Estimating Similarity of Dose-Response Relationships in Phase I Clinical Trials-Case Study in Bridging Data Package.

ABSTRACT: Bridging studies are designed to fill the gap between two populations in terms of clinical trial data, such as toxicity, efficacy, comorbidities and doses. According to ICH-E5 guidelines, clinical data can be extrapolated from one region to another if dose-reponse curves are similar between two populations. For instance, in Japan, Phase I clinical trials are often repeated due to this physiological/metabolic paradigm: the maximum tolerated dose (MTD) for Japanese patients is assumed to be lower than that for Caucasian patients, but not necessarily for all molecules. Therefore, proposing a statistical tool evaluating the similarity between two populations dose-response curves is of most interest. The aim of our work is to propose several indicators to evaluate the distance and the similarit

SUBMITTER: Ollier A 

PROVIDER: S-EPMC7916097 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature