Operational Bias in Adaptive Designs: Potential Sources and Mitigation Strategies

• 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): Michelle Detry*+
• Companies: Berry Consultants
• Keywords: adaptive clinical trials ; operational bias ; mitigation strategies

Abstract

Operational bias results when information from an ongoing clinical trial causes changes to the participant pool, investigator behavior or other clinical aspects that affect the conduct of the trial in such a way that conclusions about important efficacy or safety parameters are biased. The possibility of operational bias is unavoidable during an adaptive clinical trial. Potential sources of operational bias should be identified and the consequences considered and addressed to the extent possible. Mitigation of operational bias often requires controlling leakage of information. Thus, when designing adaptive trials, the implementation of the design should be considered as well as the statistical details. I will present strategies for implementation of adaptive designs with a focus on minimizing operational bias.