Publication Date:
2013-10-18
Description:
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.〈br /〉〈br /〉〈a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4180668/" target="_blank"〉〈img src="https://static.pubmed.gov/portal/portal3rc.fcgi/4089621/img/3977009" border="0"〉〈/a〉 〈a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4180668/" target="_blank"〉This paper as free author manuscript - peer-reviewed and accepted for publication〈/a〉〈br /〉〈br /〉〈span class="detail_caption"〉Notes: 〈/span〉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 M G -- Shuman, Deborah J -- Simon, Richard M -- Doroshow, James H -- Conley, Barbara A -- P30 CA046592/CA/NCI NIH HHS/ -- R01 CA129102/CA/NCI NIH HHS/ -- Z99 CA999999/Intramural NIH HHS/ -- England -- Nature. 2013 Oct 17;502(7471):317-20. doi: 10.1038/nature12564.〈br /〉〈span class="detail_caption"〉Author address: 〈/span〉Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA. mcshanel@ctep.nci.nih.gov〈br /〉〈span class="detail_caption"〉Record origin:〈/span〉 〈a href="http://www.ncbi.nlm.nih.gov/pubmed/24132288" target="_blank"〉PubMed〈/a〉
Keywords:
Checklist
;
Clinical Trials as Topic/economics/ethics/*methods/standards
;
Evaluation Studies as Topic
;
*Genomics/ethics
;
Humans
;
Models, Biological
;
National Cancer Institute (U.S.)/economics
;
Precision Medicine/ethics/methods/standards
;
*Research Design/standards
;
Specimen Handling
;
United States
Print ISSN:
0028-0836
Electronic ISSN:
1476-4687
Topics:
Biology
,
Chemistry and Pharmacology
,
Medicine
,
Natural Sciences in General
,
Physics
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