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. 2018 Aug 24:12:1-8.
doi: 10.1016/j.conctc.2018.08.009. eCollection 2018 Dec.

Master protocol trials in oncology: Review and new trial designs

Akihiro Hirakawa  1 , Junichi Asano  2 , Hiroyuki Sato  2 , Satoshi Teramukai  3
Affiliations

Master protocol trials in oncology: Review and new trial designs

Akihiro Hirakawa et al. Contemp Clin Trials Commun. .

Erratum in

Abstract

In oncology, next generation sequencing and comprehensive genomic profiling have enabled the detailed classification of tumors using molecular biology. However, it is unrealistic to conduct phase I-III trials according to each sub-population based on patient molecular subtypes. Common protocols that assess the combination of several molecular markers and their targeted therapies by means of multiple sub-studies are required. These protocols are called "master protocols," and are drawing attention as a next-generation clinical trial design. Recently, several reviews of clinical trials based on the master protocol design have been published, but their definitions of these such trials, including basket, umbrella, and platform trials, were not consistent. Concurrently, the acceleration of the development of new statistical designs for master protocol trials has been underway. This article provides an overview of recent reviews for master protocols, including their statistical design methodologies in Oncology. We also introduce several examples of previous and on-going master protocol trials along with their classifications by some recent studies.

Keywords: Basket; Bayesian adaptive method; Master protocol; Platform; Umbrella.

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Figures

Fig. 1
Fig. 1
Master protocol trial.
Fig. 2
Fig. 2
Basket trials.
Fig. 3
Fig. 3
Umbrella trials.
See this image and copyright information in PMC

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