Utilization of real-world evidence in clinical research of medical devices_Chinese Journal of Evidence-Based Medicine

Authors：

HUANG Yafang ¹ , YAN Xiaoyan ² , LI Xueying ³ ,  YAO Chen ^2,3

1. School of General Practice and Continuing Education, Capital Medical University, Beijing, 100069, P.R.China;
2. Clinical Research Institute, Peking University, Beijing, 100191, P.R.China;
3. First Hospital, Peking University, Beijing, 100034, P.R.China;

Corresponding author：

YAO Chen, Email: yaochen@hsc.pku.edu.cn

Keywords：

Real-world data; Real-world evidence; Medical device; Applicable condition

DOI：

10.7507/1672-2531.201711090

Video：

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Real-world data (RWD) in clinical research on specific categories of medical devices can generate sufficient quality evidence which will be used in decision making. This paper discusses the limitations of traditional randomized controlled trials in clinical research of medical devices, summarizes and analyses the applicable conditions of real-world evidence (RWE) for medical devices, interprets the new FDA guidance document on the characteristics of RWD for medical devices, in order to provide evidence for the use of RWE in medical devices in our country.

Citation： HUANG Yafang, YAN Xiaoyan, LI Xueying, YAO Chen. Utilization of real-world evidence in clinical research of medical devices. Chinese Journal of Evidence-Based Medicine, 2017, 17(12): 1373-1377. doi: 10.7507/1672-2531.201711090 Copy

1.	Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Use of real-world evidence to support regulatory decision-making for medical devices. Guidance for industry and food and drug administration staff. Available at: https://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM513027.
2.	James S, Rao SV, Granger CB. Registry-based randomized clinical trials-a new clinical trial paradigm. Nat Rev Cardiol, 2015, 12(5): 312-316.
3.	Lauer MS, D'Agostino RBS. The randomized registry trial-the next disruptive technology in clinical research? N Engl J Med, 2013, 369(17): 1579-1581.
4.	Sherman RE, Steven A, Dal Pan GJ, et al. Real-World Evidence-What is it and what can it tell us? N Engl J Med, 2016, 375(23): 2293-2297.
5.	Hill AB. Observation and experiment. N Engl J Med, 1953, 248(24): 995-1001.
6.	唐金陵, 杨祖耀. 观察与实验效力与效果. 中华流行病学杂志, 2014, 35(3): 221-227.
7.	Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med, 2000, 342(25): 1887-1892.
8.	Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Design considerations for pivotal clinical investigations for medical devices. Guidance for industry, clinical investigators, institutional review boards and food and drug administration staff. Available at: https://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm373750.htm.
9.	Grapow MT, von Wattenwyl R, Guller U, et al. Randomized controlled trials do not reflect reality: real-world analyses are critical for treatment guidelines! J Thorac Cardiovasc Surg, 2006, 132(1): 5-7.
10.	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, 17(9): 999-1004.
11.	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.
12.	唐金陵, 杨祖耀, 毛琛. 大型随机对照试验:精准流行病学研究的典范与陷阱. 中华流行病学杂志, 2017, 38(10): 1299-1304.
13.	Glasziou P, Chalmers I, Rawlins M, et al. When are randomized trials unnecessary? Picking signal from noise. BMJ, 2007, 334(7589): 349-351.

1. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Use of real-world evidence to support regulatory decision-making for medical devices. Guidance for industry and food and drug administration staff. Available at: https://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM513027.
2. James S, Rao SV, Granger CB. Registry-based randomized clinical trials-a new clinical trial paradigm. Nat Rev Cardiol, 2015, 12(5): 312-316.
3. Lauer MS, D'Agostino RBS. The randomized registry trial-the next disruptive technology in clinical research? N Engl J Med, 2013, 369(17): 1579-1581.
4. Sherman RE, Steven A, Dal Pan GJ, et al. Real-World Evidence-What is it and what can it tell us? N Engl J Med, 2016, 375(23): 2293-2297.
5. Hill AB. Observation and experiment. N Engl J Med, 1953, 248(24): 995-1001.
6. 唐金陵, 杨祖耀. 观察与实验效力与效果. 中华流行病学杂志, 2014, 35(3): 221-227.
7. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med, 2000, 342(25): 1887-1892.
8. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Design considerations for pivotal clinical investigations for medical devices. Guidance for industry, clinical investigators, institutional review boards and food and drug administration staff. Available at: https://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm373750.htm.
9. Grapow MT, von Wattenwyl R, Guller U, et al. Randomized controlled trials do not reflect reality: real-world analyses are critical for treatment guidelines! J Thorac Cardiovasc Surg, 2006, 132(1): 5-7.
10. 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, 17(9): 999-1004.
11. 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.
12. 唐金陵, 杨祖耀, 毛琛. 大型随机对照试验:精准流行病学研究的典范与陷阱. 中华流行病学杂志, 2017, 38(10): 1299-1304.
13. Glasziou P, Chalmers I, Rawlins M, et al. When are randomized trials unnecessary? Picking signal from noise. BMJ, 2007, 334(7589): 349-351.

Chinese Journal of Evidence-Based Medicine

Utilization of real-world evidence in clinical research of medical devices

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