FDA Urges Sponsors to Loosen Exclusion Criteria to Improve Trial Diversity

June 13, 2019

Drug sponsors should think about loosening up their exclusion criteria—especially when recruiting for later stage trials, the FDA says in a new draft guidance document.

Clinical trial recruitment rates are low, and recruitment of black and brown people is even worse. The agency says that part of the problem may be that sponsors are stuck on finding patients who only suffer from a given disease and no others. Perhaps worse, they exclude population such as elders, kids, obese (or overly thin) patients, and HIV-positive patients.

This may lead to “a failure to discover important safety information,” the agency says.

Broadening eligibility criteria “maximizes the generalizability of trial results and the ability to understand the therapy’s benefit-risk profile across the patient population likely to use the drug in clinical practice, without jeopardizing patient safety,” the draft guidance states.

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