Patient Exclusion Analysis Coming From FDA; Changes In Trial Recruitment Could Follow

Subjects with psychiatric conditions are often excluded from trials, an agency study finds, which “doesn’t seem a good thing” to Bob Temple.

FDA has found that many clinical trials exclude people with psychiatric conditions, which is a problem given how many drugs exacerbate such conditions, Bob Temple, deputy center director for clinical science at FDA’s Center for Drug Evaluation and Research, said.

In the agency-sponsored study, “we generally found that people with co-morbidities were included,” Temple said at the recent annual meeting of the International Society for Pharmacoeconomics and Outcomes Research

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