Determining Sample Size of Pilot Trials in Traditional Chinese Medicine

ZHANG Ying; WANG Junhui; HU Yeyin; SHAO Baoyi; FU Zhanju; LIU Jianping

doi:10.13288/j.11-2166/r.2021.04.008

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Determining Sample Size of Pilot Trials in Traditional Chinese Medicine

更新时间：2021-11-10

- Determining Sample Size of Pilot Trials in Traditional Chinese Medicine
- Journal of Traditional Chinese Medicine Vol. 62, Issue 4, Pages: 307-311(2021)
- 作者机构：
  
  1. 北京中医药大学中医学院
  2. 中国中医科学院广安门医院
  3. 北京中医药大学东直门医院
  4. 香港大学李嘉诚医学院
  5. 北京交通大学经济管理学院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2021.04.008
  CLC： R28
- Published：2021
- 稿件说明：
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[1]张颖,王俊慧,胡烨胤,邵宝仪,付占局,刘建平.中医药临床研究中预试验样本量的确定[J].中医杂志,2021,62(04):307-311.

ZHANG Ying, WANG Junhui, HU Yeyin, et al. Determining Sample Size of Pilot Trials in Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2021, 62(4): 307-311.
[1]张颖,王俊慧,胡烨胤,邵宝仪,付占局,刘建平.中医药临床研究中预试验样本量的确定[J].中医杂志,2021,62(04):307-311. DOI： 10.13288/j.11-2166/r.2021.04.008.

ZHANG Ying, WANG Junhui, HU Yeyin, et al. Determining Sample Size of Pilot Trials in Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2021, 62(4): 307-311. DOI： 10.13288/j.11-2166/r.2021.04.008.

摘要

预试验是保证高质量临床研究成功开展的重要前提

同时为正式试验的样本量估算提供依据。通过阐释预试验的作用及意义

结合中医药临床研究特点

以随机对照试验为例

从可行性、精确度、试验总和、总和样本量和干预的标准效应量四个方面讨论中医药预试验样本量确定需考虑的因素

为正式试验的开展提供重要依据。

Abstract

A pilot trial is an important prerequisite to ensure the success of high-quality clinical trials

and it can also provide references for future sample size estimate of larger full-scale trilas. This study aimed to explain the purpose and significance of conducting a pilot trial in TCM. By fully considering the characteristics of TCM clinical trials

and taking randomized controlled trials（RCTs） as an example

this study discussed how to determine the sample size of pilot trials from the perspectives of feasibility

precision

minimization of total sample size and standardized effect size.

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