浏览全部资源
扫码关注微信
- Journal Information
- Archive
- Submission
- For Reviewers
- Statement and Policies
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： R95Published：30 June 2024，
Received：23 November 2023，
Revised：15 May 2024，
扫 描 看 全 文
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 Δ[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 Δ[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
2
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
2
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
2
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
2
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
2
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
2
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
药品临床综合评价管理机制流程核心环节
Keywords
management mechanismprocedurekey links
references
赵锐，石秀园，胡若飞，等. 省域药品临床综合评价工作的关键环节探讨[J]. 卫生经济研究，2022，39（5）：17-20.
ZHAO R，SHI X Y，HU R F，et al. Discussion on the key links of comprehensive clinical evaluation of drugs in provinces[J]. Health Econ Res，2022，39（5）：17-20.
赵锐，胡若飞，石秀园，等. 我国药品临床综合评价全面质量管理体系的构建[J]. 中国药房，2022，33（12）：1409-1414，1429.
ZHAO R，HU R F，SHI X Y，et al. Construction of total quality management system of clinical comprehensive evaluation of drugs in China[J]. China Pharm，2022，33（12）：1409-1414，1429.
王舒，董名扬，陈朋军，等. 药品临床综合评价技术方法的质量控制[J]. 中国药房，2023，34（3）：275-279.
WANG S，DONG M Y，CHEN P J，et al. Quality control of the technology method of clinical comprehensive drug evaluation[J]. China Pharm，2023，34（3）：275-279.
PBAC. Procedure guidance for listing medicines on the pharmaceutical benefits scheme[EB/OL].（2022-12-21）[2023-11-18]. https：//www.pbs.gov.au/industry/listing/procedure-guidance/files/Procedure-guidance-for-listingme-dicines-on-the-Pharmaceutical-Benefits-Scheme-v2.5.pdfhttps://www.pbs.gov.au/industry/listing/procedure-guidance/files/Procedure-guidance-for-listingme-dicines-on-the-Pharmaceutical-Benefits-Scheme-v2.5.pdf.
PBAC. Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee（PBAC）[EB/OL].（2016-09-01）[2023-11-18]. https：//pbac.pbs.gov.au/https://pbac.pbs.gov.au/.
赵琨，肖月，池延花，等. 英国NICE技术评估和临床指南的实施对我们的启示[J]. 中国卫生资源，2011，14（3）：193-195.
ZHAO K，XIAO Y，CHI Y H，et al. Implementation of UK NICE’s technology evaluation and clinical guidelines and its implication[J]. Chin Health Resour，2011，14（3）：193-195.
NICE. Guide to the processes of technology appraisal[EB/OL].（2018-05-30）[2023-11-18]. https：//www.nice.org.uk/process/pmg19https://www.nice.org.uk/process/pmg19.
NICE. NICE health technology evaluation topic selection：the manual[EB/OL].（2018-05-30）[2022-01-31]. https：//www.nice.org.uk/process/pmg37/chapter/summary-of-the-topic-selection-processhttps://www.nice.org.uk/process/pmg37/chapter/summary-of-the-topic-selection-process.
CADTH. Procedures for CADTH reimbursement reviews[EB/OL].（2023-09-01）[2023-11-18]. https：//www.cadth.ca/sites/default/files/Drug_Review_Process/CADTH%20-Drug%20Reimbursement%20Review%20Procedures.pdfhttps://www.cadth.ca/sites/default/files/Drug_Review_Process/CADTH%20-Drug%20Reimbursement%20Review%20Procedures.pdf.
邱英鹏，赵琨，王晓玲，等. 儿童药品临床综合评价主题的遴选方法初探[J]. 中国药物评价，2021，38（3）：177-182.
QIU Y P，ZHAO K，WANG X L，et al. Exploration on topic selection method for evaluation of pediatric medicine in China[J]. Chin J Drug Eval，2021，38（3）：177-182.
江苏：药品临床综合评价路径需标准化[J]. 中国卫生，2021（6）：83.
Jiangsu：the path of comprehensive clinical evaluation of drugs needs to be standardized[J]. China Health，2021（6）：83.
《中国医疗机构药品临床综合评价质量控制体系共识》专家组. 中国医疗机构药品临床综合评价质量控制体系共识[J]. 中国药业，2022，31（15）：1-9.
Expert Group of Consensus on Quality Control System for Comprehensive Clinical Evaluation on Medicine in Chinese Healthcare Institutions. Consensus on quality control system for comprehensive clinical evaluation on medicine in Chinese healthcare institutions[J]. China Pharm，2022，31（15）：1-9.
0
Views
1
下载量
0
CSCD
- L-PDFDownload
- WORDDownload
- Meta-XMLDownload
- BibTeXDownload
- EndnoteDownload
- RefMan Download
- NoteExpressDownload
- NoteFirstDownload
Publicity Resources
Related Articles
Related Author
Related Institution
- Address：8th Floor, Sihuan Building, No. 129 Daping Main Street, Yuzhong District, Chongqing, China Postal code：400042
- Technical support is provided by Beijing Founder Electronics co., LTD 渝ICP备15012710号
公网安备50010302001817 - It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
- Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.