基于组学的预测因子在临床试验中的应用标准。
Criteria for the use of omics-based predictors in clinical trials.
机构信息
Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA.
出版信息
Nature. 2013 Oct 17;502(7471):317-20. doi: 10.1038/nature12564.
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.
摘要
美国国家癌症研究所（NCI）与代表与基于组学的测试开发相关的多个专业领域的科学家合作，制定了一份检查表，可用于确定基于组学的测试是否准备好用于指导临床试验中的患者护理。检查表标准涵盖与标本、检测、数学模型、临床试验设计以及伦理、法律和监管方面相关的问题。鼓励资助机构和期刊考虑使用该检查表，他们可能会发现它有助于评估研究质量和证据强度。该检查表将用于评估由 NCI 资助的临床试验的提案，其中将使用组学测试来指导治疗。
相似文献
1
Criteria for the use of omics-based predictors in clinical trials.
Nature. 2013 Oct 17;502(7471):317-20. doi: 10.1038/nature12564.
2
Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration.
BMC Med. 2013 Oct 17;11:220. doi: 10.1186/1741-7015-11-220.
3
NCI issues omics checklist for tests.
Cancer Discov. 2014 Feb;4(2):OF6. doi: 10.1158/2159-8290.CD-NB2013-157. Epub 2013 Nov 14.
4
Next steps in clinical trial redesign.
J Natl Cancer Inst. 2012 Jan 18;104(2):90-2. doi: 10.1093/jnci/djr550. Epub 2012 Jan 3.
5
A risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group.
Lancet Oncol. 2014 Apr;15(4):e184-93. doi: 10.1016/S1470-2045(13)70607-7.
6
National Cancer Institute's Precision Medicine Initiatives for the new National Clinical Trials Network.
Am Soc Clin Oncol Educ Book. 2014:71-6. doi: 10.14694/EdBook_AM.2014.34.71.
7
An overview of the NCI precision medicine trials-NCI MATCH and MPACT.
Chin Clin Oncol. 2015 Sep;4(3):31. doi: 10.3978/j.issn.2304-3865.2015.08.01.
8
Researchers push back against overhauling clinical trials.
J Natl Cancer Inst. 2014 Aug 13;106(8). doi: 10.1093/jnci/dju274. Print 2014 Aug.
9
Some Lingering Concerns about the Precision Medicine Initiative: Currents in Contemporary Bioethics.
J Law Med Ethics. 2016 Sep;44(3):520-5. doi: 10.1177/1073110516667948.
10
The future of Cochrane Neonatal.
Early Hum Dev. 2020 Nov;150:105191. doi: 10.1016/j.earlhumdev.2020.105191. Epub 2020 Sep 12.
引用本文的文献
1
Exploring the design of clinical research studies on the efficacy mechanisms in type 2 diabetes mellitus.
Front Endocrinol (Lausanne). 2024 Sep 20;15:1363877. doi: 10.3389/fendo.2024.1363877. eCollection 2024.
2
Focus on Achalasia in the Omics Era.
Int J Mol Sci. 2024 Sep 21;25(18):10148. doi: 10.3390/ijms251810148.
3
Transcript-Level Biomarkers of Early Lung Carcinogenesis in Bronchial Lesions.
Cancers (Basel). 2024 Jun 18;16(12):2260. doi: 10.3390/cancers16122260.
4
Navigating the complexities of drug development for inflammatory bowel disease.
Nat Rev Drug Discov. 2024 Jul;23(7):546-562. doi: 10.1038/s41573-024-00953-0. Epub 2024 May 22.
5
Omics-based biomarkers as useful tools in metabolic dysfunction-associated steatotic liver disease clinical practice: How far are we?
World J Gastroenterol. 2024 Apr 14;30(14):1982-1989. doi: 10.3748/wjg.v30.i14.1982.
6
A holistic approach to understanding immune-mediated inflammatory diseases: bioinformatic tools to integrate omics data.
Comput Struct Biotechnol J. 2023 Nov 28;23:96-105. doi: 10.1016/j.csbj.2023.11.045. eCollection 2024 Dec.
7
The ethical aspects of exposome research: a systematic review.
Exposome. 2023 Apr 12;3(1):osad004. doi: 10.1093/exposome/osad004.
8
Radiomics approaches to predict PD-L1 and PFS in advanced non-small cell lung patients treated with immunotherapy: a multi-institutional study.
Sci Rep. 2023 Jul 8;13(1):11065. doi: 10.1038/s41598-023-38076-y.
9
A scoping review of statistical methods in studies of biomarker-related treatment heterogeneity for breast cancer.
BMC Med Res Methodol. 2023 Jun 29;23(1):154. doi: 10.1186/s12874-023-01982-w.
10
Targeted Therapy and Personalized Medicine.
Cancer Treat Res. 2023;185:177-205. doi: 10.1007/978-3-031-27156-4_10.
本文引用的文献
1
Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration.
BMC Med. 2013 Oct 17;11:220. doi: 10.1186/1741-7015-11-220.
2
Biospecimen reporting for improved study quality (BRISQ).
Cancer Cytopathol. 2011 Apr 25;119(2):92-101. doi: 10.1002/cncy.20147. Epub 2011 Mar 22.
3
Tackling the widespread and critical impact of batch effects in high-throughput data.
Nat Rev Genet. 2010 Oct;11(10):733-9. doi: 10.1038/nrg2825. Epub 2010 Sep 14.
4
Gene expression-based prognostic signatures in lung cancer: ready for clinical use?
J Natl Cancer Inst. 2010 Apr 7;102(7):464-74. doi: 10.1093/jnci/djq025. Epub 2010 Mar 16.
5
Randomized clinical trials with biomarkers: design issues.
J Natl Cancer Inst. 2010 Feb 3;102(3):152-60. doi: 10.1093/jnci/djp477. Epub 2010 Jan 14.
6
Use of archived specimens in evaluation of prognostic and predictive biomarkers.
J Natl Cancer Inst. 2009 Nov 4;101(21):1446-52. doi: 10.1093/jnci/djp335. Epub 2009 Oct 8.
7
Critical review of published microarray studies for cancer outcome and guidelines on statistical analysis and reporting.
J Natl Cancer Inst. 2007 Jan 17;99(2):147-57. doi: 10.1093/jnci/djk018.
8
The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.
Nat Biotechnol. 2006 Sep;24(9):1151-61. doi: 10.1038/nbt1239.
9
Prediction error estimation: a comparison of resampling methods.
Bioinformatics. 2005 Aug 1;21(15):3301-7. doi: 10.1093/bioinformatics/bti499. Epub 2005 May 19.
10
Interlaboratory comparability study of cancer gene expression analysis using oligonucleotide microarrays.
Clin Cancer Res. 2005 Jan 15;11(2 Pt 1):565-72.
Zotero 插件