Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration.

ABSTRACT: High-throughput 'omics' technologies that generate molecular profiles for biospecimens have been extensively used in preclinical studies to reveal molecular subtypes and elucidate the biological mechanisms of disease, and in retrospective studies on clinical specimens to develop mathematical models to predict clinical endpoints. Nevertheless, the translation of these technologies into clinical tests that are useful for guiding management decisions for patients has been relatively slow. It can be difficult to determine when the body of evidence for an omics-based test is sufficiently comprehensive and reliable to support claims that it is ready for clinical use, or even that it is ready for definitive evaluation in a clinical trial in which it may be used to direct patient therapy. Reasons

SUBMITTER: McShane LM 

PROVIDER: S-EPMC3852338 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature