Safety reporting in randomized clinical trials - a need for improvement.

  • Yusuf Yazici
  • Published 2009 in Bulletin of the NYU hospital for joint diseases

Abstract

The reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking in the publication of trials. Part of the problem is the way safety data are reported in RCTs. Reporting of "time to event," use of standardized incidence ratios for comparison to normal population or disease controls, use of "patient years" when reporting AE, and… (More)

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