Avoiding Delays in Reporting Time-to-Event Randomized Trials: Calendar Backstops and Other Approaches.

IF 42.1 1区 医学 Q1 ONCOLOGY Journal of Clinical Oncology Pub Date : 2024-11-01 Epub Date: 2024-05-17 DOI:10.1200/JCO.24.00025
Megan Othus, Boris Freidlin, Edward L Korn
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Abstract

New oncology therapies that extend patients' lives beyond initial expectations and improving later-line treatments can lead to complications in clinical trial design and conduct. In particular, for trials with event-based analyses, the time to observe all the protocol-specified events can exceed the finite follow-up of a clinical trial or can lead to much delayed release of outcome data. With the advent of multiple classes of oncology therapies leading to much longer survival than in the past, this issue in clinical trial design and conduct has become increasingly important in recent years. We propose a straightforward prespecified backstop rule for trials with a time-to-event analysis and evaluate the impact of the rule with both simulated and real-world trial data. We then provide recommendations for implementing the rule across a range of oncology clinical trial settings.

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避免事件时间随机试验报告的延迟:日历逆止器及其他方法。
新的肿瘤疗法能延长患者的生命,超出最初的预期,并能改善后期治疗,这可能会导致临床试验的设计和实施复杂化。特别是对于基于事件分析的试验,观察所有方案指定事件的时间可能会超过临床试验的有限随访时间,或导致结果数据的发布大大延迟。随着多类肿瘤疗法的出现,患者的生存期比过去大大延长,近年来临床试验设计和实施中的这一问题变得越来越重要。我们为采用时间到事件分析的试验提出了一个简单明了的预设后备规则,并通过模拟和实际试验数据评估了该规则的影响。然后,我们提出了在一系列肿瘤临床试验中实施该规则的建议。
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来源期刊
Journal of Clinical Oncology
Journal of Clinical Oncology 医学-肿瘤学
CiteScore
41.20
自引率
2.20%
发文量
8215
审稿时长
2 months
期刊介绍: The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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