Scott Berry, Founder of Berry Consultants, interviews Professor Craig Ritchie—specialist in brain health and neurodegenerative diseases, Chief Investigator of EPAD (European Prevention of Alzheimer Dementia), and CEO of Scottish Brain Sciences—for a broad discussion of platform trial methodology in Alzheimer’s Disease research as well as looking towards the future of drug development. The conversation dissects the origins and ambitions of the EPAD initiative, the conception and scientific function of the readiness cohort, and the pragmatic obstacles to deploying innovative trial models within rigid institutional frameworks. Professor Ritchie details why the EPAD platform trial failed to initiate any therapies, explores the fallout and industry shifts following COVID-19, and maps how Scottish Brain Sciences is directly applying these lessons—establishing the IONA readiness cohort to drive integration between clinical research and clinical practice.

Key Highlights
• Systematic review of EPAD’s objectives, specifically the platform trial and the development of a readiness cohort to streamline patient recruitment
• Detailed account of practical barriers that prevented EPAD from launching interventional arms, including pharmaceutical sponsor reluctance, inflexible IMI funding mechanisms, and the inherent risk aversion surrounding novel platform structures
• Discussion of participant contribution to research design and delivery—an early demonstration of patient involvement models now broadly recognized as best practice
• Analysis of COVID-19's dual impact—derailing EPAD's momentum while catalyzing a change in industry and regulatory acceptance of platform trials in drug development
• Tracing the origins and operationalization of the IONA readiness cohort at Scottish Brain Sciences, including direct integration of recruitment, biobanking, and engagement systems to address the translational gap in dementia medicine
• Evidence-based critique of persistent use of conventional clinical trial formats in Alzheimer’s disease, dissecting operational, financial, and data limitations that stall progress

In this engaging episode of "In the Interim...", host Dr. Scott Berry is joined by Dr. Nick Berry to explore the intriguing statistical parallels between sports and drug development, focusing on the concept of "regression-to-the-mean." Presenting examples that seem clear in sports, they discuss how these insights can illuminate the challenges faced in clinical trials and scientific inferences in medical decision making. Whether you're a statistician, drug developer, or sports enthusiast, this episode offers valuable perspectives on data interpretation and statistical phenomena.

Key Highlights:
• Discussion on how lessons from sports can benefit drug developers, emphasizing the concept of regression-to-the-mean.
• Personal anecdotes from Scott and Nick's experiences, illustrating statistical learning through sports.
• Examination of the regression-to-the-mean phenomenon through examples from baseball and golf.
• Exploration of how misunderstanding the regression-to-the-mean can lead to poor decision-making in clinical trials.
• Insights into placebo effects and how they are often confused with natural statistical phenomena.
• How regression-to-the-mean impacts expectations in financial markets and personal finance decision-making.

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