临床研究现场管理组织综合评价体系的构建研究  

A study on the construction of a comprehensive evaluation system for the site management organization of clinical trials

作　　者：黄珺[1] 袁延楠[1] 沈婉丽 刘晓红[1] 赵淑华[1] 傅志英 江旻[1] HUANG Jun;YUAN Yannan;SHEN Wanli;LIU Xiaohong;ZHAO Shuhua;FU Zhiying;JIANG Min(National Drug Clinical Trial Center,Peking University Cancer Hospital&Institute,Key laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing),Beijing 100142,China)

机构地区：[1]北京大学肿瘤医院暨北京市肿瘤防治研究所国家药物临床试验机构,恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142

出　　处：《中国研究型医院》2023年第3期5-9,共5页Chinese Research Hospitals

基　　金：首都卫生发展科研专项(2022-2Z-2153);北京市科学技术委员会资助(Z211100003521008)。

摘　　要：目的构建符合临床研究实际情况的现场管理组织(SMO)考核指标体系。方法根据11家SMO公司工作情况相关指标进行归纳并建立评价体系,采用层次分析法确定各指标权重,利用理想解排序法(TOPSIS)法计算综合评价得分,并根据得分确定各SMO公司的排名。结果构建了涵盖目标层、决策层(承接项目、整体团队、项目完成情况、人员基础、人员更换、突出贡献及重大问题共7个一级指标)、指标层(12个二级指标)的综合评价指标体系。评价结果中SMO公司A最优,公司K最劣,与工作经验判断较为一致。结论本研究建立了较为全面的评价体系,指标权重合理,可以作为SMO公司优选评价的参考依据。Objective To establish an assessment indicator system for site management organization(SMO)that aligns with the actual situation of clinical research.Methods Relevant indicators of the working conditions of 11 SMO companies were summarized,and an assessment system was established.The weight of each indicator was determined using the Analytic Hierarchy Process.The Technique for Order of Preference by Similarity to Ideal Solution(TOPSIS)method was used to calculate the comprehensive evaluation scores.The ranking of each SMO company was determined based on the scores.Results A comprehensive evaluation index system was established,which includes the goal layer,decision-making layer(acceptance of projects,overall team,project completion,personnel foundation,personnel replacement,outstanding contributions,and major issues,a total of 7 primary indicators),and an indicator layer(12 secondary indicators).According to the evaluation results,SMO company A achieved the highest score,while company K performed the worst.This result is consistent with the judgment based on work experience.Conclusion This study established a comprehensive evaluation system with reasonable indicator weights,which can serve as a reference for the optimal evaluation of SMO companies.

关 键 词：医院 临床试验 评价研究 现场管理组织 

分 类 号：R-3[医药卫生]