Expert consensus on design and statistical analysis to evaluate drug safety using routinely collected health data

doi:10.19803/j.1672-8629.2022.01.02

Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (1): 7-12.
DOI: 10.19803/j.1672-8629.2022.01.02

Expert consensus on design and statistical analysis to evaluate drug safety using routinely collected health data

WANG Wen^1,2, LIU Mei^1,2, HE Qiao^1,2, TIAN Chunhua³, SONG Haibo³, WANG Tao³, TAN Jing^1,2, REN Yan^1,2, GAO Pei⁴, PENG Xiaoxia⁵, WEN Zehuai⁶, SHU Xiaochen⁷, ZOU Kang^1,2, SHEN Chuanyong^3#, SUN Xin^1,2,*

¹Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu Sichuan 610041, China;
²NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Haikou Hainan 570100, China;
³Center for Drug Reevaluation, NMPA/NMPA, Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China;
⁴Department of Epidemiology and Biostatistics, Peking University Health Science Center, Beijing 100191, China;
⁵Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China;
⁶Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou Guangdong 510120, China;
⁷Department of Epidemiology and Biostatistics, School of Public Health, Medical College Soochow University, Suzhou Jiangsu 215123, China

Received:2021-09-30 Online:2022-01-15 Published:2022-01-20

Abstract

Abstract: As an important source for real world data, routinely collected health data (RCD) have been widely used for drug safety evaluation. However, the production of trustworthy evidence informing drug safety regulatory decision still have substantial challenges, such as inadequate research capacity in design and analysis. In this expert consensus, we introduced the concept and applications of RCD in drug safety evaluation; summarize the issues and proposed recommendations for study design and analysis. We hope this paper may improve the quality of production and use of evidence generating from RCD.

Key words: real world data, drug safety evaluation, routinely collected health data

CLC Number:

R994.11

WANG Wen, LIU Mei, HE Qiao, TIAN Chunhua, SONG Haibo, WANG Tao, TAN Jing, REN Yan, GAO Pei, PENG Xiaoxia, WEN Zehuai, SHU Xiaochen, ZOU Kang, SHEN Chuanyong, SUN Xin. Expert consensus on design and statistical analysis to evaluate drug safety using routinely collected health data[J]. Chinese Journal of Pharmacovigilance, 2022, 19(1): 7-12.

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Expert consensus on design and statistical analysis to evaluate drug safety using routinely collected health data

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