真实世界证据支持药物研发与审评的指导原则(试行)(国家药监局通告2020年第1号) .. ...

2023-2-12 13:36| 发布者: 医智宝| 查看: 1366| 评论: 0

摘要: 《真实世界证据支持药物研发与审评的指导原则(试行)》的起草说明 附录:1.真实世界研究有关词汇表,2.真实世界证据应用示例,3.真实世界研究常用统计分析方法,4.真实世界研究有关中英文词汇对照 ...


【参考文献

1.孙宇昕,魏芬芳,杨悦. 真实世界证据用于药械监管与卫生决策的机遇与挑战. 中国药物警戒,2017,14(6):353-358.

2.吴一龙,陈晓媛,杨志敏等(吴阶平医学基金会,中国胸部肿瘤研究协作组). 真实世界研究指南. 2018.

3.中共中央办公厅,国务院办公厅. 关于深化审评审批制度改革鼓励药品医疗器械创新的意见. 2017.

4.ADAPTABLE Investigators. Aspirin Dosing: a Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE)study protocol. http://pcornet. org/wp-content/uploads/2015 /06/ADAPTABLE-Protocol-Final-Draft-6-4-15_for-post_06-26-. pdf[J]. Published June,2015,5.

5.Berger M,Daniel G,Frank K,et al. A frame work for regulatory use of real-world evidence[J]. White paper prepared by the Duke Margolis Center for Health Policy,2017,6.

6.Cave A,Kurz X,Arlett P. Real-world data for regulatory decision making: challenges and possible solutions for europe[J]. Clinical pharmacology and therapeutics,2019,106(1): 36.

7.Dreyer NA. Advancing a framework for regulatory use of real-world evidence: when real is reliable[J]. Therapeutic innovation & regulatory science,2018,52(3): 362-368.

8.Egger M,Moons K G M,Fletcher C,et al. GetReal: from efficacy in clinical trials to relative effectiveness in the real world[J]. Research synthesis methods,2016,7(3): 278-281.

9.Ford I,Norrie J. Pragmatic trials[J]. N Engl J Med,2016,375(5): 454-463.

10.Institute of Medicine 2009. Initial national priorities for comparative effectiveness research. Washington,DC: The National Academies Press. https://doi.org/10.17226/12648.

11.James S. Importance of post-approval real-word evidence[J]. European Heart Journal-Cardiovascular Pharmacotherapy,2018; 4(1):10-11.

12.Kohl S. Joint HMA/EMA task force on big data established[J]. Eur J Hosp Pharm,2017,24(3): 180-190.

13.Lash TL,Fox MP,Fink AK. Applying quantitative bias analysis to epidemiologic data[M]. Springer Science & Business Media,2011.

14.Makady A,de Boer A,Hillege H,et al. What is real-world data? A review of definitions based on literature and stakeholder interviews[J]. Value in health,2017,20(7): 858-865.

15.Olariu E,Papageorgakopoulou C,Bovens S M,et al. Real world evidence in Europe: a snapshot of its current status[J]. Value in Health,2016,19(7): A498.

16.Roland M,Torgerson D J. Understanding controlled trials: What are pragmatic trials?[J]. BMJ,1998,316(7127): 285.

17.Sherman RE,Anderson SA,Dal Pan GJ,et al. Real-world evidence—what is it and what can it tell us[J]. N Engl J Med2016,375(23): 2293-2297.

18.Sugarman J,Califf RM. Ethics and regulatory complexities for pragmatic clinical trials[J]. JAMA,2014,311(23): 2381-2382.

19.US Food and Drug Administration. Framework for FDA’s real-world evidence program. December 2018[J]. 2019.

20.Velentgas P,Dreyer NA,Nourjah P,Smith SR,Torchia MM,eds. Developing a Protocol for Observational Comparative Effectiveness Research: A User’s Guide. AHRQ Publication No. 12(13)-EHC099. Rockville,MD: Agency for Healthcare Research and Quality; January 2013. www.effectivehealthcare.ahrq.gov/ Methods-OCER.cfm.

21.Von Elm E,Altman D G,Egger M,et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)statement: guidelines for reporting observational studies[J]. Annals of internal medicine,2007,147(8): 573-577.

 

附录:1.真实世界研究有关词汇表

2.真实世界证据应用示例

3.真实世界研究常用统计分析方法

4.真实世界研究有关中英文词汇对照

 



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