title: Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring.
abstract: The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives.
authors.affiliation: AstraZeneca, Macclesfield, United Kingdom.
authors.forename: J
authors.initials: J
authors.lastname: Stewart
authors.affiliation: Lilly Research Laboratories, Indianapolis, IN, USA.
authors.forename: W J
authors.initials: WJ
authors.lastname: Breslin
authors.affiliation: Sanofi U.S. Inc, Bridgewater, NJ, USA.
authors.forename: B K
authors.initials: BK
authors.lastname: Beyer
authors.affiliation: Bristol-Myers Squibb, New Brunswick, NJ, USA.
authors.forename: K
authors.initials: K
authors.lastname: Chadwick
authors.affiliation: Janssen R&D, Beerse, Belgium.
authors.forename: L
authors.initials: L
authors.lastname: De Schaepdrijver
authors.affiliation: AbbVie Inc, North Chicago, IL, USA.
authors.forename: M
authors.initials: M
authors.lastname: Desai
authors.affiliation: AbbVie Inc, North Chicago, IL, USA.
authors.forename: B
authors.initials: B
authors.lastname: Enright
authors.affiliation: McMaster University, Hamilton, Ontario, Canada.
authors.forename: W
authors.initials: W
authors.lastname: Foster
authors.affiliation: Celgene Corp, Summit, NJ, USA.
authors.forename: J Y
authors.initials: JY
authors.lastname: Hui
authors.affiliation: Amgen Inc, Thousand Oaks, CA, USA.
authors.forename: G J
authors.initials: GJ
authors.lastname: Moffat
authors.affiliation: AbbVie Inc, North Chicago, IL, USA.
authors.forename: B
authors.initials: B
authors.lastname: Tornesi
authors.affiliation: Federal Agency for Medicines and Health Products, Brussels, Belgium.
authors.forename: K
authors.initials: K
authors.lastname: Van Malderen
authors.affiliation: Federal Institute for Drugs and Medical Devices, Bonn, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Wiesner
authors.affiliation: ILSI-Health and Environmental Sciences Institute, Washington, DC, USA.
authors.forename: C L
authors.initials: CL
authors.lastname: Chen
keywords: clinical trials; contraception; industry approaches; informed consent