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临床试验设计不断变化的视角。

The changing perspective of clinical trial designs.

作者信息

Ajmera Yamini, Singhal Sunny, Dwivedi S N, Dey A B

机构信息

Department of Geriatric Medicine, AIIMS, New Delhi, India.

Department of Biostatistics, AIIMS, New Delhi, India.

出版信息

Perspect Clin Res. 2021 Apr-Jun;12(2):66-71. doi: 10.4103/picr.PICR_138_20. Epub 2021 Jan 8.

DOI:10.4103/picr.PICR_138_20
PMID:34012901
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8112330/
Abstract

Maintaining health and well-being of the population is a universal priority. Governments around the globe are therefore seeking greater efficiency and better outcomes from researches being held. Although large randomized trials or systematic review of several large trials provides the highest level of evidence, the intricate cost, time, and difficulties of conventional trials have led to questions about their sustainability commanding search for alternative approaches. Demands for improved competences in medical research have led to mounting interest in newer clinical trial designs. This article provides an insight into newer clinical trial designs, including cluster trials, adaptive designs, the master protocols along with their strengths, weaknesses, and which trials design should be opted for in different clinical scenarios.

摘要

维护民众的健康和福祉是一项全球普遍的优先事项。因此,世界各国政府都在寻求提高正在进行的研究的效率并取得更好的成果。尽管大型随机试验或对多个大型试验的系统评价提供了最高级别的证据,但传统试验复杂的成本、时间和困难引发了对其可持续性的质疑,促使人们寻找替代方法。对提高医学研究能力的需求导致对更新的临床试验设计的兴趣日益浓厚。本文深入探讨了更新的临床试验设计,包括整群试验、适应性设计、主方案,以及它们的优点、缺点,以及在不同临床场景中应选择哪种试验设计。

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本文引用的文献

1
Novel Clinical Trial Designs to Improve the Efficiency of Research.新型临床试验设计以提高研究效率。
Anesthesiology. 2020 Jan;132(1):69-81. doi: 10.1097/ALN.0000000000002989.
2
Challenges with Novel Clinical Trial Designs: Master Protocols.新型临床试验设计面临的挑战:主方案。
Clin Cancer Res. 2019 Apr 1;25(7):2049-2057. doi: 10.1158/1078-0432.CCR-18-3544. Epub 2019 Jan 29.
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New clinical trial designs in the era of precision medicine: An overview of definitions, strengths, weaknesses, and current use in oncology.
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The Contribution of Artificial Intelligence in Achieving the Sustainable Development Goals (SDGs): What Can Eye Health Can Learn From Commercial Industry and Early Lessons From the Application of Machine Learning in Eye Health Programmes.人工智能在实现可持续发展目标方面的贡献:从商业行业和机器学习在眼健康计划中的应用早期经验中学到什么。
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Maximising Opportunities Post Coronavirus Disease 2019: Time to Embrace a New Era of Atrial Fibrillation Research.最大化2019冠状病毒病后的机遇:拥抱心房颤动研究新时代的时候到了。
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Cancer Treat Rev. 2019 Feb;73:20-30. doi: 10.1016/j.ctrv.2018.12.003. Epub 2018 Dec 11.
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Trials. 2018 Oct 26;19(1):586. doi: 10.1186/s13063-018-2952-5.
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Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both.用于研究多种疗法、多种疾病或两者兼有的主方案。
N Engl J Med. 2017 Jul 6;377(1):62-70. doi: 10.1056/NEJMra1510062.
6
Comparison of multi-arm multi-stage design and adaptive randomization in platform clinical trials.平台临床试验中多臂多阶段设计与适应性随机化的比较。
Contemp Clin Trials. 2017 Mar;54:48-59. doi: 10.1016/j.cct.2017.01.003. Epub 2017 Jan 13.
7
New Methods and Designs of Clinical Trials.临床试验的新方法与设计
Clin Ther. 2016 Oct 6;38(10S):e2-e3. doi: 10.1016/j.clinthera.2016.07.018.
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Adaptive Designs for Clinical Trials.临床试验的适应性设计
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