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PODCAST

In the Interim...

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

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All Episodes

43:02

Clinical Trial Arenas: Direct Communication to Patients

In the Interim... ·

2026/09/28

In this episode of "In the Interim…", Dr. Scott Berry recounts a presentation he gave to the Speak Foundation, a patient organization focused on limb-girdle muscular dystrophy and makes the case for master protocols directly to the stakeholder trials exist to serve. Opening with the deliberately absurd premise of a sports league that constructs a four-billion-dollar stadium for every single game and demolishes it at the final whistle, Scott reframes the conventional one-off trial as a

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45:11

Science Coaching With Alun Bedding

In the Interim... ·

2026/09/21

In this episode of "In the Interim…", Dr. Scott Berry talks with Dr. Alun Bedding, a professional certified coach and statistician who spent decades in pharmaceutical statistics, including as global head of statistical methods, collaboration, and outreach at Roche, before founding his own coaching and consulting practice. The conversation traces Alun's path from statistician to coach and unpacks what coaching is: a forward-facing partnership built on exploring a client's own thinking, not

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45:40

The CHIPS Trial: Bayesian Adaptive Trial in JAMA

In the Interim... ·

2026/09/14

In this episode of “In the Interim…,” Dr. Scott Berry talks with Dr. Roger Lewis, Dr. Anna McGlothlin, and Dr. Nick Berry — all co-authors on the CHIPS trial results recently published in JAMA (Spinella et al., August 2026) — about the design, implementation, and results. The conversation covers why room-temperature platelets, which can be stored only five to seven days, leave rural hospitals, low-volume centers, and military and disaster settings without a reliable supply, and how a

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38:46

NFL Study of CTE: The Issues

In the Interim... ·

2026/09/07

In this episode of "In the Interim…", Dr. Scott Berry examines three recent health-research headlines through a statistician's lens: an Adventist Health Study-2 analysis claiming eggs reduce Alzheimer's risk, an Emory University trial on high-dose vitamin D and cognition (Zhao et al.), and a British Medical Journal study led by Dr. Daniel Danishvar (Harvard, Boston University) reporting that 25 to 97 percent of deceased NFL players showed evidence of chronic traumatic encephalopathy (CTE)

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47:03

Talkin' 'bout Sweet Time

In the Interim... ·

2026/08/31

In this episode of "In the Interim...", Dr. Scott Berry dissects prevailing concepts of “clinically meaningful difference” in clinical trials focusing on progressive diseases. Through detailed examples from pancreatic cancer (Ben Sasse, Revolution Medicines), emphysema (Elevair), Alzheimer’s disease (lecanemab), and IVF, Scott challenges the adequacy of the population-mean of a continuous outcome in reflecting true patient benefit. The episode discusses inconsistent usage and interpretation

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65:42

Mammograms: Death Threats, Hillary Clinton and...

In the Interim... ·

2026/08/17

In this episode of "In the Interim…", Dr. Don Berry provides a detailed account of co-chairing the 1997 NIH consensus development conference on mammography for women in their 40s. His conversation with Dr. Scott Berry covers the statistical and clinical complexities of breast cancer screening, addressing lead time and length bias, trial design limitations. Don discusses the panel’s finding, based on randomized trials and meta-analysis, that the average benefit of screening women in their

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51:58

REMAP-CAP Results: Oseltamivir in Critically-Ill...

In the Interim... ·

2026/08/10

In this episode of "In the Interim…", Dr. Scott Berry speaks with Dr. Srinivas Murthy, Dr. Thomas Hills, and Dr. Lindsay Berry about the REMAP-CAP trial results on oseltamivir in critically ill influenza patients. The trial used a Bayesian covariate-adjusted platform design and found oseltamivir was not effective at reducing 90-day mortality with a “98% and 99% probability of harm in 90-day mortality” compared to control. Covariate adjustment addressed baseline and site variation. Subgroup

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54:42

ICECAP: The Results

In the Interim... ·

2026/08/05

In this episode of "In the Interim…", Dr. Scott Berry leads a comprehensive discussion of the ICECAP trial results with four Principal Investigators: Dr. Will Meurer (Professor, Emergency Medicine and Neurology, University of Michigan; consultant to Berry Consultants), Dr. Robert Silbergleit (Professor, Emergency Medicine, University of Michigan Medical School), Dr. Romer Geocadin (Professor, Neurology, Neurosurgery, and Anesthesiology and Critical Care Medicine, Johns Hopkins University

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40:20

Failure of the Proportional Odds is the Result

In the Interim... ·

2026/08/03

In this episode of "In the Interim…", Dr. Scott Berry and Dr. Elizabeth Lorenzi systematically examine the analytic pitfalls in recent acute ischemic stroke trials, especially the implications of violating the proportional odds assumption on the modified Rankin Scale. The discussion draws on the DISCOUNT, INSTANT, ESCAPE-MeVo, and ORIENTAL-MeVo trials, spotlighting frequent reactive shifts to proportional odds violations. Scott and Liz detail how such approaches obscure clinically relevant

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30:43

Adaptive Design Actions Matrix

In the Interim... ·

2026/07/27

In this episode of "In the Interim…", Dr. Scott Berry challenges the widely held belief that any interim look at trial data obligates an alpha adjustment. By constructing a two-by-two matrix: interim data (positive/negative) and adaptive action (increase/decrease sample size), Scott demonstrates that the need for statistical correction depends on precisely what actions are prespecified. He emphasizes that the need for adjustment depends on the action and the data. Technical scenarios

