In the Interim...

Dr. Scott Berry applies a statistician’s review of a random trial result published in JAMA – the FAIR-HF2 clinical trial.  Interrogating the frequentist paradigm and the focus on the binary outcome of the primary hypothesis test. He scrutinizes the Hochberg multiplicity adjustment, challenges the prevailing disregard for accumulated scientific evidence, and contrasts the limitations of black/white...

Scott Berry convenes co-authors Kert Viele, Joe Marion, and Lindsay Berry to discuss the statistical and developmental nuances of inferentially seamless phase 2/3 clinical trial designs. The group dissects the simple method for distributing alpha when including stage 1 data, whether it is a good idea to distribute alpha, and the optimal allocation of sample size when Stage 1 data are carried forwa...

In this solo episode of "In the Interim...", Scott Berry, President and Senior Statistical Scientist at Berry Consultants, addresses deep-rooted confusion in the field of adaptive clinical trial design surrounding the concept of “spending alpha.” Drawing on practical experience and rigorous statistical foundations, Berry addresses the prevailing language and myths that conflate interim analysis wi...

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 conversa...

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 m...

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 specific...

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 : Ove...

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 impor...

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 pivota...

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 of...

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...

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 c...

In this compelling episode of "In the Interim," Dr. Mike Krams, a seasoned expert in clinical trials and drug development, joins us to discuss the art and slog of innovation in pharmaceutical companies. With over 30 years in the field, Dr. Krams shares insights on leveraging Bayesian statistics and innovative designs to transform development approaches. The conversation explores disruptive approac...

In this episode of "In the Interim," Dr. Scott Berry discusses the vital topic of ordinal outcomes in clinical trials—a subject as controversial as politics and religion at the dinner table. Using historical examples like James Lind's 1747 scurvy trial and Austin Bradford Hill’s pioneering randomized trial, the episode explores the complexities and ongoing debates about analyzing ordinal endpoints...

In this episode of the podcast, we sit down with Dr. Merit Cudkowicz and Dr. Melanie Quintana to discuss the inception and execution of the Healy ALS Platform Trial, a revolutionary approach designed for efficiency and impactful data collection. With insights from both medical and statistical perspectives, this episode offers a comprehensive understanding of the trial's structure and outcomes, she...

In this episode of "In the Interim," Berry's Director of Software, Tom Parke, takes us into the fascinating realm of clinical trial simulation. With Tom joining from the UK, we discuss the intricacies and updates surrounding FACTS, a sophisticated clinical trial simulation software. Learn about its significance in designing adaptive trial designs and its latest enhancements with the release of FAC...

In this episode of "In the Interim," we consider the nuances of adaptive design clinical trials with distinguished guests Dr. Scott Berry and Dr. Kert Viele from Berry Consultants . The conversation centers around the vital question: when should these adaptive designs be implemented? Listeners will gain invaluable insights into the mechanics of adaptive trials, the Bayesian approach, and scenarios...

In the inaugural episode of Berry's "In the Interim...," we sit down with the founders of Berry Consultants, Dr. Don Berry and Dr. Scott Berry. Celebrating their 25th anniversary as a company, they explore the pioneering journey of their firm, known for transforming the landscape of clinical trials with their adaptive and Bayesian methodologies. With stories from their early days to innovative pro...