Real-world evidence and randomized controlled trials: the initiation, implementation, progress interpretation and revelation of RCT DUPLICATE (part 2).
10.3760/cma.j.cn112338-20220513-00409
- Author:
Shu Yuan SHI
1
;
Zuo Xiang LIU
2
;
Hou Yu ZHAO
2
;
Xiao Lu NIE
3
;
Sheng HAN
4
;
Zhu FU
5
;
Hai Bo SONG
6
;
Chen YAO
7
;
Si Yan ZHAN
8
;
Feng SUN
9
Author Information
1. Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China China Institute of Rehabilitation Sciences, Center for Prevention and Control of Disability of China Disabled Persons Federation, Beijing 100068, China.
2. Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China.
3. Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China.
4. Department of Pharmacy Management and Clinical Pharmacy, Peking University School of Pharmacy, Beijing 100191, China.
5. Hainan Institute of Real World Data, the Admonistration of Boao Lecheng International Medical Tourism Pilot Zone, Lecheng 571437, China.
6. Center for Drug Reevaluation, National Medical Products Administration, Beijing 100022, China Key Laboratory for Research and Evaluation of Pharmacovigilance, National Medical Products Administration, Beijing 100022, China.
7. Hainan Institute of Real World Data, the Admonistration of Boao Lecheng International Medical Tourism Pilot Zone, Lecheng 571437, China Peking University Clinical Research Institute, Beijing 100191, China.
8. Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China Clinical Epidemiology Research Center, Peking University Third Hospital, Beijing 100191, China.
9. Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China Hainan Institute of Real World Data, the Admonistration of Boao Lecheng International Medical Tourism Pilot Zone, Lecheng 571437, China.
- Publication Type:Journal Article
- MeSH:
Humans;
Randomized Controlled Trials as Topic;
Cognition;
Big Data;
Universities
- From:
Chinese Journal of Epidemiology
2022;43(11):1835-1841
- CountryChina
- Language:Chinese
-
Abstract:
With the promotion and application of big medical data, non-interventional real-world evidence (RWE) has been used by regulators to assess the effectiveness of medical products. This paper briefly introduces the latest progress and research results of the RCT DUPLICATE Initiative launched by the research team of Harvard University in 2018 and summarizes relevant research experience based on the characteristics of China's medical service to provide inspiration and reference for domestic scholars to conduct related RWE research in the future.
