The Role of Statisticians in Risk-Based Monitoring

• Activity Number: 217
• Type: Topic Contributed
• Date/Time: Monday, August 4, 2014 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): William Lawton*+
• Companies: Boehringer Ingelheim
• Keywords: Risk Based Monitoring ; QC statistics ; Clinical Trial

Abstract

Risk Based Monitoring (RBM) in Clinical Trials is the current buzz word throughout the industry, it is not about reduced onsite monitoring, its primary focus is improved quality. Quality of course, is a critical issue to all statisticians when we come to analysing the data, but RBM demands our attention from the earliest moment to ensure that quality is achieved. This presentation will outline the input required from statisticians to define what data needs to controlled, the acceptable level of variation and action limits. During the study conduct the statistician will be more involved is the mitigation of new risks in terms of identifying acceptal samples and error rates. These new topics bring the Pharmaceutical Industry and other Biostatisticians into the tradidional areas of QC statistics, more commnly associated with manufacturing processes.