Brian Hondorp, Nihal Punjabi, David Macias, Yuan Liu, Ethan Frank, Paul D Kim, Jared C Inman
Patterns of Discordance Between Clinical and Pathologic Stage in Head and Neck Cancer
The Laryngoscope
generalizability registrative clinical trials realworld clinical practice influenced comparability patients two settings compared characteristics cancer patients registrative trials realworld clinical practice italy data age sex performance status ps derived webbased monitoring registries developed italian medicines agency aifa corresponding registrative trials reported european public assessment reports epar european medicines agency ema weighted means calculated registries trials differences described multivariate analysis performed using principal component analysis cluster analysis january 2013 april 2023 419461 unique pairs patients therapeutic indications recorded 129 aifa registries within 140 related trials 87452 patients enrolled median age rate elderly 65 years old patients higher monitoring registries clinical trials mean difference median age 53 years p 0001 mean difference elderly rate 1717 95 ci 106 148 overall rate female patients different registries trials mean difference 055 95 ci 106 005 mean rate patients deteriorated ps low trials 31 registries 43 mean difference 127 95 ci 106 148 two clusters identified multivariate analysis one including registries higher median age elderly rate lower female rate higher rate deteriorated patients trials lower median age elderly rate higher female rate lower rate deteriorated patients study supports cancer patients enrolled trials partially represent treated italy clinical practice inclusiveness registrative trials increased ensure generalizability results realworld population partially supported italian ministry health