Exploration and construction of an evaluation indicator framework for clinical research benefits in China
10.12026/j.issn.1001-8565.2024.04.11
- VernacularTitle:我国临床研究受益评估指标框架的探讨与构建
- Author:
Aiyi ZHANG
1
;
Hu CHEN
2
;
Aijuan SHENG
3
;
Nan BAI
4
;
Yanfen CHEN
5
;
Zhongguang YU
6
Author Information
1. Clinical Pharmacology Research Center， Peking Union Medical College Hospital， Beijing 100005， China
2. Discipline Construction Office， Cangzhou Central Hospital， Cangzhou 061017， China
3. Ethics Office， Beijing You An Hospital， Capital Medical University， Beijing 100069， China
4. Medical Ethics Office， Chinese People’s Liberation Army General Hospital， Beijing 100039， China
5. Department of Scientific Research， China-Japan Friendship Hospital， Beijing 100029， China
6. Respiratory Center， China-Japan Friendship Hospital， Beijing 100029， China
- Publication Type:Journal Article
- Keywords:
clinical research benefits;
risk-benefit;
medical ethics;
ethical review
- From:
Chinese Medical Ethics
2024;37(4):448-452
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveThe aim is to construct an evaluation framework for clinical research benefits， and provide a reference for the formulate of evaluation standards for clinical research benefits. MethodsThe Delphi method was used to carry out expert consultation， and the mean， score of importance， coefficient of variation and coordination， etc. of evaluation indicators were summarized and calculated， to screen evaluation indicators for clinical research benefits. ResultsTwenty-three experts in this field were selected for correspondence， and their enthusiasm was 100% in both rounds， the authority coefficients were≥0.90， and Kendall’s coefficients of concordance were<0.25 （P<0.001）. By referring to the mean and coefficient of variation of the indicators， as well as combining them with expert suggestions， an evaluation framework for clinical research benefits was ultimately formed with 2 primary indicators， 5 secondary indicators， and 8 tertiary indicators. ConclusionThe evaluation framework for clinical research benefits constructed in this paper can comprehensively evaluate the research benefits， as well as provide a basis for reasonably determining the research risk-benefit ratio and developing quantitative evaluation tools for clinical research benefits.
