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Pregnant women in clinical trials: FDA questions how to include them


 

Gerald G. Briggs

Gerald G. Briggs

The draft guidance should take note of the fact that birth defects often don’t appear for months or even longer, according to Gerald Briggs, BPharm, FCCP, clinical professor of pharmacy at the University of California, San Francisco. “Until first year of life or later, the babies need to be monitored,” he said in an interview.

Mr. Briggs, who led a 2015 report examining the role of pregnant women in phase 4 clinical drug trials, added that the document should take note of recommendations from clinical teratologists regarding the design of animal studies that should be performed prior to human trials (Am J Obstet Gynecol. 2015;213(6):810-5).

Comments on the draft guidance can be made at www.federalregister.gov and are due by June 8, 2018.

Dr. Chambers and Mr. Briggs reported no relevant disclosures.

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