In response to the call for more sex inclusion data in drug studies, the FDA has developed  Drug Trials Snapshot a pilot project to provide information about the sex, age, race and ethnicity of clinical trial participants for a small group of recently approved drugs. In addition to information about who participates in the trial, each Snapshot also includes information on how the study was designed, results of the efficacy and safety studies and, if known, differences in efficacy and side effects among sex, race and age (referred to as subgroups).

While this is certainly an important step toward inclusion, the recently posted six examples reinforce the lack of racial minorities in all studies and the lack of women in many studies.   These drugs were approved over a two month period in 2014.  In summary, of the six examples provided:

  • All studies, except one, had more males than females in the clinical pool
  • All studies except one, reported that the drug achieved the desired response (efficacy) in both in men and women (one study showed the the drug trended in favor of females though only 23% of the study subjects were female)
  • Four studies indicated the side effect (safety) profile was similar in both sexes; one study did not evaluate safety; and one study found increased risk for women even though only 24% of the study subjects were female).
  • All studies showed a considerable lack of minority race/ethnic participants .

"‘This new report provides a clarion call to action for the scientific, medical and regulatory communities to ensure representational science, medicine and the approval process. By taking strong, decisive action today, we can be assured a healthier tomorrow for all people." says Teresa K. Woodruff, PhD, director, Women's Health Research Institute and a national leader in the movement toward sex equity in science.

 

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