Master protocol trials in oncology: Review and new trial designs.

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

SUBMITTER: Hirakawa A 

PROVIDER: S-EPMC6120722 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature