Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA From 2010 to 2012.

@article{Eshera2015DemographicsOC,
  title={Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA From 2010 to 2012.},
  author={Noha Eshera and Hawi Itana and L Zhang and Greg Soon and Emmanuel Olutayo Fadiran},
  journal={American journal of therapeutics},
  year={2015},
  volume={22 6},
  pages={435-55}
}
To fully assess the safety and efficacy of therapeutics before approval, the US Food and Drug Administration (FDA) has encouraged adequate representation and assessment of demographic subgroups in clinical trials through guidance documents and regulations. This study aimed to survey the demographics of participants in pivotal clinical trials, as well as the presence of analyses by sex on efficacy and safety for FDA-approved new drug applications (NDAs) and biologics license applications (BLAs… CONTINUE READING
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