Reports of clinical trials usually emphasize efficacy results, especially when results are statistically significant. Poor safety reporting can lead to misinterpretation and inadequate conclusions about the interventions assessed. Our aim was to describe the reporting of harm-related results from randomized controlled trials (RCTs).
Département d'Epidémiologie, Biostatistique, et Recherche Clinique, Groupe Hospitalier Bichat-Claude Bernard (AP-HP), Université Denis Diderot, INSERM U738, Paris, France.