3:28 PM
Nov 07, 2018
 |  BC Extra  |  Politics & Policy

FDA draft guidance calls prospective meta-analyses ‘gold standard’

FDA issued draft guidance asking sponsors planning to submit meta-analyses with regulatory applications to take a prospective approach to identifying suspected therapy-related safety signals. The gold standard, the agency said, are analyses planned prior to the start of the component trials from which data will be pooled, and where the component trials were designed with the meta-analysis in mind.

Analyses of data pooled from multiple clinical trials can help FDA and trial sponsors identify safety signals that may be too rare to identify...

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