Leveraging Longitudinal Data in Dose-Finding Studies

• Activity Number: 326
• Type: Invited
• Date/Time: Tuesday, August 6, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Chyi-Hung Hsu*+ and Jose Carlos Pinheiro
• Companies: Janssen Research & Development and Janssen R&D
• Keywords: clinical trials ; dose finding ; longitudinal data analysis

Abstract

Incorrect dose selection for confirmatory studies remains one of the key drivers of the high attrition rate observed in late phase drug development. Even though this is a well-known problem in clinical drug development, sponsors are often reluctant to make larger investments in exploratory dose ranging studies, opting, instead, to save resources for costly Phase 3 studies. A possible remedy, or palliative, for this conundrum is the better utilization of clinical data already collected in Phase 2 studies, such as longitudinal measurements on clinical endpoints and biomarkers. This talk will focus on the use of dose-time response models incorporating all available clinical data to improve the efficiency and accuracy and dose selection. A real-data example will used to illustrate the challenges and benefits of the approach.