Basket Designs: Statistical Considerations for Oncology Trials.

ABSTRACT: Progress in the areas of genomics, disease pathways, and drug discovery has advanced into clinical and translational cancer research. The latest innovations in clinical trials have followed with master protocols, which are defined by inclusive eligibility criteria and devised to interrogate multiple therapies for a given tumor histology and/or multiple histologies for a given therapy under one protocol. The use of master protocols for oncology has become more common with the desire to improve the efficiency of clinical research and accelerate overall drug development. Basket trials have been devised to ascertain the extent to which a treatment strategy offers benefit to various patient subpopulations defined by a common molecular target. Conventionally conducted within the phase II setting

SUBMITTER: Kaizer AM 

PROVIDER: S-EPMC11637469 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature