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

OriginalPaper | Updated：2021-08-27

- Design and analysis of post-marketing research
- Design and analysis of post-marketing research
- 中国结合医学杂志（英文版） 2013年19卷第7期页码：488-493
- 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
  中图分类号：
- 纸质出版日期：2013，
  
  网络出版日期：2013-7-2，
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, 2013,19(7):488-493.
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, 2013,19(7):488-493. 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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