Underrepresentation of women in new drug trials.

Young women serve less frequently than young men as subjects in premarketing clinical drug trials. Moral, legal, and medical implications of this underrepresentation of women are considered. Risks of medical harm to female patients can increase because medication is withheld. Also, risks of toxicity increase when women receive certain new drugs only in the postmarketing phase. Remedies to increase participation of young, nonpregnant women in clinical trials are discussed.