Interim Pharmacokinetic Assessment Using a Bayesian Decision Analysis in Phase II Clinical Trials

• Activity Number: 619
• Type: Contributed
• Date/Time: Thursday, August 2, 2012 : 8:30 AM to 10:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Bo Jin*+ and Keying Ye
• Companies: Pfizer Inc. and The University of Texas at San Antonio
• Keywords: Dose Finding ; Bayesian Decision ; Interim Analysis

Abstract

Dose-finding clinical trials are to study several appropriate doses and regimen, so that the data collected later can sufficiently characterize the dose-response curve, from which an optimal dose can be selected into Phase III. The doses to investigate in a dose-finding study are usually determined based on previous knowledge on potential pharmacokinetic and pharmacodynamic profiles, including literature data for the compounds in the same class, preclinical data, pharmacokinetic and pharmacodynamic analyses from Phase I studies etc. On the other hand, there are uncertainties about the dose studied, e.g., the study population and drug formulation may be different from previous trials, and the predictions from previous trials may not be appropriate. In this presentation we introduce an interim pharmacokinetic assessment using a Bayesian decision analysis, which combines the data from previous studies and the data in the current study, to verify the underlying PK assumptions for the doses selected in the current study. The decision rules and the corresponding operational characteristics for such an interim assessment will be presented.