Modified isotonic regression based phase I/II clinical trial design identifying optimal biological dose.

ABSTRACT: Conventional phase I/II clinical trial designs often use complicated parametric models to characterize the dose-response relationships and conduct the trials. However, the parametric models are hard to justify in practice, and the misspecification of parametric models can lead to substantially undesirable performances in phase I/II trials. Moreover, it is difficult for the physicians conducting phase I/II trials to clinically interpret the parameters of these complicated models, and such significant learning costs impede the translation of novel statistical designs into practical trial implementation. To solve these issues, we propose a transparent and efficient phase I/II clinical trial design, referred to as the modified isotonic regression-based design (mISO), to identify the optimal bi

SUBMITTER: Qiu Y 

PROVIDER: S-EPMC10065963 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature