A Cross‐Sectional Survey on the Current Status and Influencing Factors of Clinical Investigators’ Competencies in Beijing, China

Objective Clinical investigators are essential for assessing the clinical value, safety, and efficacy of innovative drugs. However, comprehensive data on their competency levels are limited in China. This study aimed to evaluate the current status and key determinants of clinical investigators’ competencies. Methods We conducted a multicenter, cross‐sectional study in 40 tertiary hospitals in Beijing in August 2023, enrolling 1397 clinical investigators. Competency was assessed via a self‐administered questionnaire, and influencing factors were identified using multivariate logistic regression. Results The median overall competency score was 103 (range: 32–160). Among 194 principal investigators (PIs), prominent competency scores ranged from 25 to 120, with a median of 93. Several factors were significantly associated with higher competency, including advanced education (doctoral degree: aOR = 1.75, 95% CI: 1.21–2.55), professional title (midlevel title: aOR = 1.77, 95% CI: 1.20–2.59; senior‐level title: aOR = 2.91, 95% CI: 1.78–4.75), experience leading clinical trials (≥ 1 trial as PI: aOR = 2.38, 95% CI: 1.69–3.36), and GCP training frequency (at least semiannually: aOR = 1.39, 95% CI: 1.07–1.81). Conclusions Efforts should target areas of underperformance, particularly by encouraging the pursuit of advanced degrees, senior professional accreditation, PI experience, and regular GCP training. Competency development requires systematic training rather than mere seniority. Consistent GCP training and adherence to international competency standards are crucial for elevating trial quality and facilitating China’s integration into global drug development.