Tumor growth and overall survival modeling to support decision making in phase Ib/II trials: A comparison of the joint and two-stage approaches.
Autor: | Marchand M; Certara Strategic Consulting, Paris, France., Gonçalves A; Certara Strategic Consulting, Paris, France., Mercier F; Clinical Pharmacology, Genentech-Roche, Basel, Switzerland., Chanu P; Clinical Pharmacology, Genentech-Roche, Lyon, France., Jin JY; Clinical Pharmacology, Genentech, South San Francisco, California, USA., Guedj J; IAME, Université Paris Cité, Paris, France., Bruno R; Clinical Pharmacology, Genentech-Roche, Marseille, France. |
---|---|
Jazyk: | angličtina |
Zdroj: | CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 Jun; Vol. 13 (6), pp. 1017-1028. Date of Electronic Publication: 2024 Apr 17. |
DOI: | 10.1002/psp4.13137 |
Abstrakt: | Model-based tumor growth inhibition (TGI) metrics are increasingly used to predict overall survival (OS) data in Phase III immunotherapy clinical trials. However, there is still a lack of understanding regarding the differences between two-stage or joint modeling methods to leverage Phase I/II trial data and help early decision-making. A recent study showed that TGI metrics such as the tumor growth rate constant K (© 2024 Genentech, Inc. Institut Roche and F. Hoffmann‐La Roche AG. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.) |
Databáze: | MEDLINE |
Externí odkaz: | |
Nepřihlášeným uživatelům se plný text nezobrazuje | K zobrazení výsledku je třeba se přihlásit. |