Comparison of baseline patient characteristics in phase 1 and phase 2/3 clinical trials for anticancer treatments

Comparison of baseline patient characteristics in phase 1 and phase 2/3 clinical trials for anticancer treatments. Maria Lucia Iacovino, Simone Talucci, Laura Arenare, Andrea Caglio, Andrea Canciello, Flavio Salerno, Sergio Facchini, Adriano Gravina, Clorinda Schettino, Maria Carmela Piccirillo, Pierpaolo Olimpieri, Massimo Di Maio, Francesco Perrone Characteristics of patients significantly differ between registrational trials and Italian real-world practice, with older median age, higher rate of elderly (≥ 65 years old) and worse performance status (PS) in the latter, without imbalance in female rate. Here we compare the same patient characteristics between registrational phase 2/3 and phase 1 clinical trials (CTs).