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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...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2021
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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 |