A flexible design for advanced Phase I/II clinical trials with continuous efficacy endpoints.

ABSTRACT: There is growing interest in integrated Phase I/II oncology clinical trials involving molecularly targeted agents (MTA). One of the main challenges of these trials are nontrivial dose-efficacy relationships and administration of MTAs in combination with other agents. While some designs were recently proposed for such Phase I/II trials, the majority of them consider the case of binary toxicity and efficacy endpoints only. At the same time, a continuous efficacy endpoint can carry more information about the agent's mechanism of action, but corresponding designs have received very limited attention in the literature. In this work, an extension of a recently developed information-theoretic design for the case of a continuous efficacy endpoint is proposed. The design transforms the continuous o

SUBMITTER: Mozgunov P 

PROVIDER: S-EPMC6899762 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature