There is a growing number of Phase I dose-finding studies that use a model-based approach, such as the CRM or the EWOC method to estimate the dose-toxicity relationship. It is common to assume that all patients will have similar toxicity risk given the dose regardless of patients' individual characteristics. In many trials, however, some patients' covariates (e.
View Article and Find Full Text PDFInt J Environ Res Public Health
February 2021
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.
View Article and Find Full Text PDFStat Methods Med Res
August 2020
During drug evaluation trials, information from clinical trials previously conducted on another population, indications or schedules may be available. In these cases, it might be desirable to share information by efficiently using the available resources. In this work, we developed an adaptive power prior with a commensurability parameter for using historical or external information.
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