Women in clinical studies

Most regulatory agencies now request that women be enrolled into the clinical studies as early in phase II as possible. Since thalidomide, reproduction and teratology studies have been required prior to enrollment of large numbers of women in clinical studies, in some cases, depending on the proposed indication for the drug, postmenopausal or otherwise reproductively incapable women can be enrolled. However, the timing of the enrollment of women needs to be understood well in advance so that the lack of appropriate nonclinical reports does not hinder clinical development. 

DiMasi JA, Hansen RUS, Grabowski, HG. 2003. The price of innovation new estimates of drug development costs. J. Health Econ. 22 151-158. Mastroianni AC, Faden R, Federman D (eds). (1994). Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies. Academy Press. 

Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies Academy Press. 

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