A survey on the operational management issues of drug clinical trials in the yangtze river delta region
10.12206/j.issn.2097-2024.202311002
- VernacularTitle:长三角区域药物临床试验运行管理问题的调查研究
- Author:
Yougen WU
1
;
Yuting GU
1
;
Ju XIA
1
;
Qingqing QIAN
2
Author Information
1. The Fifth People’s Hospital of Shanghai, Fudan University:.
2. The Fifth People’s Hospital of Shanghai, Fudan University:;Drug Clinical Trials Institution, b. Dean’s Office, c. Department of Pharmacy, Shanghai, 200240 China;Department of Pharmacy,The Fifth People’s Hospital of Shanghai, Fudan University: Shanghai 200240, China.
- Publication Type:Pharmacyadministration
- Keywords:
medical institutions;
drug clinical trials;
operation management;
medical staff
- From:
Journal of Pharmaceutical Practice and Service
2026;44(2):103-107
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the problems in the operation and management of drug clinical trials and put forward targeted suggestion. Methods An electronic questionnaire survey was conducted among medical staff in about 80 hospitals in the yangtze river delta region. Results 606 valid questionnaires were received. 71% of the respondents expressed their willingness to study and participate in drug clinical trials. There were significant differences in the cognitive demands, willingness and motivation of the respondents with different occupations and educational backgrounds about the drug clinical trial work （P<0.05）. During the operation of drug clinical trials, respondents reported the main factors affecting the quality of clinical trials which including good clinical practice (GCP) awareness and subjective enthusiasm of investigators （response rate 27%）, job stability of supervisors and research coordinators （27%）, compliance of subjects （45%）, quality control of the whole process of the circulation of test drugs, medical devices and biological samples （52%）, and the informatization level of clinical trial institutions （30%）. Conclusion Hospitals, institutions and project teams could take measures to cultivate and stabilize the drug clinical trial talent team, improve the quality management system of drug clinical trials, improve work efficiency, and promote the high-quality development of drug clinical trials in medical institutions.
