Design of the key links and implementation path of management in the clinical comprehensive evaluation of drug
- VernacularTitle:药品临床综合评价管理工作的核心环节及实现路径设计
- Author:
Wenwen DU
1
;
Wei XU
1
;
Xiangjun ZHU
2
Author Information
1. School of International Pharmaceutical Business，China Pharmaceutical University，Nanjing 211198，China
2. Jiangsu Provincial Health Development Research Center/Key Laboratory of Contraceptive Warning and Fertility Monitoring of the National Health Commission/Key Laboratory of Fertility Protection and Health Technology Assessment in Jiangsu Province，Nanjing 210036，China
- Publication Type:Journal Article
- Keywords:
clinical comprehensive evaluation of drug;
management mechanism;
procedure;
key links
- From:
China Pharmacy
2024;35(12):1413-1418
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To design the implementation path around the key links of the management in the clinical comprehensive evaluation of drug in China， and to provide suggestions for optimizing and perfecting the management in the clinical comprehensive evaluation of drug. METHODS Based on the relevant experience of drug evaluation management in typical countries regions at home and abroad， the discussion was performed and the management mechanism was designed from seven aspects， such as funding source， selection of topics， staff management， information management， data management， evaluation process and quality assessment. RESULTS & CONCLUSIONS In terms of funding sources， the financial department can provide funding guarantees or other alternative forms such as performance evaluations to encourage all parties to undertake the clinical comprehensive evaluation of drug projects. In terms of the selection of topics， a “top-down” or “bottom-up” selection mode can be determined according to the project’s nature and actual situation， and a selection process of “forming alternatives-setting up theme selection list-demonstrating and publishing theme selection list” can be formed. In terms of staff management， the specialty of team members should be specified， and the expert team should be established to provide clinical comprehensive evaluation of drug. In terms of information management， the national/provincial basic informational platform should be established， and the registration system should be established. In terms of data management， a regional health data-sharing platform should be formed and the “application-checking-utilization” mechanism should be conducted. In terms of the evaluation process， the evaluation procedures that concern on project implementation plan demonstration system and project closing review system should be constructed. In terms of quality assessment， quality assessment and reward and punishment mechanism for project completion，that consider the quality of management first while focusing on the technical quality， can be established. The management mechanism based on the standardized implementation of the seven key links will standardize the development of clinical comprehensive evaluation of drugs in China to some extent， and help improve the quality of clinical comprehensive evaluation projects for drugs.
