, sponsors should move away from eligibility criteria templates and draw up criteria specific to each trial, the FDA reminded industry last week.
“Inclusion and exclusion criteria are commonly accepted over time without clinical or scientific justification — for example, older patients and pediatric patients are often excluded from trials without any clear scientific or medical rationale,” said Jamie Gamerman, regulatory counsel for the Office of Medical Policy in the Center for Drug Evaluation and Research.
At the agency’s Regulatory Education for Industry Annual Conference last week, Gamerman referred to the November 2020 guidance on enhancing diversity in clinical trials, which recommends sponsors cut out excessively restrictive criteria where they can (CenterWatch Weekly, Nov. 16, 2020).
For example, she said, criteria can be broadened when moving from phase 2, which tends to be more restrictive, to phase 3. In addition, the guidance recommends sponsors justify all age restrictions and include pediatric and geriatric patients when appropriate.
The final guidance very briefly mentions a “plan of inclusion of clinically relevant populations” that the FDA strongly advises sponsors develop no later than the conclusion of the phase 2 meeting. This concept was detailed in the agency’s latest draft guidance on improving trial diversity, which offers recommendations for crafting an inclusion plan.
While the draft guidance would not mandate such plans, the FDA has said it will “evaluate the race and ethnicity diversity plan as an important part of the sponsor’s development program” when reviewing new drug approval applications (CenterWatch Weekly, April 18).