Operational Challenges and Solutions with Implementation of an Adaptive Seamless Phase 2/3 Study
Kimberly A. Spencer, Kelly M. Colvin, Brad Braunecker, Marcia A. Brackman et autres
A wide variety of operational issues were encountered with the planning and implementation of an adaptive, dose-finding, seamless phase 2/3 trial for a diabetes therapeutic. Compared with a conventional design, significant upfront planning was required, as well as earlier, more integrated cross-functional …
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15 citations
Journal of Diabetes Science and Technology