Journal Article

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

Simon, Richard M., Cavenagh, Margaret M., Doroshow, James H., McShane, Lisa M., Lively, Tracy G., Bigbee, William L., Williams, P. Mickey, Eberhard, David A., Taylor, Jeremy M. G., Mesirov, Jill P., Tricoli, James V., Kim, Kelly Y., Shuman, Deborah J., Polley, Mei-Yin C., Conley, Barbara A.

2013

Overview

A checklist of criteria to determine the readiness of high-throughput ‘omics’-based tests for guiding patient therapy in clinical trials is discussed; the checklist, developed by the US National Cancer Institute in collaboration with additional scientists with relevant expertise, provides a framework to evaluate the strength of evidence for a test and outlines practical issues to consider before using the test in a clinical setting, with an aim to avoid premature advancement of omics-based tests in clinical trials. Guidelines for clinical use of omics data The potential of high-throughput 'omics' in clinical medicine is immense, with oncology leading the way in adopting these technologies. Working with researchers and clinicians from across the spectrum of these disciplines, the US National Cancer Institute (NCI) 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. Published in this Perspective feature, the checklist focuses on best practice in specimen preparation, assays, mathematical modelling, clinical trial design, ethics and more. It will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests guide therapy. 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.

• Publisher: Nature Publishing Group UK,Nature Publishing Group
• Subject: 692/53/2423 / Biomarkers / Checklist / Clinical trials / Clinical Trials as Topic - economics / Clinical Trials as Topic - ethics / Clinical Trials as Topic - methods / Clinical Trials as Topic - standards / Evaluation Studies as Topic / Feasibility studies / Genomics - ethics / Humanities and Social Sciences / Humans / Intellectual property / Mathematical models / Medical research / Medicine, Experimental / Models, Biological / multidisciplinary / National Cancer Institute (U.S.) - economics / perspective / Precision Medicine - ethics / Precision Medicine - methods / Precision Medicine - standards / Reporting requirements / Research Design - standards / Science / Specimen Handling / Technological change / United States