Criteria for the use of omics-based predictors in clinical trials.
Criteria for the use of omics-based predictors in clinical trials.
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作者：
一个检查表的标准，以确定准备的高通量'组学'为基础的测试，指导病人治疗的临床试验进行了讨论;该清单由美国国家癌症研究所与其他具有相关专业知识的科学家合作开发，提供了一个评估测试证据强度的框架，并概述了在临床环境中使用测试之前需要考虑的实际问题，目的是避免在临床试验中过早地推进基于omics的测试。高通量“组学”在临床医学中的潜力是巨大的，肿瘤学在采用这些技术方面处于领先地位。美国国家癌症研究所（NCI）与来自这些学科的研究人员和临床医生合作，制定了一份标准清单，可用于确定基于组学的测试是否准备好指导临床试验中的患者护理。该清单发表在《透视》专栏中，重点关注标本制备、测定、数学建模、临床试验设计、伦理学等方面的最佳实践。它将用于评估NCI赞助的临床试验的建议，其中组学测试指导治疗。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，开发了一个标准清单，可用于确定基于组学的测试是否准备好指导临床试验中的患者护理。检查表标准涵盖与标本、测定、数学建模、临床试验设计以及伦理、法律的和监管方面有关的问题。鼓励资助机构和期刊考虑清单，他们可能会发现这对评估研究质量和证据强度很有用。该清单将用于评估NCI申办的临床试验的建议，其中组学测试将用于指导治疗。
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. 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.
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影响因子：
9.3
作者：
McShane LM;Cavenagh MM;Lively TG;Eberhard DA;Bigbee WL;Williams PM;Mesirov JP;Polley MY;Kim KY;Tricoli JV;Taylor JM;Shuman DJ;Simon RM;Doroshow JH;Conley BA
通讯作者：
Conley BA
影响因子：
5.8
作者：
Molinaro, AM;Simon, R;Pfeiffer, RM
通讯作者：
Pfeiffer, RM
影响因子：
10.3
作者：
Subramanian, Jyothi;Simon, Richard
通讯作者：
Simon, Richard
影响因子：
46.9
作者：
Shi, Leming;Reid, Laura H.;Slikker, William, Jr.
通讯作者：
Slikker, William, Jr.
影响因子：
3.4
作者：
Moore, Helen M.;Kelly, Andrea B.;Vaught, Jim
通讯作者：
Vaught, Jim