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# Clinical Trial Meta-Analysis Guidance Out
- URL: https://www.fdaweb.com/clinical-trial-meta-analysis-guidance-out/
- Published: 2018-11-06T12:00:00.000Z
- Updated: 2026-09-15T00:42:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142756

FDA has published a draft guidance, *Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products*, to describe the factors FDA intends to consider when evaluating the strength of evidence provided by a meta-analysis studying the safety of drugs. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM625241.pdf?ref=fdaweb.com) includes Introduction, Background and Scope, The Quality and Relevance of Candidate Trials, The Importance of Prespecification and Transparency, Statistical Methodology Considerations, Strength of Evidence and Regulatory Decisions, Examples, and References.

Commenting on the guidance, FDA commissioner **Scott Gottlieb** [said](https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm625215.htm?utm%5Fcampaign=SBIA%3A%20FDA%20releases%20Draft%20Guidance%20on%20Meta-Analyses%20of%20Randomized&utm%5Fmedium=email&utm%5Fsource=Eloqua) the agency wants to encourage more pooled studies to evaluate important safety events. “Meta-analyses can be conducted in the pre- and post-market setting, and the recommendations in this draft guidance, when finalized, will apply to both,” he said. “Sponsors apply the principles described in this draft guidance when planning and conducting a meta-analysis of randomized controlled trials to better assess the safety of a drug product.”