江苏省药品临床综合评价项目质量控制指南

张晶晶, 李洪超, 朱建国, 李悦, 马爱霞, 缪丽燕

中国药学杂志 ›› 2022, Vol. 57 ›› Issue (10) : 862-866.

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中国药学杂志 ›› 2022, Vol. 57 ›› Issue (10) : 862-866. DOI: 10.11669/cpj.2022.10.015
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江苏省药品临床综合评价项目质量控制指南

  • 张晶晶1,2, 李洪超2, 朱建国1, 李悦1, 马爱霞2*, 缪丽燕1*
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Quality Control Guideline for the Clinical Comprehensive Drugs Evaluation in Jiangsu Province

  • ZHANG Jing-jing, LI Hong-chao, ZHU Jian-guo, LI Yue, MA Ai-xia, MIAO Li-yan
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张晶晶, 李洪超, 朱建国, 李悦, 马爱霞, 缪丽燕. 江苏省药品临床综合评价项目质量控制指南[J]. 中国药学杂志, 2022, 57(10): 862-866 https://doi.org/10.11669/cpj.2022.10.015
ZHANG Jing-jing, LI Hong-chao, ZHU Jian-guo, LI Yue, MA Ai-xia, MIAO Li-yan. Quality Control Guideline for the Clinical Comprehensive Drugs Evaluation in Jiangsu Province[J]. Chinese Pharmaceutical Journal, 2022, 57(10): 862-866 https://doi.org/10.11669/cpj.2022.10.015
中图分类号: R95   

参考文献

[1] NATIONALl HEALTH COMMISSION. Circular of National Health Commission on the monitoring and comprehensive clinical evaluation of drugs(国家卫生健康委关于开展药品使用监测和临床综合评价工作的通知) [EB/OL]. (2019-04-09) [2021-11-23]. http://www.nhc.gov.cn/cms-search/xxgk/getManuscriptXxgk.htm?id=31149bb1845e4c019a 04f30c0d69c2c9.
[2] NATIONALl HEALTH COMMISSION. Circular of the general office of National Health Commission on standardizing comprehensive clinical evaluation of drugs(国家卫生健康委办公厅关于规范开展药品临床综合评价工作的通知) [EB/OL]. (2021-07-28) [2021-11-23]. http://www.nhc.gov.cn/yaozs/s2908/202107/532e20800a47415d84adf3797b0f4869.shtml.
[3] Notice on printing and distributing work plan of comprehensive clinical evaluation of drugs in Jiangsu province (关于印发《江苏省药品临床综合评价工作方案》的通知)[EB/OL]. (2019-11-14) [2021-11-23]. http://www.lyg.gov.cn/zglygzfmhwz/ggws/content/34c810b7-1380-43ef-98a69edb9ea2c7cb.html.
[4] CHINA DRUGS COMPREHENSIVE EVALUATION GUIDELINE PROJECT TEAM. Guideline for comprehensive evaluation of medicine in China(2nd edition) [J]. Drug Eval (药品评价), 2015, 12(8):6-25.
[5] NICE. Technology appraisal guidance[EB/OL]. [2021-11-23]. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance.
[6] CADTH. Health technology review[EB/OL]. [2021-11-23]. https://www.cadth.ca/programs-and-services.
[7] HIGGINS J P, GREEN S. Cochrane Handbook for Systematic Reviews of Interventions[M/OL]. 2008, (2011-03-20) [2021-11-26]. http://www.cochrane.org/training/cochrane-handbook.
[8] BROUWERS M C, KHO M E, BROWMAN G P, et al. AGREE II: advancing guideline development, reporting and evaluation in health care[J]. J Clin Epidemiol, 2010, 63(12): 1308-1311.
[9] HAILEY D. Toward transparency in health technology assessment: a checklist for HTA reports[J]. Int J Technol Assess Health Care, 2003, 19(1):1-7.
[10] SHEA B J, GRIMSHAW J M, WELLS G A, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews[J]. BMC Med Res Methodol, 2007, 7(1):10-17.
[11] HUSEREAU D, DRUMMOND M, PETROU S, et al. Consolidated health economic evaluation reporting standards (CHEERS) statement[J]. Int J Technol Assess Health Care, 2013, 29(2):117-122.
[12] HIGGINS J P, ALTMAN D G, GØTZSCHE P C, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials[J]. BMJ, 2011, 343:d5928. Doi: 10.1136/bmj.d5928.
[13] WELLS G, SHEA B, O'CONNELL J, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses[EB/OL]. 2000, [2021-11-26]. http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp.
[14] SCOTTISH INTERCOLLEGIATE GUIDELINES NETWORK(SIGN). SIGN 50: a guideline developer's handbook[M]. Edinburgh: 2008: 1-56.
[15] Guide for real world research (真实世界研究指南) [S]. 2018:4-27.
[16] Guidelines for real world data for generating real world evidence (trial)《用于产生真实世界证据的真实世界数据指导原则(试行)》[S]. 2021.
[17] Technical guidelines for data management in clinical trials (临床试验数据管理工作技术指南) [S]. 2012:1-37.
[18] FDA. Guidance for industry computerized systems used in clinical trials [EB/OL]. (2015-13-04) [2022-06-01]. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/guidance-industry-computerized-systems-used-clinical-trials.

基金

江苏省卫建委公共卫生与计划生育服务(药品临床综合评价)项目资助(2109999);苏州市科技发展计划(民生科技-医疗卫生应用基础研究)项目资助(SYSD2020181);白求恩公益基金会“白求恩·求索-药学科研能力建设”项目资助(B-19-H-20200622)
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