14 Aug FDA draft guidance focuses on postapproval trial diversity data

By Michelle G. Sullivan, Regulatory Focus

Sponsors can employ several postmarketing strategies to beef up safety and efficacy data on populations that were under-represented in initial clinical trials of drugs and biologics, according to new draft guidance issued by the US Food and Drug Administration (FDA).

The agency’s draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products: Guidance for Industry lays out a number of pathways for obtaining these data after product approval, including single-arm trials, randomized trials, real-world data and meta-analyses that pool data extracted from other studies.

The document indicates FDA’s willingness to work with sponsors on the chronic problem of recruiting a diverse clinical trial population. Women, older adults, racial and ethnic minorities and non-heterosexual subjects are consistently under-represented in both federally and privately sponsored drug trials.

Last year, the FDA published draft guidance recommending that sponsors include a plan to increase diversity when proposing clinical trial designs for investigational products to agency reviewers. But this new guidance acknowledges that this ideal may be difficult to achieve. Read more …