The practical aspects of clinical trials of contraceptive methods.

Abstract

Although setting up a clinical trial to test the efficacy of a method of contraception may appear to be a simple exercise, in practice, unless the aim is well delineated, the trial carefully designed, and the staff participating in the trial carefully briefed, problems will arise which prevent a successful outcome. Possible areas of bias such as selection of participants and staff prejudices must be eliminated, otherwise the value of the results may be diminished. Ethical considerations must be addressed regarding voluntary participation, information for participants, delineation of risk to participants and informed consent.