Implications of Research Biopsies in Clinical Trials.
Implications of Research Biopsies in Clinical Trials.
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DOI：
10.1002/onco.13948
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发表时间：
2021-08
期刊：
影响因子：
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通讯作者：
S. Dermody;A. Shuman
中科院分区：
文献类型：
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作者：
S. Dermody;A. Shuman
生物样本是转化肿瘤学中无价的关键，既可以产生新的发现，也可以评估新治疗模式的疗效。此类标本的收集和使用依赖于将尸体委托给临床医生的患者和受试者。对于仅为了增强科学理解而进行的研究活检尤其如此，可能不会为个体患者或受试者带来任何益处。美国临床肿瘤学会 (ASCO) 最近制定了一个伦理框架，以改进临床试验中研究活检的采购并为其提供信息。通过考虑它们增加科学知识的潜力、收集它们的固有风险以及临床管理是否需要它们，这些指南为活检分配了加权效用[1]。尽管 ASCO 指南对于研究人员和临床医生来说都是一个很好的模型，但它们在实践中如何实施仍不确定。因此，了解这些指南并找出其使用的障碍至关重要，特别是当研究活检成为临床试验中越来越常见的组成部分时。在本期《肿瘤学家》中，奥林匹奥斯等人。审查在 ASCO 道德框架 [2] 发布之前设计的一系列临床试验中研究活检的请求和同意。值得注意的是，只有 39% 需要强制活检的临床试验符合随后发布的框架。作者评估了多项研究属性，以确定是否符合 ASCO 框架，包括活检的潜在效用、患者的风险以及活检的强制性或可选要求。对知情同意书进行了彻底分析，以了解活检风险并解释科学原理。多项研究要求进行活检以达到探索性目的。缺乏合规性的其他原因包括统计分析不充分或风险不成比例。奥林匹亚斯等人。还报告说，知情同意文件中往往没有充分描述研究活检的风险程度。这项研究强调了对当前实践进行批判性重新评估的必要性，以及我们如何才能最好地尊重和服务现有患者，同时推进必要的科学，以改善未来像他们这样的患者的护理。随着精准医学时代识别预测生物标志物的呼声日益高涨，批判性评估研究活检在临床试验中的影响至关重要。我们讨论了将研究活检纳入临床试验的风险效益分析、双临床医生研究人员固有的紧张关系，以及患者信息日益商业化时代的问题。
Biospecimens are invaluable lynchpins in translational oncology, both to engender new discoveries and to assess the efficacy of new treatment paradigms. The collection and use of such specimens rely upon the patients and subjects who entrust clinicians with their bodies. This is especially true for research biopsies that are solely performed to enhance scientific understanding and may not offer any benefit to the individual patient or subject. An ethical framework was recently developed by the American Society of Clinical Oncology (ASCO) to improve and inform the procurement of research biopsies in clinical trials. By considering their potential to increase scientific knowledge, the inherent risk of their collection, and whether they are required for clinical management, these guidelines assign weighted utility to biopsies [1]. Although the ASCO guidelines serve as an excellent model for researchers and clinicians alike, how they will be implemented in practice remains uncertain. It is thus critical to understand the guidelines, as well as to identify barriers to their use, especially as research biopsies become an increasingly common component of clinical trials. In this issue of The Oncologist, Olympios et al. examine requests and consent for research biopsies in a series of clinical trials designed prior to the publication of the ASCO Ethical Framework [2]. Notably, only 39% of clinical trials requiring mandatory biopsies would have been compliant with the subsequently published framework. The authors assessed several study attributes to determine compliance with the ASCO framework, including the potential utility of the biopsy, the risk for patients, and the mandatory or optional request for biopsy. Informed consent forms were analyzed for thoroughness regarding biopsy risk and explanation of the scientific rationale. Multiple studies requested biopsy for exploratory objectives. Other reasons for lack of compliance included inadequate statistical analyses or disproportionate risk. Olympios et al. also report that the amount of risk of research biopsies was often inadequately described in informed consent documents. This study highlights the need for critical reappraisal of current practices and how we can best respect and serve our existing patients while advancing the science necessary to improve the care of future patients like them. With the growing impetus to identify predictive biomarkers in the era of precision medicine, it is essential to critically assess the implications of research biopsies in clinical trials. We offer a discussion on the risk-benefit analysis of inclusion of research biopsies in clinical trials, the inherent tensions for dual clinician researchers, and questions for an age of increasing commercialization of patient information.