Experts Ask FDA to Rethink Clinical Trial Exclusion Criteria

A panel of experts urged the FDA to reconsider rigid rules excluding certain groups from clinical trials — or at least to make decisions on a case-by-case basis.

The agency convened a roundtable to address barriers preventing some populations, including children, seniors, pregnant women and those with multiple conditions, from enrolling in clinical trials.

Its summary report suggests that ethical concerns about testing these groups may be unnecessary and may deprive trials of key critical data.

“Excluding these patients limits the ability of a trial to generate data that are relevant to the actual users of the drug and limits the ability to describe how investigational therapies affect the pathophysiology of common chronic conditions and interact with other therapies,” the report says.