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

ABSTRACT:

Background

Personalized medicine is a growing area of research which aims to tailor the treatment given to a patient according to one or more personal characteristics. These characteristics can be demographic such as age or gender, or biological such as a genetic or other biomarker. Prior to utilizing a patient's biomarker information in clinical practice, robust testing in terms of analytical validity, clinical validity and clinical utility is necessary. A number of clinical trial designs have been proposed for testing a biomarker's clinical utility, including Phase II and Phase III clinical trials which aim to test the effectiveness of a biomarker-guided approach to treatment; these designs can be broadly classified into adaptive and non-adaptive. While adaptive designs allow pla

SUBMITTER: Antoniou M 

PROVIDER: S-EPMC4766245 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature