Refinement of Operating Characteristics for Model‐Based <scp>TGI</scp> 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.
Authors
- António Gonçalves (ORCID: https://orcid.org/0000-0002-8759-2429)
- Pascal Chanu (ORCID: https://orcid.org/0000-0001-9011-5431)
- Mathilde Marchand (ORCID: https://orcid.org/0000-0002-9130-9980)
- Jin Y. Jin (ORCID: https://orcid.org/0000-0002-3627-0323)
- René Bruno (ORCID: https://orcid.org/0000-0003-0200-039X)
- Chunze Li (ORCID: https://orcid.org/0000-0002-8906-6553)
- Kenta J. Yoshida (ORCID: https://orcid.org/0000-0003-4967-3831)
Institutions
- Genoway (France) (FR)
- Kaiser Permanente South San Francisco Medical Center (US)
- Délégation Provence et Corse (FR)
- International Drug Development (FR)
Publication Details
- Journal
- CPT Pharmacometrics & Systems Pharmacology
- Published
- 2026-07-30
- DOI
- https://doi.org/10.1002/psp4.70304
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00