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. 2020 Apr 25:18:100568.
doi: 10.1016/j.conctc.2020.100568. eCollection 2020 Jun.

Master protocols: New directions in drug discovery

Vladimir Bogin  1
Affiliations

Master protocols: New directions in drug discovery

Vladimir Bogin. Contemp Clin Trials Commun. .

Abstract

A master protocol is a unifying study construct that includes multiple subgroups and substudies, with patients having same or different diseases and that employ one or multiple drugs to treat it. Initially designed for oncology, master protocol trials are intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure. The ability to use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple substudies, speeds up drug development and makes it more efficient. Thus, it is important for the clinical trial professionals to understand both the basic principles of master protocol trials and the way innovative trial designs are starting to change the landscape of clinical research.

Keywords: Basket design; Master protocols; Platform design; Umbrella design.

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Conflict of interest statement

The author declares that he has no competing interests.

Figures

Fig. 1
Fig. 1
Example of basket trial design.
Fig. 2
Fig. 2
Example of umbrella trial design.
Fig. 3
Fig. 3
Example of PlatformTrial design.
Fig. 4
Fig. 4
Gbm agile trial design.
Fig. 5
Fig. 5
REMAP-CAP trial design.
Fig. 6
Fig. 6
Battle-1 trial design.
See this image and copyright information in PMC

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