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药物临床试验质量管理人员核心能力评价指标体系构建及实证应用
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| 篇名： | 药物临床试验质量管理人员核心能力评价指标体系构建及实证应用 |
| TITLE： | Development and application of core competence assessment index system among drug clinical trial quality control personnel |
| 摘要： | 目的 建立适用于我国药物临床试验质量管理人员的核心能力评估指标体系，并进行实证应用。方法基于药物临床试验质量管理人员的工作范围、职责及角色定位，通过文献分析和专家咨询，初步构建核心能力评估指标体系初稿；采用德尔菲法邀请17位专家对指标体系初稿进行函询、修改，最终形成完整的评估体系。应用构建的指标体系，在2024年3－5月对38家药物临床试验机构的110位质量管理人员进行电子问卷调查，对其指标重要性评分和自我能力评分进行对比。结果两轮专家函询问卷回收率均为100%，Kendall’sW系数分别为0.256、0.277（P均小于0.001），专家权威系数为0.946。最终确定的药物临床试验质量管理人员核心能力评估体系包括个人专业能力，沟通表达能力，实施条件的检查，知情同意过程的检查，临床试验实施过程的检查，不良事件处理、报告和记录的检查，临床试验记录的检查，试验报告的审核，其他工作的检查9个一级指标以及107个二级指标。实证调查显示，110位受访者在70个指标的重要性评分与自我能力评分上存在显著性差异（P＜0.05），重要性评分与自我能力评分差值较大的指标包括很熟悉《药物临床试验质量管理规范》的内容和要求（差值0.34分）、熟悉国家和机构制定的药物临床试验核查重点（差值0.24分）等。结论构建的指标体系科学性和可靠性较好。临床试验质量管理人员在多项关键能力方面存在短板，迫切需要有针对性的培训来提升其综合素养。 |
| ABSTRACT： | OBJECTIVE To establish a core competency evaluation system for drug clinical trial quality management personnel in China and validate its application. METHODS Based on the scope of work， responsibilities， and role positioning of quality management personnel in drug clinical trials， a preliminary draft of the core competency evaluation system was constructed through literature analysis and expert consultation. The draft was refined through a Delphi method involving 17 experts who provided feedback and revisions， ultimately forming a complete evaluation system. The developed system was applied to conduct electronic surveys from March to May 2024 among 110 quality management personnel from 38 drug clinical trial institutions， comparing their scores on indicator importance and self-assessed capabilities. RESULTS The response rate of both rounds of questionnaire survey was 100%， with Kendall’s W coefficients of 0.256 and 0.277 （P＜0.001 for both）， and an expert authority coefficient of 0.946. The finalized evaluation system for core competencies of clinical trial quality management personnel comprised 9 primary indicators， covering individual professional competence， communication skills， implementation condition verification， informed consent process review， clinical trial execution monitoring， adverse event disposal， reporting and documentation， trial record examination， trial report auditing， and inspection of other tasks， and 107 secondary indicators. Empirical research revealed significant discrepancies between importance scores and self-assessed competency scores across 70 indicators among 110 respondents （P＜0.05）. Indicators with relatively notable gaps between importance scores and self-assessed competency scores included in-depth understanding of Good Clinical Practice （GCP） requirements （0.34-point gap）， familiarity with national and institutional clinical trial inspection priorities （0.24-point gap），etc. CONCLUSIONS The indicator system constructed in this study has good scientificity and reliability. Clinical trial quality management personnel demonstrate deficiencies in multiple critical competencies， highlighting the urgent need for targeted training programs to enhance their overall professional capabilities. |
| 期刊： | 2025年第36卷第24期 |
| 作者： | 陈瑜；蒋清青；叶果；毛魏然；尹园园；张孟娟；孙朴；陈霞 |
| AUTHORS： | CHEN Yu，JIANG Qingqing，YE Guo，MAO Weiran，YIN Yuanyuan，ZHANG Mengjuan，SUN Pu，CHEN Xia |
| 关键字： | 药物临床试验；质量管理人员；核心能力评估指标体系；德尔菲法；问卷调查 |
| KEYWORDS： | drug clinical trial； quality management personnel； core competency evaluation system； Delphi method； |
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