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NIH PROTOCOL GUIDELINES FOR WOMEN/MINORITIES IN PHASE III TRIALS

Executive Summary

NIH PROTOCOL GUIDELINES FOR WOMEN/MINORITIES IN PHASE III TRIALS would require investigators to consider the effects of Phase III trials on women and minority groups, according to guidelines announced Jan. 24 by National Institutes of Health Office of Extramural Research Acting Director Wendy Baldwin. Investigators submitting Phase III clinical trial applications must determine whether their proposed trial intervention will have "clinically important gender or race/ethnicity differences in the intervention effect," and, if so, whether women and minorities should be included in the large-scale trials.

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