Risk-benefit trade-offs and precision utilities in phase I-II clinical trials

CONCLUSIONS: Herein, we first describe why it is essential to consider clinical practice when designing a clinical trial and outline a stepwise process for doing this. We then review a precision phase I-II design based on utilities tailored to prognostic subgroups that characterize efficacy-toxicity risk-benefit trade-offs. The design chooses each patient's dose to optimize their expected utility and allows patients in different prognostic subgroups to have different optimal doses. We illustrate the design with a dose-finding trial of a new therapeutic agent for metastatic clear cell renal cell carcinoma.PMID:38111231 | DOI:10.1177/17407745231214750
Source: Clinical Trials - Category: Research Authors: Source Type: research