Progress in the application of clinical evidence in health decision-making: experience from NICE in the UK_Chinese Journal of Evidence-Based Medicine

Authors：

TIAN Lei , XU He , MENG Rui ,  MA Aixia

School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, P.R.China;

Corresponding author：

MA Aixia, Email: aixiama73@126.com

Keywords：

Randomized controlled trials; Non-randomized controlled trials; Real-world study; Health decisions

DOI：

10.7507/1672-2531.201909026

Video：

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Traditional randomized controlled trial and real-world study have different advantages in internal validity and external extensibility, respectively. With the development of evidence-based health decisions, randomized controlled trial was no longer the only golden standard of interventional study, the research evidence of the real world was gradually involved in health decisions. This study mainly analyzed the requirements of evidence and actual application of evidence in the evaluation of the effectiveness of NICE in the UK. It was found that NICE still used the results of randomized controlled trials as a primary basis. Although real-world research has developed rapidly in recent years, it was limited used in health decision because of its bias by design and other factors. However, in recent years, real-world evidence has played a significant role in the field of innovative drugs or diseases that lack therapeutic drugs. With the improvement of real-world research in experimental design and data analysis, it is expected that it will play a more important role in health decision-making.

Citation： TIAN Lei, XU He, MENG Rui, MA Aixia. Progress in the application of clinical evidence in health decision-making: experience from NICE in the UK. Chinese Journal of Evidence-Based Medicine, 2020, 20(1): 112-118. doi: 10.7507/1672-2531.201909026 Copy

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1. 中国药品综合评价指南项目组. 中国药品综合评价指南参考大纲(第2版). 药品评价, 2015, 12(8): 6.
2. 李洪, 张玉丽, 谢诗桐, 等. 我国医疗保险目录准入申报材料递交的思考与建议-以高血压复方制剂为例. 中国药物经济学, 2018, 13(7): 18-23.
3. CADTH. Resubmission criteria for the CADTH Common Drug Review. Available at: https://cadth.ca/media/cdr/process/CADTH_CDR_Resubmission_Criteria.pdf.
4. 姚嘉奇, 周挺, 管欣, 等. 英国NICE卫生技术评估介绍及对我国医保目录动态调整的启示. 中国循证医学杂志, 2018, 18(9): 984-989.
5. NICE. NICE technology appraisal guidance. Available at: https://www.nice.org.uk/About/What-we-do/Our-Programmes/NICE-guidance/NICE-technology-appraisal-guidance.
6. NICE. Our programmes. Available at: https://www.nice.org.uk/about/what-we-do/our-programmes.
7. NICE. NICE guidelines. Available at: https://www.nice.org.uk/About/What-we-do/Our-Programmes/NICE-guidance/NICE-guidelines.
8. NICE. Technology appraisal processes. Available at: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/process.
9. NICE. Guide to the processes of technology appraisal. London: National Institute for Health and Care Excellence, 2014.
10. NICE. Guide to the methods of technology appraisal 2013. London: National Institute for Health and Care Excellence, 2013.
11. Gorrod HB, Hernandez M, Grieve R. The use of real world data for the estimation of treatment effects in NICE decision making. London: National Institute for Health and Care Excellence, 2016.
12. NICE. Developing NICE Guidelines: The Manual. London: National Institute for Health and Care Excellence, 2015.
13. NICE. Interventional Procedures Programme Manual. London: National Institute for Health and Care Excellence, 2016.
14. NICE. Diagnostics Assessment Programme Manual. London: National Institute for Health and Care Excellence, 2011.
15. 田磊, 管欣, 马爱霞. 随机对照试验研究与观察性研究的系统比较. 中国药房, 2018, 29(4): 493-496.
16. 李强. 临床疗效研究的金方案:随机对照试验. 世界华人消化杂志, 1999, 7(8): 697-698.
17. 吴宏涛, 周东, 何俐. 非随机对照试验的意义. 中国循证医学杂志, 2004, 4(8): 570-572.
18. NICE. Single technology appraisal: User guide for company evidence submission template. London: National Institute for Health and Care Excellence, 2015.
19. Centre for Reviews and Dissemination. CRD's guidance for undertaking reviews in health care. York: York Publishing Services Ltd, 2009.
20. 田磊, 岳彩宾, 管欣, 等. 真实世界研究与随机对照试验在临床实践及卫生决策中应用的比较. 中国医院药学杂志, 2019, 39(3): 274-277.
21. 袁林, 邵明立. 美国FDA加快新药审评策略以及对我国的启示. 中国新药杂志, 2015, 24(21): 2401-2404.
22. 李小芳, 戴伟民, 宋永飞. 对我国药品优先审评审批制度的分析和思考. 中国医药工业杂志, 2019, 50(7): 796-802.
23. 孙鑫, 谭婧, 王雯, 等. 真实世界证据助推药械评价与监管决策. 中国循证医学杂志, 2019, 19(5): 521-526.
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Progress in the application of clinical evidence in health decision-making: experience from NICE in the UK

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