Within this Program area, the goal of the CDDB is to expand contraceptive and reproductive evaluation, by:
- Conducting epidemiological, statistical, and clinical studies for post-marketing surveillance of drugs, devices, and procedures utilized for contraception and reproductive health
- Collecting and disseminating results of research on the effects of drugs, devices, and procedures utilized for contraception and reproductive health
These two objectives are temporally related; the first supports the conduct of research, the second ensures appropriate interpretation and distribution of research findings.
Traditionally, the Branch has evaluated contraceptive methods through epidemiological studies and clinical trials. Although the contraceptive discovery and development activities of the Branch, discussed earlier, allow the detection of acute side effects, the clinical trials required for approval for U.S. marketing involve sample sizes that are too small and/or follow-up periods that are too short to detect less frequent events. Thus, the CDDB also supports Phase IV, or post-marketing studies of available contraceptive methods, devices, or drugs. Further, some associations between contraceptive methods and reproductive or other outcomes require larger populations, special populations, or longer observation periods than those presently required for marketing approval.