For Consumers
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Gender and Race/Ethnicity, and Clinical Trials
- Enrollment of Women in HIV Clinical Trials
An evaluation abstract of the proportion of women enrolled in federally and privately sponsored clinical trials for HIV/AIDS therapies initiated between 1989-1994 - Investigational New Drug Applications; Proposed Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening Diseases, September 24, 1997.
FDA proposed amendments to the provisions of its regulations governing investigational new drug applications (IND's) to permit FDA to place a clinical hold on one or more studies under an IND involving a drug that is intended to treat a life-threatening disease affecting both genders and are otherwise eligible but are excluded from participation in an investigation only because of a risk or potential risk of reproductive or developmental toxicity from use of the investigational drug. - Investigational New Drug Applications; Final Rule Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening Diseases and Conditions
The Food and Drug Administration (FDA) amended the regulations governing investigational new drug applications (IND's) to permit FDA to place a clinical hold on one or more studies under an IND involving a drug that is intended to treat a life-threatening disease or condition affecting both genders. The amendments permit the agency to place a clinical hold on such studies if men or women with reproductive potential who have the disease or condition are otherwise eligible but are categorically excluded from participation solely because of a perceived risk or potential risk of reproductive or developmental toxicity from use of the investigational drug. This rule was developed in response to the past practice of excluding women with reproductive potential from early clinical trials because of a perceived risk or potential risk of reproductive or developmental toxicity. The final rule does not impose requirements to enroll or recruit a specific number of men or women with reproductive potential. - Section 115 of The Food and Drug Modernization Act (FDAMA) of 1997 prompted FDA to examine issues related to the inclusion of women and minorities in clinical trials, resulting in two informative articles entitled
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