1. Criteria for the use of omics-based predictors in clinical trials
- Author
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McShane, Lisa M, Cavenagh, Margaret M, Lively, Tracy G, Eberhard, David A, Bigbee, William L, Williams, P Mickey, Mesirov, Jill P, Polley, Mei-Yin C, Kim, Kelly Y, Tricoli, James V, Taylor, Jeremy MG, Shuman, Deborah J, Simon, Richard M, Doroshow, James H, and Conley, Barbara A
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Trials and Supportive Activities ,Clinical Research ,Cancer ,Good Health and Well Being ,Checklist ,Clinical Trials as Topic ,Evaluation Studies as Topic ,Genomics ,Humans ,Models ,Biological ,National Cancer Institute (U.S.) ,Precision Medicine ,Research Design ,Specimen Handling ,United States ,General Science & Technology - 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.
- Published
- 2013