Advancing Assessment, Analysis, and Reporting of Safety and Tolerability in Cancer Trials
Menée à partir des données de 7 essais cliniques de phase III incluant au total 9 215 patients atteints d'un cancer de la prostate de stade avancé traité par apalutamide, enzalutamide ou darolutamide, cette étude identifie les différents types d'événements secondaires reportés, analyse l'homogénéité des données collectées et examine la qualité des analyses statistiques effectuées
In this issue of JNCI,Drago and colleagues analyzepublished safety resultsto gaininsightsinto comparative drug safety across randomizedprostate cancertrials.1Weapplaud the authors fortackling an important andchallenging topic. Whilecross-trial comparisonsare problematic, US Food and Drug Administration (FDA)product labeling andpublished literatureare often used toguide shared decision making when discussing treatment options with patients. Importantly, the Drago article highlightsthe complexity of safety data, andthe substantial risk of misinterpretation when attempting to comparesafety across independently conducted trials.
Journal of the National Cancer Institute , éditorial en libre accès, 2019