Experience with Using Simulation Models to Plan for Drug Supply in Adaptive Trials

• Activity Number: 663
• Type: Topic Contributed
• Date/Time: Thursday, August 5, 2010 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Nitin R. Patel*+ and Suvajit Samanta and Pralay Senchaudhuri and Christine Stocklin
• Companies: Cytel Inc. and Merck Research Laboratories and Cytel Inc. and Merck & Co., Inc.
• Keywords: adaptive trials ; simulation ; drug supply ; clinical trials ; multicenter trials

Abstract

Since the number of subjects on each treatment arm is not known at the start of an adaptive trial, planning drug supply for an adaptive trial is complex. Simple rules as used for traditional trials can result in very large wastage. A simulation approach that models the adaptive design, the site enrollment process, and the drug supply chain enables realistic estimation of the optimal supply of drug needed to control risk of randomization failure.

We describe experience with using this approach to plan drug supply for a variety of multicenter adaptive trials at Merck & Co. The simulations were run using the core modeling functions provided by the software package, CytelDSim. We describe these functions using an illustrative adaptive Bayesian dose ranging trial. The core software was customized for the Merck trials. We present details of the simulation results.