Strategies to Mitigate Against Operational Bias in Adaptive Designs for Medical Device Trials

• Activity Number: 225
• Type: Topic Contributed
• Date/Time: Monday, August 4, 2014 : 2:00 PM to 3:50 PM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Caroline Morgan*+
• Companies: Cytel
• Keywords: adaptive design ; operational bias

Abstract

Adaptive designs are increasingly used in clinical trials. The Drug Information Association Adaptive Design Scientific Working Group (ADSWG) works to foster collaboration among regulatory agencies, academia, and pharmaceutical and biotech companies to further the science of adaptive clinical development. The results of an ADSWG survey on the perception and usage of adaptive designs in the industry and academia, as well as barriers to usage and recommendations to overcome these challenges, will be presented. Key barriers identified in the survey are related to time management: allowing adequate time for clinical trial simulation, discussions with the regulators, and operational planning to ensure that the appropriate firewalls are in place to minimize operational bias and preserve the integrity of the trial. Thorough preplanning to select and appropriately implement the most suitable trial design ultimately results in higher information value and increases the chance of trial success. This presentation will also consider ways to streamline workflow and mitigate operational bias based on practical experiences designing and implementing adaptive trials.