A Seamless Adaptive 2-in-1 Design Expanding a Phase 2 Trial for Treatment or Dose Selection Into a Phase 3 Trial
Author:
Affiliation:
1. Data and Statistical Sciences, AbbVie Inc., North Chicago, IL;;
2. Biostatistics and Research Decision Sciences, Merck & Co., Inc., Rahway, NJ
Publisher
Informa UK Limited
Subject
Pharmaceutical Science,Statistics and Probability
Link
https://www.tandfonline.com/doi/pdf/10.1080/19466315.2021.1914717
Reference18 articles.
1. Adaptive Designs for Clinical Trials
2. A graphical approach to sequentially rejective multiple test procedures
3. A 2-in-1 adaptive phase 2/3 design for expedited oncology drug development
4. Extensions of the 2-in-1 adaptive design
5. FDA (2019), “Adaptive Designs for Clinical Trials of Drugs and Biologics,” https://www.fda.gov/media/78495/download.
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