Real-world evidence and randomized controlled trials: the initiation, implementation, progress interpretation and revelation of RCT DUPLICATE (part 1).
10.3760/cma.j.cn112338-20220513-00408
- Author:
Shu Yuan SHI
1
;
Zuo Xiang LIU
2
;
Hou Yu ZHAO
2
;
Xiao Lu NIE
3
;
Zhu FU
4
;
Hai Bo SONG
5
;
Chen YAO
6
;
Si Yan ZHAN
7
;
Feng SUN
8
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. Hainan Institute of Real World Data, the Admonistration of Boao Lecheng International Medical Tourism Pilot Zone, Lecheng 571437, China.
5. 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.
6. 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.
7. 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.
8. 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;
Databases, Factual;
Research Personnel;
Universities
- From:Chinese Journal of Epidemiology
2022;43(11):1828-1834
- CountryChina
- Language:Chinese
-
Abstract:
In recent years, researchers, pharmaceutical companies, and political makers gradually using more real-world data (RWD) to produce real-world evidence (RWE) for policy-making. A research team of Harvard University launched the RCT DUPLICATE project in 2018, aiming to replicate 30 randomized controlled trials using the medical claims database in order to explore methods for quantifying the efficacy-effectiveness gap and explain its potential sources, to enhance the credibility of the RWE. This paper reviews the background of RCT DUPLICATE Initiative, highlights the research purposes, research design and implementation process of the RCT DUPLICATE Initiative, to help domestic scholars better understand the scope and application value of RWE.
