在主要会议上为随机癌症试验讨论者提供指导。

IF 7.6 1区 医学 Q1 ONCOLOGY
Elizabeth A. Eisenhauer , Omar Abdihamid , Christopher M. Booth , Nathan Cherny , Antonio T. Fojo , Bishal Gyawali , Bernard L. Marini , Ghulam Rehman Mohyuddin , Madeline Pe , Gregory R. Pond , Enrique Soto-Perez-de-Celis , Ian F. Tannock , Dario Trapani , Michelle Tregear , Winette T.A. van der Graaf , Brooke E. Wilson
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引用次数: 0

摘要

背景:在重要的癌症会议上,可能改变实践的随机临床试验(rct)的讨论者有重要的责任,将新的研究置于当前癌症护理的背景下,评估数据的普遍性,评估结果是否对患者有意义,并有效和客观地向不同的受众传达这些信息。如果没有一个标准的方法来批评临床试验设计或结果,讨论者可能会忽视他们评论中的关键弱点。常识肿瘤学(cso): cso计划于2023年启动,目前由> 1000名临床医生、学者、政策制定者和患者组成。它的主要愿景是,无论患者居住在哪里,都应该有机会获得能够显著改善预后的癌症治疗。要做到这一点,一个重点是努力改进证据的产生和报告。为讨论者提供指导:作为这项工作的一部分,公民社会组织随机对照试验工作组确定了用于讨论者演讲的关键要素,以促进对随机对照试验进行平衡的高质量审查。评估要素包括:a)研究设计:研究问题的评估,人群和对照组的选择,盲法的使用,主要和次要终点的选择;b)研究结果:治疗交付、交叉试验的使用、审查的影响、计划外分析、患者报告的结果、不良反应;c)结论:评估试验结果的价值和普遍性,当声称有积极结果时,评估它们在对患者重要的结局方面是否比目前的护理标准提供了有意义的益处。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Guidance for discussants of randomized cancer trials at major meetings

Background

Discussants of potentially practice-changing randomized clinical trials (RCTs) at major cancer meetings have an important responsibility to place new research in the context of current cancer care, to assess the generalizability of the data, to evaluate whether the outcomes are meaningful to patients, and to convey this information effectively and objectively to a diverse audience. Without a standard approach to critiquing clinical trial design or results discussants may overlook key weaknesses in their commentary.

Common Sense Oncology (CSO)

The CSO initiative was launched in 2023 and is now comprised of an international collective of > 1000 clinicians, academics, policymakers, and patients. Its primary vision is that patients should have access to cancer treatments that provide meaningful improvements in outcomes, irrespective of where they live. To do this, one focus is to try to improve evidence generation and reporting.

Guidance for discussants

As part of this work, the CSO RCT Working Group has identified key elements for use in the development of discussant presentations to facilitate a balanced high-quality examination of RCTs. Elements include assessment of: a) Study design: evaluation of the study question, selection of population and control arm, use of blinding, choice of primary and secondary endpoints; b) Study results: treatment delivery, use of crossover, impact of censoring, unplanned analyses, patient reported outcomes, adverse effects; and c) Conclusions: Appraise the value and generalizability of trial results and, when positive results are claimed, assess if they offer meaningful benefits over current standard(s) of care in outcomes of importance to patients.
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来源期刊
European Journal of Cancer
European Journal of Cancer 医学-肿瘤学
CiteScore
11.50
自引率
4.80%
发文量
953
审稿时长
23 days
期刊介绍: The European Journal of Cancer (EJC) serves as a comprehensive platform integrating preclinical, digital, translational, and clinical research across the spectrum of cancer. From epidemiology, carcinogenesis, and biology to groundbreaking innovations in cancer treatment and patient care, the journal covers a wide array of topics. We publish original research, reviews, previews, editorial comments, and correspondence, fostering dialogue and advancement in the fight against cancer. Join us in our mission to drive progress and improve outcomes in cancer research and patient care.
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