Assessing the impact of protocol design changes on clinical trial performance.

@article{Getz2008AssessingTI,
  title={Assessing the impact of protocol design changes on clinical trial performance.},
  author={Kenneth A. Getz and Julia Wenger and Rafael A Campo and Edward S Seguine and Kenneth I. Kaitin},
  journal={American journal of therapeutics},
  year={2008},
  volume={15 5},
  pages={450-7}
}
Although it is widely acknowledged that protocol design plays a crucial role in the success of clinical research studies, how protocols have changed over time and the impact of these changes on clinical trial performance have never been quantified. To measure protocol design trends, the Tufts Center for the Study of Drug Development analyzed data on 10,038 unique phase 1-4 protocols conducted between 1999 and 2005. Tufts Center for the Study of Drug Development analyzed study conduct… CONTINUE READING
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