Literature DB >> 32990148

Multiplicity issues for platform trials with a shared control arm.

Xiaofei Bai1, Qiqi Deng1, Dacheng Liu1.   

Abstract

This paper provides in-depth discussion about different types of error generated in platform trials with a common control arm, and how they compare to the ones arisen from standard independent trials. We provide our views on some of the popular "myths" associated with such design, under the frequentist framework. It is found that platform trial generally performs quite well in terms of type I error rate, false discovery rate, and power. In most cases, these operating characteristics of a platform trial are comparable to or even better than running individual trials.

Keywords:  Platform trial; false discovery rate; familywise error rate; type I error control

Year:  2020        PMID: 32990148     DOI: 10.1080/10543406.2020.1821703

Source DB:  PubMed          Journal:  J Biopharm Stat        ISSN: 1054-3406            Impact factor:   1.051


  4 in total

1.  Proof of Concept: Drug Selection? Or Dose Selection? Thoughts on Multiplicity Issues.

Authors:  Qian H Li; Qiqi Deng; Naitee Ting
Journal:  Ther Innov Regul Sci       Date:  2021-05-24       Impact factor: 1.778

2.  Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed.

Authors:  Síle F Molloy; Ian R White; Andrew J Nunn; Richard Hayes; Duolao Wang; Thomas S Harrison
Journal:  Contemp Clin Trials       Date:  2021-12-11       Impact factor: 2.226

Review 3.  Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials.

Authors:  Chengxing Cindy Lu; Xiaoyun Nicole Li; Kristine Broglio; Paul Bycott; Qi Jiang; Xiaoming Li; Anna McGlothlin; Hong Tian; Jingjing Ye
Journal:  Ther Innov Regul Sci       Date:  2021-06-23       Impact factor: 1.778

4.  Decision rules for identifying combination therapies in open-entry, randomized controlled platform trials.

Authors:  Elias Laurin Meyer; Peter Mesenbrink; Cornelia Dunger-Baldauf; Ekkehard Glimm; Yuhan Li; Franz König
Journal:  Pharm Stat       Date:  2022-01-31       Impact factor: 1.234

  4 in total

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