Criteria for the use of omics-based predictors in clinical trials
| Autor: | James H. Doroshow, William L. Bigbee, Jill P. Mesirov, Margaret M. Cavenagh, Barbara A. Conley, P. Mickey Williams, Tracy Lively, Lisa M. McShane, Deborah J. Shuman, James V. Tricoli, Jeremy M. G. Taylor, David A. Eberhard, Richard M. Simon, Kelly Y. Kim, Mei Yin C. Polley |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
Research design
medicine.medical_specialty General Science & Technology National Cancer Institute MEDLINE Models Biological Article Specimen Handling Models medicine Humans Medical physics Precision Medicine Clinical Trials as Topic Multidisciplinary Clinical study design Genomics Biological Precision medicine Omics United States National Cancer Institute (U.S.) Checklist Test (assessment) Clinical trial Research Design Evaluation Studies as Topic Psychology |
| Zdroj: | Nature, vol 502, iss 7471 Nature |
| ISSN: | 1476-4687 0028-0836 |
| DOI: | 10.1038/nature12564 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|