The methodologies of clinical trials that evaluate barrier contraceptives need to be examined because of the growing availability of emergency contraception (EC). Emergency contraceptive pills can provide an effective backup after a barrier method malfunctions or when a barrier method is not used during intercourse. This availability of EC complicates the process for determining the effectiveness of a barrier method in a clinical trial. Because of these issues, FHI organized a dialogue among a group of contraceptive researchers and regulators with two primary goals:
- To review and clarify the study design, implementation and analysis complexities that arise when barrier methods are evaluated in a setting where EC is available.
- To define better our research agenda with respect to determining the effectiveness of new barrier contraceptive methods.
The morning session was designed to lay a common foundation for the afternoon discussions. Presentations reviewed current understandings about the effectiveness of barrier methods and current U.S. Food and Drug Administration (FDA) thinking on communicating effectiveness to consumers through product labeling. Next came a summary of the availability and utilization of emergency contraception. Five presentations followed, with each focusing on experiences from recent or ongoing barrier contraceptive effectiveness trials. The last presentation of the morning summarized the types of questions that the afternoon discussion would address.
The afternoon discussion focused on five general questions about barrier contraceptive trials:
- What do we want to know about the effectiveness of barrier contraceptives?
- Should EC be provided in advance or upon request?
- How should researchers calculate study results?
- How do the studies affect product labeling?
- Is the true efficacy study a viable option for consideration?
The group appeared to reach consensus on these points:
- A measurement of the effectiveness of the barrier method alone is needed.
- EC should be provided if a woman requests it, even if she said at the beginning of a trial she would not use it.
- The true efficacy approach holds promise, although more work is needed.
The group did not reach consensus on many other questions, notably: whether to provide EC in advance or upon request during a clinical trial, how meaningful EC-adjusted estimates of effectiveness would be, and how these estimates would affect product labeling.
More than 60 people participated in the meeting, including representatives from the U.S. Agency for International Development, the FDA, the National Institutes of Health, research organizations, individual investigators, the private sector and women's groups.
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