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Activity Number: 350 - Statistical Issues In Drug Development - 1
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #330962 Presentation
Title: Reversals in Early Phase Dose Finding Trials
Author(s): Bethany Horton* and John O'Quigley and Mark Conaway
Companies: University of Virginia and Universit'e Pierre et Marie Curie, and University of Virginia
Keywords: Dose-finding studies; Clinical trials; Phase I designs; Partially ordered groups

Implementation of parallel trials has been an accessible approach to early phase dose finding trials involving groups, where information is available on the differences in the risk of toxicity by group. Use of parallel trials often leads to dose recommendations that do not follow the known order of toxicity risk by group, or reversals in dose recommendation, such as recommending a higher dose level in a group of patients known to have a higher risk of toxicity. Several methods have recently become available which allow for incorporating varying amounts of group order information. While these methods eliminate the issue of reversals, simulation results indicate that they also improve operating characteristics, including increases in the frequency of selecting the best dose and treating a greater number of trial patients at the most appropriate dose.

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

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