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

Nature

502,

317–320

(17 October 2013)

doi:10.1038/nature12564

Received: 23 April 2013
Accepted: 15 August 2013
Corrected online: 16 October 2013

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.

Subject terms:

Predictive markers

High-throughput ‘omics’ technologies hold great promise to provide detailed characterization of diseases to more effectively predict a patient’s clinical course or to select the most beneficial therapies (see Box 1). These technologies have been embraced enthusiastically in oncology, as the heterogeneous character of malignant diseases presents substantial challenges for cancer detection, prognosis and optimal selection of therapy. Many preclinical studies using these technologies to elucidate biological features and mechanisms have been published, and retrospective studies applying omics assays to stored human biospecimens have been conducted to develop mathematical models to predict clinical endpoints such as survival or response to therapy.