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Activity Number: 372
Type: Contributed
Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #316356
Title: Retrospective Meta-Analyses for Phase I Studies
Author(s): Sarah Zohar* and Anand Vidyashankar and Jie Xu
Companies: INSERM UMR 1138 and George Mason University and George Mason University
Keywords: phase I ; dose-finding ; meta-analysis ; maximum tolerated dose

Estimating the maximum tolerated dose (MTD) is one of the critical aspects of Phase I analyses. However, in practice due due to small sample size if Phase I studies, the estimates of MTD are highly unreliable due to excessive variability between trials. In this presentation we describe three methods to combine information between trials to obtained a pooled estimate of MTD. The methods are based on (i) averaging (ii) random effect modeling and (iii) weighted averaging. We provide precise conditions when each of these methods are applicable in real practice. Additionally, we also provide a new methodology to construct confidence intervals for the pooled MTD. We provide a theoretical justification of our methodology and illustrate our results using several examples.

Authors who are presenting talks have a * after their name.

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