Linda Ann Sherman, Robert Temple, Ruth B. Merkatz* tion is a life-threatening illness that affects many women, making it essential that wom-en participate in trials of HIV-related drugs, these findings also suggestedthat the issue of the participation of women in clinical trials was more complex than initially realized. Persuaded that the 1977 guideline was indeed paternalistic, that studies in women of childbearing potential could be carried out without risk of fetal exposure, and firm in its commitment to promote women's health and to enhance knowledgeabout the effects of drugs in women, the FDA removed the 1977 restriction and issued a new guideline (11). Perceptions of the Guideline

Comments submitted to FDA and other publicdiscussions indicate that there is gen-eral agreement with the purpose and direc-tion of the gender guideline. There have, nonetheless, been areas of discussion and controversy. For example, because the guideline does not specify what constitutes an adequate sample of patients with the disease to be treated, nor exactly how to