Metrics for Comparison of Phase I Dose-Finding Designs

• Activity Number: 549
• Type: Contributed
• Date/Time: Wednesday, August 12, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Hong Wang*
• Companies: University of Pittsburgh Cancer Institute
• Keywords: Phase I design ; maximum tolerated dose ; performance metrics

Abstract

For many phase I designs, the goal is to determine the maximum tolerated dose (MTD) which is the highest dose of a radiological or pharmacological treatment that will produce the desired efficacy without unacceptable toxicity. We give an overview of rule-based and model-based dose-finding designs. Metrics used in published papers for comparison of designs are summarized and discussed. A large simulation study is performed, using the selected metrics to compare several commonly used designs, including the 3+3, Narayana, continual reassessment method (CRM), Storer's, modified toxicity probability interval (mTPI), and toxicity equivalence range (TEQR) designs.