FDA Policy on Women in Drug Trials

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Abstract
We support the general direction in which the Food and Drug Administration (FDA) is moving regarding the inclusion of fertile women in clinical trials, as outlined by Merkatz et al. (July 22 issue).1 The previous policy prohibiting women with childbearing capacity from participating in the early phases of research lacked a coherent scientific foundation. Unfortunately, no consistent, logical approach has yet been developed that adequately addresses such important matters as fetal exposure and fully informed consent. We reviewed the informed-consent documents used in 36 clinical trials focusing on AIDS. Pregnant women were generally excluded but on inconsistent grounds. Exclusion based on potential teratogenicity was vaguely defined. Specific risks, when identified, were either barely described or described in prohibitively technical language, thus precluding genuinely informed consent. Table 1 summarizes our findings.

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