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. 2022 Dec;19(6):690-696.
doi: 10.1177/17407745221110199. Epub 2022 Sep 9.

Mobilizing the clinical trial ecosystem to drive adoption of master protocols

Abby Bronson  1   2 , Marianne K Chase  3 , Kimberly Fisher  4 , Daniel Millar  4 , Jane Perlmutter  5 , Nicholas Richardson  6
Affiliations

Mobilizing the clinical trial ecosystem to drive adoption of master protocols

Abby Bronson et al. Clin Trials. 2022 Dec.

Abstract

Master protocol studies typically use an overarching protocol to answer several questions by guiding a variety of sub-studies. These sub-studies can incorporate multiple diseases, therapies, or both. Although this innovative approach offers many benefits, including the ability to deliver clinical research that is more patient-centric and efficient, several common barriers curtail widespread adoption. The Clinical Trials Transformation Initiative (CTTI) convened industry representatives, regulatory agencies, patient groups, and academic institutions to identify emerging best practices and develop resources designed to help sponsors and other stakeholders overcome these challenges. We first identify some broad changes needed in the clinical trials ecosystem to facilitate mainstream adoption of master protocol studies, and we subsequently summarize CTTI's resources designed to support this effort.

Keywords: Master protocol studies; basket trials; clinical research funding; clinical trial design; collaboration; multiple targeted therapies; patient-centric clinical trial design; platform trials; umbrella trials.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Daniel Millar and Kimberly Fisher report employment and shareholder interest in Johnson & Johnson. The other authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Pre-planning, planning, and execution stages of master protocol studies.
See this image and copyright information in PMC

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