Personalized Medicine: Genomics Trials in Oncology.
The era of genomics-based medicine promises to provide molecular tests that will permit precision medicine. However, in 2015, it is not clear what the terms genomics-based medicine, molecular tests, or precision medicine mean. In this report, we review the definitions of these terms and other important semantics relative to what it takes to get a tumor biomarker into standard clinical practice, and the potential clinical trial designs that are being considered to determine if tumor biomarker tests based on next-generation sequencing actually provide benefit to patients with cancer.
Ann Arbor, Michigan.
Daniel F
DF
Hayes
Ann Arbor, Michigan.
Anne F
AF
Schott
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000235:genetics*; D002986:Clinical Trials as Topic / Q000379:methods*; D020022:Genetic Predisposition to Disease; D023281:Genomics / Q000379:methods*; D006801:Humans; D008495:Medical Oncology / Q000379:methods*; D009369:Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D018579:Patient Selection; D010641:Phenotype; D057285:Precision Medicine / Q000379:methods*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor