Changes to Primary End Points in Randomized Clinical Trials on Immune Checkpoint Inhibitors in Urothelial, Renal Cell, and Lung Cancers: A Systematic Review

A partir d'une revue systématique, cette étude analyse la fréquence des changements de critères de jugement principaux dans les essais cliniques randomisés évaluant des inhibiteurs de point de contrôle immunitaire pour les cancers urothéliaux, les cancers à cellules rénales et les cancers du poumon puis examine le signalement de ces changements dans les rapports

Résumé en anglais

Programmed cell death 1/programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitors (ICIs) are important treatment options for many cancer types. Urologic and lung cancers have early and multiple Food and Drug Administration (FDA) and European Medicines Agency–approved ICIs based on randomized clinical trials (RCTs). To weigh the strength of evidence, readers need complete and transparent information on design and methodology facilitated by mandatory RCT registration and adherence to CONSORT reporting guidelines. We assessed how often primary end points in RCTs of ICIs were changed and the extent to which these changes were reported.