根据外部证据调整正在进行的 RAMPART 试验的设计:历时多年的试验和报告范例

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-10-18 DOI:10.1016/j.conctc.2024.101381
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引用次数: 0

摘要

确定新药在癌症辅助治疗中疗效的临床试验通常需要多年才能完成。在此期间,外部因素可能会影响招募和报告计划。本文介绍了我们如何修改 RAMPART 试验(NCT03288532)的设计,该试验旨在研究肾癌辅助治疗中的免疫检查点抑制剂疗法。该试验是在肾切除术后尚无全球公认的辅助治疗策略时启动的。随后,许多早期肾癌患者的治疗标准发生了变化,这意味着继续招募患者已不再可行。我们需要找到一种方法,既能最大限度地发挥 RAMPART 参与者对免疫检查点抑制剂疗法证据基础的贡献,又不会引入偏见或损害试验结果的完整性。我们介绍了如何在对试验中积累的数据保持盲法的同时,商定并纳入所有设计和时间安排上的变更,从而保护未来结果的可靠性。我们分享设计修改的细节是为了给其他可能有类似经历的人提供指导,尤其是当更多的药物和药物组合被开发出来并在类似的辅助环境中进行研究时。
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Adapting the design of the ongoing RAMPART trial in response to external evidence: An example for trials which take many years to run and report
Clinical trials to establish the efficacy of new agents in the adjuvant cancer setting typically take many years to complete. During that time, external factors can impact recruitment and reporting plans. An example is a new standard of care becoming available during the recruitment period.
In this paper we describe how we modified the design of the RAMPART trial (NCT03288532) which was set up to investigate immune checkpoint inhibitor therapy in the adjuvant renal cancer setting. The trial had been initiated when no globally accepted adjuvant strategy after nephrectomy existed. A subsequent change in the standard of care for many patients with early renal cancer meant it was no longer feasible to continue to recruit. We needed to find a way to maximise the contribution that RAMPART participants could make to the evidence base for immune checkpoint inhibitor therapy without introducing bias or detriment to the integrity of the trial results. We describe how we agreed and incorporated all design and timeline changes while remaining blinded to accumulating data within the trial, thus protecting the reliability of the future results. We share details of our design modifications to guide others who may have similar experiences, particularly as more agents and combinations of agents are developed and investigated in similar adjuvant settings.
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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