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Evaluation of Deviation From Planned Cohort Size and Operating Characteristics of Phase 1 Trials

IMPORTANCE: The cohort size of phase 1 clinical trials and thus the timing of the interim decisions are typically prespecified in the trial protocol. During trial implementation, however, the cohort size often deviates from the planned one, which shifts the schedule of the interims. Despite its perv...

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Detalles Bibliográficos
Autores principales: Park, Minjeong, Liu, Suyu, Yap, Timothy Anthony, Yuan, Ying
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7890531/
https://www.ncbi.nlm.nih.gov/pubmed/33595664
http://dx.doi.org/10.1001/jamanetworkopen.2020.37563