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
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41:25
Revisiting Seamless 2/3 Trial for GLP-1 Agonist
In this episode of "In the Interim..." we revisit the ground-breaking seamless phase 2/3 clinical trial for the GLP-1 agonist, dulaglutide—better known as Trulicity. We discuss the intricacies of the adaptive trial design, and the unique features that helped expedite development by 12-18 months. Listeners will gain insight into how Bayesian algorithms and innovative statistical methods were pivotal in navigating a complex trial design, benefiting Eli Lilly's pipeline and changing the landscape of diabetes treatment.Key Highlights:Outline of the trial design and the barriers faced during its inception in 2007-2008.Explanation of the Clinical Utility Index and its role in adaptive randomization.The DSMB's role and interaction with Bayesian decision-making models.Simulation-based design to optimize development efficiencies.Insights into the predictive power of the trial on weight loss outcomes in subsequent trials.Quotes:"The trial was run entirely by Bayesian algorithms." – Scott Berry"They believed this utility function was absolutely the right way to go forward." – Scott Berry
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42:37
I-SPY 2 to GBM AGILE and Beyond
In this episode of "In the Interim...," we sit down with Dr. Meredith Buxton to explore the evolution of platform trials from I-SPY 2 to GBM AGILE and Beyond. With a rich history in innovative trial design, Meredith shares the journey from pioneering adaptive clinical trials in breast cancer with I-SPY 2 to her current role at the Global Coalition for Adaptive Research (GCAR). This conversation offers insights into accelerating clinical trial timelines, innovative operational frameworks, and their applications across multiple medical domains, making it a must-listen for anyone involved in clinical development and platform trials.Key Highlights:• Meredith Buxton discusses the origins and groundbreaking operations of the I-SPY platform in breast cancer.• Exploration of how the I-SPY 2 model inspired subsequent platform trials in diverse areas such as glioblastoma and COVID-19.• GCAR's role as a non-profit entity to foster adaptive trial designs and Meredith’s influential contributions to its formation and success.• Discover the operational complexities and regulatory considerations essential for modern platform trials.• Insights into Meredith’s vision for the future of drug development and the ongoing necessity for innovation in trial design.Quotes:• “The ideas of this are groundbreaking in many ways.” – Scott Berry• "The I-SPY2 model could be replicated in other spaces." – Meredith Buxton
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33:26
External Data in Clinical Trials
In this episode of "In the Interim...," Scott Berry and Kert Viele navigate the nuanced debate surrounding the integration of external data in clinical trials. Discover the implications and potential benefits and pitfalls of leveraging historical and real-world evidence in the analysis of clinical trials. Key Highlights:• Exploration of how external data can influence clinical trial analyses and the inherent risks versus rewards.• Examination of the frequentist versus Bayesian perspectives on data integration.• Discussion of real-world cases where external data has been used.• Debate on the conservative nature of current scientific approaches and how they may hinder progress.• Insight into the future of clinical trials harnessing external data – a step towards better medical science.Quotes:"If prior data isn't generally leading us in the right direction, we ought to reconsider the basis of scientific inquiry." – Kert Viele"The industry's hesitance to use existing data slows innovation and limits our ability to bring effective treatments to market." – Scott Berry
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28:35
Remembering Jimmie Savage
In this episode of "In the Interim," Don Berry shares the life and work of Jimmie Savage, his advisor and a legendary figure in Bayesian statistics. Hosted by Scott Berry, the discussion reveals the personal and professional experiences that shaped Savage's groundbreaking contributions. Discover the intricacies of Savage's influence on statistical thought and his profound legacy, from his tragic childhood to a profound effect on Bayesian statistics and scientific thought.Key Highlights:• Don Berry shares the personal story of Jimmie Savage's troubled childhood and how it influenced his work and personality.• Insights into Savage's pioneering role as the father of modern Bayesian statistics.• Discussion on Savage's varied interests and collaborations with figures like Milton Friedman and John von Neumann.• Don Berry recounts his academic experiences alongside Savage and his own journey into clinical trial design.• Exploration of Savage's legacy through his students and his axiomatic approach to subjective probability.Quotes:• "I think he's the father of modern Bayesian statistics. How can you argue about that?" – Don Berry• "The world around you when you're with Savage is tingling with intellect." – Don Berry• " We probably wouldn't exist... if it were not for him." – Don Berry
A podcast on statistical science and clinical trials.
Explore the intricacies of Bayesian statistics and adaptive clinical trials. Uncover methods that push beyond conventional paradigms, ushering in data-driven insights that enhance trial outcomes while ensuring safety and efficacy. Join us as we dive into complex medical challenges and regulatory landscapes, offering innovative solutions tailored for pharma pioneers. Featuring expertise from industry leaders, each episode is crafted to provide clarity, foster debate, and challenge mainstream perspectives, ensuring you remain at the forefront of clinical trial excellence.
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