Phase1RMD: An R package for repeated measures dose-finding designs with novel toxicity and efficacy endpoints.

ABSTRACT: Traditional dose-finding designs are substantially inefficient for targeted agents and cancer immunotherapies by failing to incorporate efficacy signals, mild and moderate adverse events, and late, cumulative toxicities. However, the lack of user-friendly software is a barrier to the practical use of the novel phase I designs, despite their demonstrated superiority of traditional 3+3 designs. To overcome these barriers, we present an R package, phase1RMD, which provides a comprehensive implementation of novel designs with repeated toxicity measures and early efficacy. A novel phase I repeated measures design that used a continuous toxicity score from multiple treatment cycles was implemented. Furthermore, in studies where preliminary efficacy is evaluated, an adaptive, multi-stage design t

SUBMITTER: Yin J 

PROVIDER: S-EPMC8412295 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature