Letters Post-marketing studies

Post-marketing studies can make important contributions to medical knowledge

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e4740 (Published 16 July 2012) Cite this as: BMJ 2012;345:e4740
  1. Martin C Michel, clinical pharmacologist1
  1. 1Institut für Pharmakologie, Johannes Gutenberg Universität, 55101 Mainz, Germany
  1. martin.michel{at}boehringer-ingelheim.com

My experience in collaborating with various drug companies in the design, execution, analysis, and publication of post-marketing surveillance (PMS) studies differs greatly from that described in your recent article.1 The general consensus was that PMS studies serve a scientific purpose. Studies typically had predefined scientific questions and were powered to answer them. Some studies had been recommended by the regulatory authorities, such …

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