Analysis of the Research Status of Registry-based Randomized Controlled Trials

ZHENG Chensi; LIU Baoyan; FANG Yigong

doi:10.13288/j.11-2166/r.2020.12.009

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Analysis of the Research Status of Registry-based Randomized Controlled Trials

更新时间：2021-11-10

- Analysis of the Research Status of Registry-based Randomized Controlled Trials
- Journal of Traditional Chinese Medicine Vol. 61, Issue 12, Pages: 1054-1058(2020)
- 作者机构：
  
  1. 中国中医科学院针灸研究所
  2. 中国中医科学院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2020.12.009
  CLC： R24
- Published：2020
- 稿件说明：
移动端阅览
[1]郑晨思,刘保延,房繄恭.基于注册登记研究的随机对照试验研究现状分析[J].中医杂志,2020,61(12):1054-1058.

ZHENG Chensi, LIU Baoyan, FANG Yigong. Analysis of the Research Status of Registry-based Randomized Controlled Trials[J]. Journal of Traditional Chinese Medicine2020, 61(12): 1054-1058.
[1]郑晨思,刘保延,房繄恭.基于注册登记研究的随机对照试验研究现状分析[J].中医杂志,2020,61(12):1054-1058. DOI： 10.13288/j.11-2166/r.2020.12.009.

ZHENG Chensi, LIU Baoyan, FANG Yigong. Analysis of the Research Status of Registry-based Randomized Controlled Trials[J]. Journal of Traditional Chinese Medicine2020, 61(12): 1054-1058. DOI： 10.13288/j.11-2166/r.2020.12.009.

摘要

注册登记研究作为真实世界研究的一种形式目前应用越来越广泛

但存在将注册登记研究等同于没有人为干预的观察性研究的误区。事实上

注册登记研究既包括观察性研究

也包括随机对照试验。提出基于注册登记研究的随机对照试验的概念并整理国内外该类型试验

详细阐述了其节约成本、结果具有外推性以及能获得更完整随访数据的特征

并从数据质量、方法学、伦理角度分析其面临的挑战

为根据中医临床特点寻找合适的疗效评价方法提供思路。

Abstract

As a form of real world study（RWS）

registry study has been applied more and more widely. But people mistakenly equate registry study with no-intervention observational study. In fact

registry study include both observational study and randomized controlled trials. In this paper

the concept of registry-based randomized controlled trials（rRCT） was discussed

and trials of this type worldwide were collected. The paper elaborated on its characteristics of cost-saving

extrapolated results and more complete follow-up data

and analyzed its challenges from the perspective of data quality

methodology

and ethics

in order to provide a evaluation method suitable for curative effects of traditional Chinese medicine.

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