Criteria for the use of omics-based predictors in clinical trials.

Nature
Authors
Keywords
Abstract

The US National Cancer Institute (NCI), in collaboration with scientists representing multiple areas of expertise relevant to 'omics'-based test development, has developed a checklist of criteria that can be used to determine the readiness of omics-based tests for guiding patient care in clinical trials. The checklist criteria cover issues relating to specimens, assays, mathematical modelling, clinical trial design, and ethical, legal and regulatory aspects. Funding bodies and journals are encouraged to consider the checklist, which they may find useful for assessing study quality and evidence strength. The checklist will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests will be used to guide therapy.

Year of Publication
2013
Journal
Nature
Volume
502
Issue
7471
Pages
317-20
Date Published
2013 Oct 17
ISSN
1476-4687
URL
DOI
10.1038/nature12564
PubMed ID
24132288
PubMed Central ID
PMC4180668
Links
Grant list
P30 CA046592 / CA / NCI NIH HHS / United States
R01 CA129102 / CA / NCI NIH HHS / United States
Z99 CA999999 / Intramural NIH HHS / United States