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44:20

A Visit With Tim Berry

In the Interim... ·

2026/07/20

In this episode of "In the Interim…," Dr. Scott Berry interviews Tim Berry, co-founder of Blend360, detailing a career that demonstrates the practical application of statistical and analytical methods within large-scale business environments. Tim outlines his quick shift from earning a master’s at the University of Minnesota to industry positions, starting at AT&T Bell Laboratories, where he built and tested retention models on millions of consumer records. He recounts his time at Rapp

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34:33

Fairness in Soccer and Clinical Trials

In the Interim... ·

2026/07/13

In this episode of "In the Interim...", Dr. Scott Berry investigates the practical meaning of fairness by connecting a controversial World Cup soccer ruling to foundational questions in clinical trial statistics. Scott scrutinizes FIFA’s unusual reversal of a red card suspension for US striker Folarin Balogun, referencing reports of US presidential influence, and draws explicit parallels between the enforcement of rules in international sport and the necessity for rigorously defined

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39:29

Bias in Stopping Trials Early

In the Interim... ·

2026/07/06

On the latest episode of "In the Interim...", Dr. Scott Berry and Dr. Kert Viele deliver a focused, technical analysis of statistical bias when stopping trials early. This episode clarifies the definition of bias, detailed within the context of interim analyses, emphasizing the empirical consequences of different stopping rules. The discussion addresses common misconceptions around interpretation as well as including the mathematical rationale for averaging across all trial outcomes, and

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46:13

A Statistician Reads JAMA: A Futile Issue

In the Interim... ·

2026/06/22

On the latest episode of "In the Interim…", Dr. Scott Berry provides an empirical examination of two recent JAMA trials: TRACK (low-dose rivaroxaban in advanced kidney disease) and VICTORY (IV vitamin C in severe burn injury). The TRACK trial lacked any pre-specified futility criteria, with a DSMB-initiated stop based on conditional power calculations. Scott argues that conditional power, especially in this interim context, is a poor, misleading tool—contrasting it against a Bayesian

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47:19

Response-Adaptive Randomization in Clinical Trials

In the Interim... ·

2026/06/15

In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele examine response-adaptive randomization (RAR) in clinical trials, dissecting its statistical rationale, common criticisms, and implementation challenges. Drawing on extensive experience with trials such as BAN2401 (lecanemab), ICECAP, dulaglutide seamless Phase 2/3, I-SPY2, REMAP-CAP, PROSPECT, and the historical ECMO trial, they discuss the scientific advantages and disadvantages and ethical impact. RAR reallocates

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53:29

REMAP-CAP: The Origin

In the Interim... ·

2026/06/08

In this episode of "In the Interim…", Dr. Scott Berry explores the origins of REMAP-CAP with Prof. Steve Webb, former chair of the REMAP-CAP International Trial Steering Committee. This episode examines how pandemic preparedness efforts after 2009 H1N1 shaped the design of an international, adaptive platform trial to be able to respond rapidly to new infectious threats. Steve and Scott explain the sequence of strategy meetings, the role of the PREPARE consortium in securing EU funding and

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56:09

Fighting Time in Adaptive Trials

In the Interim... ·

2026/06/01

In this episode of "In the Interim…", Dr. Scott Berry explores the challenge of protracted endpoint timelines in adaptive clinical trials and the statistical strategies used to increase the rate of actionable information gain. Drawing on detailed case studies from breast cancer (I-SPY 2), Alzheimer’s disease (BAN 2401), diabetes (AWARD-5/Trulicity), and cardiac arrest, Scott addresses the technical demands of longitudinal modeling and interim data imputation for accelerating learning. The

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51:23

ICECAP: The Adaptive Design

In the Interim... ·

2026/05/25

In this episode of "In the Interim…", Dr. Scott Berry is joined by Dr. Will Meurer, professor of Emergency Medicine and Neurology at the University of Michigan, for an in-depth discussion of the ICECAP trial’s adaptive Bayesian design. The discussion breaks down the scientific rationale for hypothermia after cardiac arrest, critiques legacy studies, and explores the justification for including both shockable and non-shockable rhythm types. The episode provides a detailed account of ICECAP’s

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32:40

Multi-Platform RCT

In the Interim... ·

2026/05/18

In this episode of "In the Interim…", Dr. Scott Berry details the design, execution, and results of the multi-platform randomized clinical trial (mpRCT) pioneered during the COVID-19 pandemic. He describes how REMAP-CAP, ATTACC, and ACTIV-4a—each developed independently—pooled data prospectively for joint analysis to address therapeutic anticoagulation in hospitalized COVID-19 patients. Scott outlines the operational rigor required to harmonize endpoints, establish monthly adaptive

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51:16

Sports and Clinical Trials: The 1927 Yankees, 15...

In the Interim... ·

2026/05/11

In this episode of "In the Interim…", Dr. Scott Berry examines the analytical challenges of comparing performance across eras in both sports and clinical research. Drawing from statistically robust family debates and published research, Scott details how overlapping competitors—such as athletes who played with both Babe Ruth, played with the next generation, who played with … all the way to playing with Aaron Judge—enable the estimation of temporal effects and allow for objective

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80 results

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