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
;
Aijuan SHENG
;
Nan BAI
;
Yanfen CHEN
;
Zhongguang YU
Author Information
1. 北京协和医院临床药理研究中心,北京 100005
- Keywords:
clinical research benefits;
risk-benefit;
medical ethics;
ethical review
- From:
Chinese Medical Ethics
2024;37(4):448-452
- CountryChina
- Language:Chinese
-
Abstract:
Objective:The 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.Methods:The 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.Results:Twenty-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.Conclusion:The 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.
