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November 3, 2021

Contraception Requirements in Clinical Trials: Considerations From Studies on Sexually Transmitted Infections

Author Affiliations
  • 1Department of Epidemiology, University of Washington School of Public Health, Seattle
  • 2Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham
  • 3Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 4Magee-Womens Research Institute, Pittsburgh, Pennsylvania
JAMA. 2021;326(20):2007-2008. doi:10.1001/jama.2021.19473

Rigorous clinical trials are designed to ensure that study participants reflect individuals who may ultimately benefit from the treatment or intervention. Underrepresentation in trials leads to “data-free zones” in the safety and efficacy evidence base for commonly used and novel medications. This evidence gap leads to decisional uncertainty for patients, physicians and other clinicians, and regulatory bodies. Guidance from the National Institute of Allergy and Infectious Diseases from 2017 appropriately called for evidence from preclinical animal studies of reproductive toxicity to inform study eligibility requirements such as contraception.1,2

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