Literature DB >> 28178849

Adaptive designs from a Data Safety Monitoring Board perspective: Some controversies and some case studies.

Bruce W Turnbull1.   

Abstract

This article describes vignettes concerning interactions with Data Safety Monitoring Boards during the design and monitoring of some clinical trials with an adaptive design. Most reflect personal experiences by the author.

Keywords:  Adaptive design; enrichment design; flexible design; group-sequential test; multi-arm multi-stage trial; optimal design; promising zone; sample size re-estimation; seamless Phase II/III design

Mesh：

Year:  2017        PMID： 28178849     DOI： 10.1177/1740774516689261

Source DB:  PubMed          Journal:  Clin Trials        ISSN： 1740-7745            Impact factor:   2.486


  3 in total

1.  Design and implementation of an adaptive confirmatory trial in Japanese patients with palmoplantar pustulosis.

Authors:  Richuan Zheng; Yoichi M Ito; Motonari Yunoki; Kazuki Minoda; Soyoku Nobeyama
Journal:  Contemp Clin Trials Commun       Date:  2022-05-27

2.  A systematic review of the "promising zone" design.

Authors:  Julia M Edwards; Stephen J Walters; Cornelia Kunz; Steven A Julious
Journal:  Trials       Date:  2020-12-04       Impact factor: 2.279

3.  COVID-19 and the generation of novel scientific knowledge: Evidence-based decisions and data sharing.

Authors:  Lucie Perillat; Brian S Baigrie
Journal:  J Eval Clin Pract       Date:  2021-02-13       Impact factor: 2.336
  3 in total

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