Contraception Language in Informed Consent Forms: A Survey of Biopharmaceutical Companies

Abstract

Although contraception language is typically required in subject informed consent forms (ICFs) used in clinical trials, there are no regulatory guidelines on the type and duration of methods of contraception that should be used. The authors conducted an anonymous 3-part survey to assess what contraception language biopharmaceutical companies use in their ICFs as well as the staff composition of the companies’ pharmacovigilance teams dealing with pregnancy and lactation. The majority of the companies sponsor clinical trials involving either small molecules (drugs) or a mix of small and large (biologics) molecules. The survey showed notably different answers between companies. Also, only a few companies have staff specifically dedicated to overseeing the enrollment of women of childbearing potential and following their progress if they become pregnant. The findings from this survey indicate that there is little uniformity among biopharmaceutical companies with respect to the contraception language included in ICFs.