1. |
U.S. Food & Drug Administration. FDA's Sentinel Initiative 2016. Available at: https://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm.
|
2. |
U.S. Food & Drug Administration. Use of real-world evidence to support regulatory decision- making for medical devices. Available at: https://www.sogou.com/link?url=hedJjaC291MKYTE9c75enrRl1lre67CaI2smYvubWPDFTrmuzC6_HxuOpabFoY9DDAtF2Uxnf-_K7H6UfOzzMu_peCDdarnS0mCuc_NSvjlMb-O2TiRDw9Lmp63ypS7ArUC4tv2Zulat5pUc3zy0dg.
|
3. |
Oyinlola, J O, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv Res, 2016, 16: 299.
|
4. |
Suzuki H, Shimada K, Fujiwara K. Antihypertensive effectiveness of combination therapy with losartan/hydrochlorothiazide for 'real world' management of isolated systolic hypertension. Ther Adv Cardiovasc Dis, 2015, 9(1): 10-18.
|
5. |
Barclay K, Carruthers R, Traboulsee A, et al. Best practices for long-term monitoring and follow-up of alemtuzumab-treated ms patients in real-world clinical settings. Front Neurol, 2019, 10: 253.
|
6. |
Garrison LP, Jr. Neumann PJ, Erickson P, et al. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health, 2007, 10(5): 326-35.
|
7. |
Hiroi S, Sugano K, Tanaka S, et al. Impact of health insurance coverage for Helicobacter pylori gastritis on the trends in eradication therapy in Japan: retrospective observational study and simulation study based on real-world data. BMJ Open, 2017, 7(7): e015855.
|
8. |
Hampson G, Towse A, Dreitlein WB, et al. Real-world evidence for coverage decisions: opportunities and challenges. J Comp Eff Res, 2018, 7(12): 1133-1143.
|
9. |
Stang PE, Ryan PB, Racoosin JA, et al. Advancing the science for active surveillance: rationale and design for the observational medical outcomes partnership. Ann Intern Med, 2010, 153(9): 600-606.
|
10. |
U.S. Food & Drug Administration. Framework for FDA's real world evidence program. Available at: https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RealWorldEvidence/UCM627769.pdf.
|
11. |
U.S. Food & Drug Administration. Best practice for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data. Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM243537.pdf.
|
12. |
Sun X, Li Y, Guyatt G. Available at: https://blogs.bmj.com/bmj/2018/11/06/production-of-trustworthy-real-world-data-and-evidence-in-china/.
|
13. |
贝伐珠单抗又有新适应症获批, 真实世界数据为其提供新思路. Available at: https://www.sohu.com/a/273433437_564028.
|
14. |
Sun X, Tan J, Tang L, et al. Real world evidence: experience and lessons from China. BMJ, 2018, 360: j5262.
|
15. |
国家药品监督管理局. 关于政协十三届全国委员会第一次会议第2489号(医疗体育类247号)提案答复的函. Available at: http://www.nmpa.gov.cn/WS04/CL2141/331878.html.
|
16. |
Han, S, Jeong HS, Kim H, et al. The treatment pattern and adherence to direct oral anticoagulants in patients with atrial fibrillation aged over 65. PLoS One, 2019, 14(4): e0214666.
|
17. |
U.S. Food & Drug Administration. Guidance for Industry and FDA Staff: Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials. Available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu ments/ucm071121.pdf.
|
18. |
Find Drugs & Conditions. Ibrance approval expanded to include men with breast cancer. Available at: https://www.drugs.com/news/ibrance-approval-expanded-include-men-breast-cancer-81595.html.
|
19. |
Resnic FS, Majithia A, Marinac-Dabic D, et al. Registry-based prospective, active surveillance of medical-device safety. N Engl J Med, 2017, 376(6): 526-535.
|
20. |
中华人民共和国卫生部. 药品不良反应报告和监测管理办法(卫生部令第81号). Available at: http://www.sda.gov.cn/WS01/CL0053/62621.html.
|
21. |
国家食品药品监督管理总局安监司. 关于征求《关于推动生产企业开展药品重点监测工作的通知( 征求意见稿) 》意见的函. Available at: http://www.cfda.gov.cn/WS01/CL0778/79321.html.
|
22. |
孙鑫, 谭婧, 唐立, 等. 基于真实世界证据的上市后药品评价技术框架体系: 思考与建议. 中国循证医学杂志, 2018, 18(4): 277-283.
|
23. |
谭婧, 程亮亮, 王雯, 等. 患者登记研究的策划与患者登记数据库构建: 基于观察性设计的真实世界研究. 中国循证医学杂志, 2017, 17(12): 1-8.
|
24. |
U.S. Food and Drug Administration. Exenatide (marketed as BYETTA): Acute Pancreatitis. Available at: http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/ucm119034.htm#exenatide.
|
25. |
Dore DD, Bloomgren GL, Wenten M, et al. A cohort study of acute pancreatitis in relation to exenatide use. Diabetes Obes Metab, 2011, 13(6): 559-66.
|
26. |
孙鑫, 谭婧, 唐立, 等. 重新认识真实世界研究. 中国循证医学杂志, 2017, 17(2): 126-130.
|
27. |
王雯, 刘艳梅, 谭婧, 等. 回顾性数据库研究的概念, 策划与研究数据库构建. 中国循证医学杂志, 2018, 18(2): 1365-1372.
|
28. |
唐立, 康德英, 喻佳洁, 等. 实效性随机对照试验: 真实世界研究的重要设计. 中国循证医学杂志, 2017, 2017(17): 999-1004.
|
29. |
李洪, 魏来, 郭晓蕙, 等. 真实世界研究伦理审查初探. 中国循证医学杂志, 2018, 18(11): 1198-1202.
|
30. |
王雯, 谭婧, 于川, 等. 基于中国医院电子病历数据的药品安全性评价模式探索. 中国药物警戒, 2019, 16(3): 134-138.
|