BIPSE: A biomarker-based phase I/II design for immunotherapy trials with progression-free survival endpoint.

Guo, Beibei; Zang, Yong

Guo, Beibei; Zang, Yong.

Affiliation

Guo B; Department of Experimental Statistics, Louisiana State University, Baton Rouge, Louisiana, USA.
Zang Y; Department of Biostatistics and Health Data Science, Indiana University, Indianapolis, Indiana, USA.

Stat Med ; 41(7): 1205-1224, 2022 03 30.

Article in En | MEDLINE | ID: mdl-34821409

Subject(s)

Immunotherapy; Research Design; Bayes Theorem; Biomarkers; Computer Simulation; Dose-Response Relationship, Drug; Humans; Immunotherapy/adverse effects; Progression-Free Survival

Key words

Bayesian adaptive design; biomarker; dose finding; immune response; immunotherapy; phase I/II trial; progression-free survival; risk-benefit tradeoff; subgroups

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Full text: 1 Database: MEDLINE Main subject: Research Design / Immunotherapy Type of study: Clinical_trials / Prognostic_studies Limits: Humans Language: En Journal: Stat Med Year: 2022 Type: Article Affiliation country: United States

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