Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.

ABSTRACT: Biomarker-guided treatment is a rapidly developing area of medicine, where treatment choice is personalised according to one or more of an individual's biomarker measurements. A number of biomarker-guided trial designs have been proposed in the past decade, including both adaptive and non-adaptive trial designs which test the effectiveness of a biomarker-guided approach to treatment with the aim of improving patient health. A better understanding of them is needed as challenges occur both in terms of trial design and analysis. We have undertaken a comprehensive literature review based on an in-depth search strategy with a view to providing the research community with clarity in definition, methodology and terminology of the various biomarker-guided trial designs (both adaptive and non-adap

SUBMITTER: Antoniou M 

PROVIDER: S-EPMC5374391 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature