In Episode 11 of "In the Interim…", we discuss the nuances of implementing adaptive clinical trials with Dr. Anna McGlothlin and Dr. Michelle Detry from Berry Consultants. Both Anna and Michelle, seasoned Directors and Senior Statistical Scientists, shed light on the critical role their team plays in innovative adaptive clinical trials. They describe the frequent challenges and highlight the importance of high-quality trial implementation to ensure accurate and reliable outcomes, making this episode a must-listen for anyone involved in clinical trials.

Key Highlights:

• Insight into the statistical implementation of adaptive clinical trials.
• Logistics of data handling, to running the statistical model, to interactions with Data and Safety Monitoring Boards (DSMBs).
• Preparatory steps required before an adaptive analysis, ensuring the pre-specified design is adhered to and carried out as planned.
• The importance of understanding data in real-time and dealing with interim data idiosyncrasies.

Quotes:

• "We want the adaptive part of the trial to be invisible to sites—analyses might happen in the background without interference." – Scott Berry
• "Our goal is five business days from when we receive the data to when we send the result to the DSMB." – Michelle Detry
• "We always want to make sure that we have time, not just to hit a button and run an analysis and spit out a table, but to think and make sure that the results we’re producing make sense." – Anna McGlothlin