Adaptive Signature Design- review of the biomarker guided adaptive phase -III controlled design.

ABSTRACT: Genomics having a profound impact on oncology drug development necessitates the use of genomic signatures for therapeutic strategy and emerging medicine proposals. Since its advent in the arena of clinical trials biomarker-related predictive methods for the identification and selection of patient subgroups, with optimal treatment response, are widely used. Genetic signatures which are accountable for the differential response to treatments are experimentally recognizable and analytically validated in phase II stage of clinical trials. The availability of robust and validated biomarkers in phase III is limited. Hence, the development of a clinical trial design without the availability of biomarker identity for treatment-sensitive patients becomes indispensable. Adaptive Signature Design (AS

SUBMITTER: Bhattacharyya A 

PROVIDER: S-EPMC6591770 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature