Comparison of Current Status of Drug Management in Clinical Trials between China and the United States
- VernacularTitle:中美药物临床试验中的药品管理现状比较
- Author:
Tong PEI
1
;
Chaoying HU
1
;
Xiao HU
1
;
Lan ZHANG
1
Author Information
1. Dept. of Pharmacy，Xuanwu Hospital of Capital Medical University，Beijing 100053，China
- Publication Type:Journal Article
- Keywords:
China;
United States;
Clinical trials drug;
Management guideline;
Management system;
Budget evaluation
- From:
China Pharmacy
2019;30(3):294-298
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To put forward the suggestions for improving drug management in clinical drug trials in China. METHODS： “Good clinical practice” “Clinical trials drug” “Drugs for clinical trials” “GCP” “Investigational drug products” as search terms， searching CNKI database， Wanfang database， PubMed database and OVID electronic journal full-text database during Jul. 2014-Jul. 2018. The differences of drug management guidelines and management systems （including management model， staffing and budget evaluation） in clinical drugs between China and the United States were summarized. The suggestions were put forward to the shortage of drugs management of clinical trials in China. RESULTS & CONCLUSIONS： A total of 154 literatures were retrieved， including 33 valid literatures. The guidelines for drug management in clinical trials in the United States were relatively perfect， such as the Guidelines for Drug Management in Clinical Trials promulgated by the American Society of Hospital Pharmacists， while China had not yet published such national guidelines. The drug management in clinical trials in the United States had two modes which is the management of part-time pharmacists in hospital pharmacy department and the management of several full-time pharmacists and pharmacy technicians. Pharmacists or pharmaceutical technicians participated in the whole process of management， and a lot of research was carried out on the budget evaluation of clinical trials drug management. Domestic clinical trials drug management included three modes which is full-time pharmacist management， full-time pharmacist and part-time nurse management， part-time pharmacist and part-time nurse management. Pharmacists and nurses jointly participated in the management， but the whole process management had not yet been achieved， and there were few studies on budget evaluation of clinical trials drug management. It is suggested that the management of clinical trials drug in China can improve the management efficiency and level of clinical trials drug by refining the management system of clinical trials drug， standardizing the management mode of clinical trials drug and carrying out management budget evaluation.
