Registration of Observational Studies: perspectives from an industry-based epidemiology group

Pharmacoepidemiol Drug Saf. 2011 Oct;20(10):1009-13. doi: 10.1002/pds.2221. Epub 2011 Aug 25.


Registration of randomized clinical trials has become standard practice and is enforced through publication policies and governmental regulations. However, the registration of observational studies remains controversial. In this commentary, we propose that a compromise can be reached on which observation should be registered based on study design and study intent.

MeSH terms

  • Drug Industry / ethics
  • Drug Industry / legislation & jurisprudence*
  • Drug Industry / standards*
  • Epidemiologic Studies*
  • Humans
  • Observation
  • Randomized Controlled Trials as Topic
  • Research Design