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Adaptive design implementation in confirmatory trials: methods, practical considerations and case studies

  • Published:2020-11 Issue: Volume:98 Page:106096
  • ISSN:1551-7144
  • Container-title:Contemporary Clinical Trials
  • language:en
  • Short-container-title:Contemporary Clinical Trials

Author:

Li Qing,Lin Jianchang,Lin Yunzhi

Publisher

Elsevier BV

Subject

Pharmacology (medical),General Medicine

Reference72 articles.

1. Statistical design and analysis of clinical trials: principles and methods;Shih,2015

2. Sample size calculations in clinical research;Chow,2007

3. Guidance for industry: adaptive design clinical trials for drugs and biologics;Food and Drug Administration,2019

4. The adaptive biased coin design for sequential experiments;Wei;Ann. Stat.,1978

5. Adaptive design methods in clinical trials–a review;Chow;Orphanet J. Rare Dis.,2008

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1. Bayesian sequential monitoring strategies for trials of digestive cancer therapeutics;BMC Medical Research Methodology;2024-07-19

2. Adaptive designs in dermatology clinical trials: Current status and future perspectives;Journal of the European Academy of Dermatology and Venereology;2024-04-15

3. Flexible seamless 2-in-1 design with sample size adaptation;Journal of Biopharmaceutical Statistics;2024-03-29

4. Incorporating external real-world data (RWD) in confirmatory adaptive design;Journal of Biopharmaceutical Statistics;2024-03-21

5. Application of sample size re-estimation in clinical trials: A systematic review;Contemporary Clinical Trials Communications;2023-12
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