Design of the key links and implementation path of management in the clinical comprehensive evaluation of drug

DU Wenwen; XU Wei; ZHU Xiangjun

doi:10.6039/j.issn.1001-0408.2024.12.01

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Design of the key links and implementation path of management in the clinical comprehensive evaluation of drug

更新时间：2025-09-26

- Design of the key links and implementation path of management in the clinical comprehensive evaluation of drug
- ZHONGGUO YAOFANG Vol. 35, Issue 12, Pages: 1413-1418(2024)
- 作者机构：
  
  1.中国药科大学国际医药商学院，南京　211198
  2.江苏省卫生健康发展研究中心/国家卫生健康委避孕药具警戒与生育力监测重点实验室/江苏省生育力保护与卫生技术评估重点实验室，南京　210036
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.12.01
  CLC： R95
- Received：23 November 2023，
  
  Revised：2024-05-15，
  
  Accepted：29 May 2024，
  
  Published：30 June 2024
- 稿件说明：
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杜雯雯,徐伟,朱向珺.药品临床综合评价管理工作的核心环节及实现路径设计[J].中国药房,2024,35(12):1413-1418.

DU Wenwen,XU Wei,ZHU Xiangjun.Design of the key links and implementation path of management in the clinical comprehensive evaluation of drug[J].ZHONGGUO YAOFANG,2024,35(12):1413-1418.
杜雯雯,徐伟,朱向珺.药品临床综合评价管理工作的核心环节及实现路径设计[J].中国药房,2024,35(12):1413-1418. DOI： 10.6039/j.issn.1001-0408.2024.12.01.

DU Wenwen,XU Wei,ZHU Xiangjun.Design of the key links and implementation path of management in the clinical comprehensive evaluation of drug[J].ZHONGGUO YAOFANG,2024,35(12):1413-1418. DOI： 10.6039/j.issn.1001-0408.2024.12.01.

摘要

目的

围绕我国药品临床综合评价管理工作中的核心环节设计其实现路径，为进一步优化和完善我国药品临床综合评价管理工作提供建议。

方法

在借鉴国内外典型国家/地区药品评价管理工作相关经验的基础上，围绕资金来源、主题遴选、人员管理、信息化管理、数据管理、评价流程、完成质量考核七大核心环节展开探讨，并设计我国药品临床综合评价管理机制。结果与

结论

资金来源方面，可由财政部门给予经费保障或以绩效考核等其他可替代形式鼓励各方开展药品临床综合评价工作；主题遴选方面，可根据项目性质及实际情况确定“自上而下”或“自下而上”的遴选模式，同时形成“建立主题备选库-形成主题遴选清单-论证并发布主题清单”的遴选流程；人员管理方面，应精确匹配项目组成员的专业方向，并组建专家团队服务药品临床综合评价工作；信息化管理方面，可建立国家/省级药品临床综合评价基础信息平台，形成项目立项登记制度；数据管理方面，可组建区域性的健康数据共享平台，实行数据“申请-审核-使用”制度；评价流程方面，可实施以项目实施方案论证制度和项目结题评审制度为核心的评价流程；完成质量考核方面，则可建立“管理质量考核为先，技术质量考核为主”的项目完成质量考核及奖惩机制。基于七大核心环节规范实施的管理机制，将能在一定程度上规范我国药品临床综合评价工作的开展，有助于提高药品临床综合评价项目的质量。

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 experie

nce 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.

关键词

Keywords

references

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