Letters Post-marketing safety studies

Three design aspects for high quality post-marketing cohort studies

BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j1851 (Published 12 April 2017) Cite this as: BMJ 2017;357:j1851
  1. Michael Fralick, general internist and research fellow,
  2. Aaron S Kesselheim, associate professor of medicine, Harvard Medical School
  1. Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA 02120, USA
  1. mif823{at}mail.harvard.edu

Spelsberg and colleagues showed that ascertaining the results of post-marketing safety studies is challenging.1 In the US and Europe, brand name drug manufacturers are required to summarise data from post-marketing studies and submit them to the regulatory authority.2 Aspects of these reports should be made publicly available to inform the medical community about important emerging data and allow the scientific community to evaluate …

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