Principles of Good Clinical Trial Design

被引：12

作者：

An, Ming-Wen ^{[1
]}

Quyen Duong ^{[2
]}

Le-Rademacher, Jennifer ^{[2
]}

Mandrekar, Sumithra J. ^{[2
]}

机构：

[1] Vassar Coll, Dept Math & Stat, 124 Raymond Ave, Poughkeepsie, NY 12604 USA

[2] Mayo Clin, Dept Hlth Sci Res, Rochester, MN USA

来源：

JOURNAL OF THORACIC ONCOLOGY | 2020年 / 15卷 / 08期

关键词：

Principles; Clinical trial; Design; Collaboration; GUIDELINES;

D O I：

10.1016/j.jtho.2020.05.005

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Clinical trials are a fundamental component of medical research and serve as the main route to obtain evidence of the safety and efficacy of treatment before its approval. A trial's ability to provide the intended evidence hinges on appropriate design, background knowledge, trial rationale to sample size, and interim monitoring rules. In this article, we present some general design principles for investigators and their research teams to consider when planning to conduct a trial. (C) 2020 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

引用

页码：1277 / 1280

页数：4

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