Design and analysis of post-marketing research

Xiao-Hua Andrew Zhou; Wei Yang

doi:10.1007/s11655-013-1501-z

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Design and analysis of post-marketing research

Updated：2021-08-27

- Design and analysis of post-marketing research
- Chinese Journal of Integrative Medicine Vol. 19, Issue 7, Pages: 488-493(2013)
- Affiliations：
  
  1. Department of Biostatistics, School of Public Health, University of Washington,Washington,USA
  2. School of Statistics, Renmin University of China,Beijing,China
  3. Biostatistics Unit, VA Seattle Medical Center,Seattle,USA
  4. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences,Beijing,China
- Author bio：
- Funds：
  
  Supported by the Research on Key Techniques of Reevaluation of Post-marketing Chinese Medicine, the Ministry of Science and Technology (No. 2009ZX09502-030) and the Sixth-Science Foundation of Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences (Grant No. Z0215) and the Seventh-Science Foundation of Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences (Grant No. Z0255)
- DOI：10.1007/s11655-013-1501-z
  CLC：
- Published：2013，
  
  Published Online：2 July 2013，
Scan for full text
Zhou, XH.A., Yang, W. Design and analysis of post-marketing research., Chin. J. Integr. Med. 19, 488–493 (2013). https://doi.org/10.1007/s11655-013-1501-z

Xiao-Hua Andrew Zhou, Wei Yang. Design and analysis of post-marketing research. [J]. Chinese Journal of Integrative Medicine 19(7):488-493(2013)
Zhou, XH.A., Yang, W. Design and analysis of post-marketing research., Chin. J. Integr. Med. 19, 488–493 (2013). https://doi.org/10.1007/s11655-013-1501-z DOI：

Xiao-Hua Andrew Zhou, Wei Yang. Design and analysis of post-marketing research. [J]. Chinese Journal of Integrative Medicine 19(7):488-493(2013) DOI： 10.1007/s11655-013-1501-z.

摘要

A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs

which are liable to confounding

estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs

especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed

and recommendations are given for improving the validity of postmarketing studies in TCM products.

Abstract

which are liable to confounding

especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed

and recommendations are given for improving the validity of postmarketing studies in TCM products.

关键词

traditional Chinese medicine post-marketing researchsafety surveillancepharmacovigilance methodspropensity score

Keywords

traditional Chinese medicine post-marketing researchsafety surveillancepharmacovigilance methodspropensity score

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