Temporal Patterns and Factors Associated with Early Termination in Phase 1 Clinical Trials for Solid Tumors
Giovanni Maria Iannantuono·G. Daniele·Marco Filetti·Elena Giudice·Gloria Messina·Anna Ceccarelli·James L. Gulley·Alessandra Fabi·Luisa Carbognin·Martina Mazzuferi·Roberto Rosenfeld·Pasquale Lombardi·Alessandro Rossi·Valeria Altamura·Giuliano Maiolatesi·Alberto Gatto·Emilio Bria·Antonio Vitale·Charalampos S. Floudas·Francesca Lo Bianco·Andrea Spinazzola·Tommaso Giovagnoli·Luca Mastrantoni·S. Sganga·Diana Giannarelli
Phase 1 trials are primarily discontinued for "sponsor/strategic decisions". Funding source, tumor type, and geographic location of recruiting centers are independently associated with ET. The early peak in ET probability marks a critical window for interventions to improve trial sustainability.