Title: Design and analysis of adaptive clinical trials
Authors: Christopher Jennison - University of Bath (United Kingdom) [presenting]
Abstract: Clinical trials are conducted at various stages of the drug development process. The aims at each stage are different: Phase I trials are designed to find the maximum tolerated dose, possibly studying an efficacy response as well; Phase II trials seek the most effective dose and evidence that, at this dose, the new treatment will be superior to the control; at the confirmatory stage, Phase III trials are conducted to demonstrate the superiority of the new treatment with respect to the primary endpoint. In order to create an efficient design for a given trial, the goal of that trial needs to be specified and this requires a clear view of the role of the trial in the wider process. We shall present examples of such model-based decision making and the development of efficient experimental designs for: dose escalation in a Phase I trial; the transition from Phase II to Phase III trials; adaptive enrichment in a Phase III trial.