Communicating the benefits and harms of anticancer drugs
A partir d'une revue des informations écrites émanant de sources réglementées et portant sur 29 médicaments anticancéreux ayant reçu une première autorisation de mise sur le marché par l'Agence européenne des médicaments (EMA) sur la période 2017-2019 (32 indications), cette étude évalue la fréquence à laquelle des informations pertinentes et précises sur les avantages et les incertitudes liées à ces médicaments sont communiquées aux patients et aux cliniciens
Informed consent is a central tenet of ethical clinical practice and shared decision making, and it requires that patients have easy access to independent and comprehensive information about medicines. For instance, is accurate information about benefits and harms available, is it complete, and is it presented in ways that ensure patients understand the benefits and harms from key research findings and the extent of remaining uncertainties? In a linked paper, Davis and colleagues (doi:10.1136/bmj-2022-073711) set out to answer these questions for new anticancer drugs approved by the European Medicines Agency (EMA) between 2017 and 2019.1 Firstly, they evaluated the content of European public assessment reports (EPARs), looking at information targeted at clinicians (through a summary of product characteristics), patients (information leaflets), and the public (public summaries). Then they used a non-systematic review of literature, UK and EU guidance documents, frameworks, and taxonomies to determine what information about drug benefits and harms is most important to patients and the public. Their findings suggest that there is much room for improvement in the sources provided, particularly in patient information leaflets.