Research has shown that differences in biology and genetics may influence the efficacy of pharmaceutical treatments. If a potential compound’s performance is evaluated in a homogenous trial population, such results may not apply to a heterogeneous patient population. For example, only after it had been on the market for a number of years did the U.S. Food and Drug Administration approve a label change for the active ingredient in Ambien upon determining that women metabolize the drug more slowly than men. Despite this understanding, clinical trials today skew largely white, male and young and often fail to reflect the demographics and genetics of the ultimate recipients of the treatment.
Each of the major federal voices in regulating biomedical research has contributed to the discussion regarding the inclusion of women and minorities in clinical trials. The following briefly summarizes the existing regulatory landscape.
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