Data on adverse events in clinical study reports may not accurately represent underlying patient data, according to two pilot studies in the British Medical Journal, the first from a team lead by Peter Gøtzsche analyzing unredacted clinical study reports and protocols from the European Medicines Association before it closed in 2011. The team is finding that clinical study reports contain extensive data on major harms that are not made available in journal articles and trial registry reports.
Maund, E., Tendal, B., Hróbjartsson, A., Lundh, A., Gøtzsche, P. Coding of adverse events of suicidality in clinical study reports of duloxetine. British Medical Journal. June 4, 2014; 348:g3555. doi: 10.1136/bmj.g3555
Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications. British Medical Journal. June 4, 2014; 348:g3510 doi: 10.1136/bmj.g3510
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