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Reporting of Drug Tolerance in Randomized Clinical Trials: When Data Conflict with Authors' Conclusions
- Annie Pierre Jonville-Béra, MD;
- Bruno Giraudeau, PhD; and
- Elisabeth Autret-Leca, MD
- From University Hospital of Tours, 37044 Tours, France.
TO THE EDITOR:
Background: Double-blind randomized trials that compare the efficacy of a new drug with an older drug or with placebo also often provide information regarding safety. When these findings are published, some authors conclude that the new drug has a “good safety profile” just because they failed to find any statistical difference in frequencies of adverse effects.
Objective: The goal of this study is to illustrate this misreporting of data and to propose parameters that would promote more objective reports of safety results.
Methods: We selected 2 published clinical trials (1, 2) that compared pharmacologic treatments for which the authors clearly stated that there was no difference in the occurrence of adverse effects. We …
