Operational Challenges and Solutions with Implementation of an Adaptive Seamless Phase 2/3 Study

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-func...

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Główni autorzy: Spencer, Kimberly, Colvin, Kelly, Braunecker, Brad, Brackman, Marcia, Ripley, Joyce, Hines, Paul, Skrivanek, Zachary, Gaydos, Brenda, Geiger, Mary Jane
Format: Artigo
Język:Inglês
Wydane: Diabetes Technology Society 2012
Hasła przedmiotowe:
Symposium
Dostęp online:https://ncbi.nlm.nih.gov/pmc/articles/PMC3570869/
https://ncbi.nlm.nih.gov/pubmed/23294774
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