Wang Xin, Zhao Shuang, Yang Han, Miao Miao, An Siwei, Yao Wenbing
School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, 210009, China.
Clinical Trial Research Center, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, 100730, China.
Ther Innov Regul Sci. 2025 Jan;59(1):45-53. doi: 10.1007/s43441-024-00688-5. Epub 2024 Nov 29.
To construct a competency model for clinical investigators involved in the process of new drug development, providing a reference for the training, selection and assessment of clinical investigators.
The Behavioral Event Interview (BEI) method was used to interview 12 excellent clinical investigators and 8 clinical investigators of average performance. Each competency characteristic was extracted from the interview text by semantic coding. Total frequency, total score, average score and highest score were calculated for each competency element. Category agreement coefficient, coefficient of reliability and Spearman correlation coefficient were used to assess the consistency of two coders for coding and classification. Independent-samples Mann-Whitney U test was applied to compare the differences in competency elements between the group of excellent clinical investigators and the group of average investigators.
The average coefficient of category agreement was 0.671, and the average coefficient of reliability was 0.803. No significant differences were observed between the two groups in the aspect of interview time (P = 0.190) and the interview words (P = 0.184), indicating comparability between the two groups. However, there was a clear performance difference between the excellent and average groups. In addition, we found that the competency model for clinical investigators contained 24 prominent competence elements and 8 benchmark competency elements.
Clinical investigator is a medical professional who is involved in a highly research-intensive and practical job, where prominent competency element largely reflects clinical practice skills, innovation and awareness of Good Clinic Practice (GCP). Our results provide a reference for assessing clinical investigators' competencies, encouraging and guiding them to modify their behaviors according to the competency model, and also cultivating clinical investigators so as to improve the competence level of clinical investigators.
构建参与新药研发过程的临床研究者胜任力模型，为临床研究者的培训、选拔及考核提供参考。
采用行为事件访谈法对12名优秀临床研究者和8名表现一般的临床研究者进行访谈。通过语义编码从访谈文本中提取各胜任特征。计算各胜任要素的总频次、总分、平均分及最高分。采用类别一致性系数、信度系数和Spearman相关系数评估两名编码员编码及分类的一致性。应用独立样本Mann-Whitney U检验比较优秀临床研究者组和一般研究者组在胜任要素上的差异。
类别一致性系数平均为0.671，信度系数平均为0.803。两组在访谈时间（P = 0.190）和访谈字数（P = 0.184）方面差异无统计学意义，表明两组具有可比性。然而，优秀组和一般组之间存在明显的表现差异。此外，我们发现临床研究者胜任力模型包含24个突出胜任要素和8个基准胜任要素。
临床研究者是从事高度研究密集型和实践性工作的医学专业人员，突出胜任要素很大程度上反映了临床实践技能、创新能力和药物临床试验质量管理规范（GCP）意识。我们的研究结果为评估临床研究者的胜任力、鼓励和引导他们根据胜任力模型调整行为以及培养临床研究者以提高临床研究者的胜任水平提供了参考。
