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利用创新的试点设计提高试验效率:试点和可行性研究开展与报告的下一阶段。

Improving the efficiency of trials using innovative pilot designs: the next phase in the conduct and reporting of pilot and feasibility studies.

作者信息

Thabane Lehana, Lancaster Gillian

机构信息

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON Canada.

Professor Gillian Lancaster, Institute of Primary Care and Health Sciences, Keele University, Keele, UK.

出版信息

Pilot Feasibility Stud. 2017 Jul 6;4:14. doi: 10.1186/s40814-017-0159-2. eCollection 2018.

Abstract

With continuously increasing costs of conducting trials, use of innovative approaches-such as pragmatic trials, registry-based randomised trials, adaptive trials, personalised medicine trials, platform trials, and basket trials-to the design and conduct of clinical trials has been advocated as one of the most promising solutions. In this editorial, we propose that the next wave of feasibility or pilot studies should focus on assessing the feasibility of trials using these designs, which we see as an imperative in order to unleash their potential to reduce trial costs and accelerate the drug development process and the search for best treatments, so that the right treatments can be delivered as soon as possible to the right patients.

摘要

随着开展试验的成本不断增加,采用创新方法(如实证性试验、基于注册登记的随机试验、适应性试验、个性化医学试验、平台试验和篮子试验)进行临床试验的设计与实施,已被视作最具前景的解决方案之一而得到倡导。在这篇社论中,我们提议下一波可行性或预试验研究应聚焦于评估采用这些设计的试验的可行性,我们认为这是释放其降低试验成本、加速药物研发进程以及寻找最佳治疗方法的潜力的必要之举,以便能尽快将正确的治疗方法提供给合适的患者。

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