Platform trials-an emerging methodology for perioperative medicine: a narrative review.

IF 2 3区 医学 Q2 ANESTHESIOLOGY
Tom E F Abbott, Sarah-Louise Watson, Salma Begum, Priyanthi Dias, Joanne S Haviland, James Glasbey, Lawani Ismail, Sharon Love, Rupert M Pearse
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Abstract

The traditional model for testing new treatments, before widespread usage in clinical practice, is the parallel group randomised trial. However, these are often inefficient, time-consuming and expensive, which can be barriers to the timely improvement of clinical care. This is a particular issue for anaesthesia and perioperative medicine where funding for large clinical trials is often scarce. Platform trials are an emerging methodology for testing new interventions, which offer benefits over the traditional parallel group paradigm. Platform trials have the ability to test multiple interventions at the same time, and to add or remove interventions during the course of the programme without undermining the validity or integrity of the trial findings. They are most often structured around a master protocol, which describes the core methods and research governance processes, with each intervention described in either a sub-section or appendix to the master protocol. The principal benefit to researchers and to research funders is that, unlike the sequential parallel group trial model, platform trials can use the same research infrastructure (e.g. database, standard operating procedures etc.) to answer multiple research questions, which is much more time and cost effective. The benefits of platform trials can be further enhanced with the use of adaptive designs or by sharing control patients, for example, by using a multi-arm multi-stage design. Perioperative medicine, anaesthesia and surgery are ideally placed to benefit from platform trials.

平台试验——围手术期医学的一种新兴方法:叙述性回顾。
在广泛应用于临床实践之前,测试新疗法的传统模式是平行组随机试验。然而,这些方法往往效率低下,耗时且昂贵,这可能成为及时改善临床护理的障碍。这对于麻醉和围手术期医学来说是一个特别的问题,因为大型临床试验的资金往往是稀缺的。平台试验是一种用于测试新干预措施的新兴方法,它比传统的平行群体范式更具优势。平台试验有能力同时测试多种干预措施,并在不破坏试验结果的有效性或完整性的情况下,在项目过程中增加或删除干预措施。它们通常是围绕主协议构建的,主协议描述了核心方法和研究治理过程,每个干预都在主协议的子部分或附录中描述。研究人员和研究资助者的主要好处是,与顺序平行组试验模型不同,平台试验可以使用相同的研究基础设施(例如数据库,标准操作程序等)来回答多个研究问题,这更节省时间和成本效益。平台试验的益处可以通过使用自适应设计或通过共享对照患者(例如,通过使用多臂多阶段设计)进一步增强。围手术期用药、麻醉和手术是平台试验的理想选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
自引率
3.80%
发文量
55
审稿时长
10 weeks
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