Refinement of Operating Characteristics for Model‐Based TGI Metrics Decision Support to Ungate a Pivotal Trial in Oncology

The oncology market is evolving, with an increasing number of therapeutic options making the inference of treatment benefit from early development critical. The "Go" versus "No Go" decisions from such trials usually rely on probabilities of achieving meaningful improvements (effect sizes) in endpoints like objective response rate, tailored to products' profile, supporting faster transitions to confirmatory trials. Operating characteristics are sensitive to methodological details, important for establishing an early decision framework for ungating a pivotal clinical trial.