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In the Interim...

Berry
Clinical Trials
Bayesian Statistics
Adaptive Trials
I-Spy 2
FDA
Alpha
Endovascular Therapy
Platform Trials
Trastuzumab
Pertuzumab
Adaptive Clinical Trials
Drug Development
Regression To the Mean
Interim Analyses
Adaptive Designs
Breast Cancer
Her2-Positive Breast Cancer
STEP Platform Trial
Acute Stroke
Adaptive Trial Design

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 tailore... more

PublishesWeeklyEpisodes53Foundeda year ago
Number of ListenersCategories
Health & FitnessScienceMedicineMathematics

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Latest Episodes

In this episode of "In the Interim…", Dr. Scott Berry interviews Professors Steven Tong and Josh Davis about the SNAP platform trial for Staphylococcus aureus bacteremia. The discussion covers SNAP’s rationale, large-scale adaptive design, methodolog... more

In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele examine Bayesian borrowing in Phase 3 clinical trials, focusing on statistical handling of prior information and real-world FDA interactions. The episode opens with an analogy, ... more

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In Episode 51 of "In the Interim…", Dr. Scott Berry interviews writer, producer, and performer Shaun Cassidy to examine the practical elements of storytelling that matter in scientific and statistical communication. Cassidy draws on his experience in... more

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In this episode of "In the Interim…", Dr. Scott Berry and Dr. Lindsay Berry investigate the statistical foundations and clinical implications of analyzing ordinal endpoints, drawing on experience from major stroke and COVID-19 trials. Discussion cent... more

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Recent Guests

Shaun Cassidy
Singer, actor, writer-producer; creator of TV shows including The Hardy Boys and American Gothic
Self/Various TV projects
Episode: The Art of Storytelling with Shaun Cassidy
Lindsay Berry
Statistician focused on Bayesian methods and clinical trial design
Berry Consultants
Episode: The Fallacy of Ordinal Endpoints
Nathan O'Hara
Associate professor of orthopedics at the University of Maryland School of Medicine and principal epidemiologist for the MAPT trial.
University of Maryland School of Medicine
Episode: Platform Trial in Orthopaedic Surgery
Gerard Slobogean
Professor of orthopedics and director of the Biomedical and Translational Science Master's program at the University of California, Irvine.
University of California, Irvine
Episode: Platform Trial in Orthopaedic Surgery
Sheila Sprague
Associate professor in the Department of Surgery and research director of the Surgical Methods Center at McMaster University.
McMaster University
Episode: Platform Trial in Orthopaedic Surgery
Michael Harhay
Associate Professor of Epidemiology, Medicine, and Statistics and Data Sciences; founding director of the Center for Clinical Trials Innovation
University of Pennsylvania
Episode: A Visit with Michael Harhay
Dr. Jenny Devenport
Global Head of Methods, Collaboration and Outreach at Roche
Roche
Episode: Communication for Scientists: A Discussion with Jenny Devenport
Kaspar Rufibach
Co-heading a group in Advanced Biostatistical Sciences at Merck.
Merck
Episode: Discussion with Kaspar Rufibach
Jeff Saver
Carolyn James Collins Distinguished Professor of Neurology at UCLA and Director of the UCLA Comprehensive Stroke and Vascular Neurology Program.
UCLA
Episode: A Visit with Stroke Neurologist Dr. Jeff Saver

Host

Scott Berry
Host and key figure in discussions focusing on statistical science and clinical trials, particularly Bayesian statistics and adaptive methodologies.

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Talking Points

Recent interactions between the hosts and their guests.

The Fallacy of Ordinal Endpoints
Q: How has this discussion evolved with Remap-CAP and other platform trials?
In Remap-CAP, the endpoint includes death and organ support days, and while proportional odds can be appealing, clinicians criticized the imposed weights from the model. This prompted exploration of more clinically informed weighting and ongoing work to publish a framework for deriving weights from patient-centered data.
The Fallacy of Ordinal Endpoints
Q: What is the core argument against a purely proportional odds approach?
The main concern is that proportional odds hides the actual clinical utilities behind weights that are implicit in the data (prevalence). Our critique is that you can and should quantify the weights from utilities or quality-of-life data rather than assume a single, abstract proportional shift.
Bayesian Statistics in Clinical trials: The Past, Present, and Future
Q: Are there ethical concerns in giving a patient treatment with a prior probability that's lower than a different treatment?
Yes, and the clinical trial community tries to maintain treatment equalities by randomizing trials, which can obscure ethical considerations.
Bayesian Statistics in Clinical trials: The Past, Present, and Future
Q: So, Scott, leading into around the year 2000, when you and Don founded Berry, where was your head at with the I-Spy 2 trial?
At that time, there was uncertainty regarding the utility of Bayesian clinical trials, but over the years, they have proven effective despite initial challenges.
Teaching Statistics and Data Science through Sports with Dr. Jim Albert
Q: What skill set should someone interested in sports statistics focus on as an undergraduate?
They need a background in statistics and modeling, some experience in the sport, and the ability to communicate their work effectively.

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What is In the Interim... about and what kind of topics does it cover?

A distinctive exploration of statistical science and clinical trials is featured, focusing particularly on Bayesian statistics and adaptive trial designs. Numerous episodes provide insights into innovative methodologies that transcend traditional boundaries, emphasizing data-driven strategies aimed at improving trial outcomes while ensuring both efficacy and safety. Engaging discussions often involve industry experts sharing their experiences and expertise, making complex medical and regulatory topics accessible and relatable for listeners. Alongside a commitment to addressing pressing medical challenges, the content fosters a provocative dialogue on evolving practices in clinical research, thus motivating professionals in the pharmaceutica... more

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2. The Bulwark Podcast
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In the Interim... launched a year ago and published 53 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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Recent guests on In the Interim... include:

1. Shaun Cassidy
2. Lindsay Berry
3. Nathan O'Hara
4. Gerard Slobogean
5. Sheila Sprague
6. Michael Harhay
7. Dr. Jenny Devenport
8. Kaspar Rufibach

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