In this episode of "In the Interim…", host Dr. Scott Berry is true to the name of the podcast, as he discusses the unblinded world of adaptive clinical trials alongside Dr. Roger Lewis, a renowned expert in both statistical science and clinical medicine. Together, they explore the critical role of Data Safety Monitoring Boards (DSMBs) in safeguarding trial integrity and participant safety specifically for adaptive trials. The discussion navigates the complexities and challenges faced by DSMBs, particularly in adaptive trial contexts, offering valuable insights for anyone involved in clinical trial science.

Key Highlights
• Overview of the fundamental role and responsibilities of DSMBs in clinical trials.
• Discussion on how DSMBs ensure scientific integrity and participant safety in adaptive trials.
• Differences in DSMB involvement between traditional and adaptive trial designs.
• The evolving skillset required for DSMB members in the context of complex, adaptive trials.
• Exploration of the critical collaboration between DSMBs and Statistical Analysis Committees.

Quotes
• "The DSMB is tasked with balancing efficacy and safety at a very fundamental level." — Roger Lewis
• "Adaptive trials expand the role of the DSMB to ensure trials are conducted as intended." — Roger Lewis
• "The DSMB needs to review efficacy and safety to appropriately balance them." — Roger Lewis

In the latest episode of "In the Interim…", Dr. Scott Berry and Dr. Mike Krams sit down with Dr. Husseini Manji, to explore the potential of platform trials in advancing precision medicine within psychiatry. Listen as we discuss how an adaptive platform trial could transform drug development, paving the way for breakthroughs in understanding and treating psychiatric disorders.

Key Highlights:

• Overview of the burden of serious mental illness and the pressing need for innovative treatment approaches.
• Discussion on precision psychiatry and the potential of a platform trial to address the heterogeneity of psychiatric disorders.
• Insights into the advantages of biomarker-based adaptive trials in improving drug development success rates.
• Examination of potential sponsorship models for platform trials, emphasizing patient and industry collaboration.

Quotes:

• "Mental illnesses represent a significant global challenge with a staggering unmet need." – Husseini Manji
• "There's a real excitement about precision psychiatry—moving away from a one-size-fits-all approach." – Husseini Manji
• "The patient perspective is crucial for driving significant advances in psychiatric treatment." – Mike Krams
• "We believe that precision medicine biomarker-based adaptive trials could be game-changing in this space." – Husseini Manji

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