Podcast · Tech & Science

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 w

New episodes: Weekly
Typical length: 47 min
Latest: 12 Oct 2026
Language: English

Latest episode

12 Oct 2026 · 47 minNew

A Discussion on Virtual Controls

In this episode of "In the Interim…", Dr. Scott Berry shares the framework he presented at a CSRC regulatory science hackathon on digital twins and synthetic controls in cardiovascular clinical trials. He separates three kinds of models that are often given the same name: population-level statistical models (a historical control rate), patient-level statistical models (propensity matching, Cox models, hot-deck imputation, and black-box machine learning predictions), and system-level digital twins of human biology. Drawing on ARPA-H's CIRCLE program for ICU immune modulation, the Framingham…

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Earlier episodes 29 most recent

E80 · 28 Sep 2026 · 43 min
Clinical Trial Arenas: Direct Communication to Patients
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 two-year construction project dismantled the moment the contest ends. The episode distinguishes platform…
E79 · 21 Sep 2026 · 45 min
Science Coaching With Alun Bedding
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 on advice, mentoring, or therapy. Alun and Scott draw a direct line between good coaching and good…
E78 · 14 Sep 2026 · 46 min
The CHIPS Trial: Bayesian Adaptive Trial in JAMA
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 Bayesian adaptive design was used to find the maximum safe cold-storage duration rather than testing a single…
E77 · 7 Sep 2026 · 39 min
NFL Study of CTE: The Issues
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). After flagging multiplicity and small-sample issues in the first two studies, Scott spends most of the…
E76 · 31 Aug 2026 · 47 min
Talkin' 'bout Sweet Time
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 of acronyms such as MCID, CSD, and Target Product Profile (TPP). Dr. Berry advises trialists to resist…
E75 · 17 Aug 2026 · 1 hr 6 min
Mammograms: Death Threats, Hillary Clinton and Lead-Time Bias
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 40s is modest (an estimated 1.4-day average life extension and 18% hazard reduction). The panel…
E74 · 10 Aug 2026 · 52 min
REMAP-CAP Results: Oseltamivir in Critically-Ill Influenza Patients
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 analyses showed greater harm in patients with higher illness severity. Sensitivity analyses using…
E73 · 5 Aug 2026 · 55 min
ICECAP: The Results
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 School of Medicine), and Dr. Sharon Yeatts (Professor of Biostatistics, Public Health Sciences, Medical…
E72 · 3 Aug 2026 · 40 min
Failure of the Proportional Odds is the Result
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 heterogeneity and react by creating analysis methods that obscure the clinical relevance of a violation…
E71 · 27 Jul 2026 · 31 min
Adaptive Design Actions Matrix
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 examined include group sequential designs, “promising zone” sample size re-estimation (citing the formal…
E70 · 20 Jul 2026 · 44 min
A Visit With Tim Berry
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 Collins, where analytics had limited organizational impact, before joining Merkle and transforming…
E69 · 13 Jul 2026 · 35 min
Fairness in Soccer and Clinical Trials
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 procedures in science. He references how systems thrive, or fail, on clear, consistently applied standards.…
E68 · 6 Jul 2026 · 39 min
Bias in Stopping Trials Early
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 the error of restricting bias estimates to only successful (early-stopped) trials. The hosts present a…
E67 · 22 Jun 2026 · 46 min
A Statistician Reads JAMA: A Futile Issue
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 predictive probability calculation that produced a much lower and more realistic estimate of success. In…
E66 · 15 Jun 2026 · 47 min
Response-Adaptive Randomization in Clinical Trials
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 patient assignments during interim analyses to direct more patients to better-performing arms, but this…
E65 · 8 Jun 2026 · 53 min
REMAP-CAP: The Origin
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 subsequent federation across Australia and Canada. The discussion details REMAP-CAP’s technical…
E64 · 1 Jun 2026 · 56 min
Fighting Time in Adaptive Trials
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 discussion prioritizes a critical, empirical perspective of demonstrating how carefully constructed…
E63 · 25 May 2026 · 51 min
ICECAP: The Adaptive Design
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 methodological strategies: a weighted mRS primary endpoint, Bayesian adaptive trial structure,…
E62 · 18 May 2026 · 33 min
Multi-Platform RCT
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 analyses, and stratify patients by disease severity and D-dimer level. He examines the unified Bayesian…
E61 · 11 May 2026 · 51 min
Sports and Clinical Trials: The 1927 Yankees, 15 Tarzans, and Modern Athletes
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 comparisons between generations. He translates this approach directly into platform clinical trials,…
E60 · 4 May 2026 · 51 min
AI @ Berry
In the 60th episode of “In the Interim…”, Dr. Scott Berry, Dr. Nick Berry, and Dr. Joe Marion discuss how Berry Consultants uses AI in clinical trial design and software development. The conversation addresses current applications, limitations, implications for productivity, and the ongoing need for human expertise in clinical trial design. The team examines both promising use cases and the risks associated with security, compliance, and AI-generated statistical work. Key Highlights AI is used to develop user interfaces and code modules, notably expediting tasks like R Shiny app development…
E59 · 27 Apr 2026 · 52 min
Drug Development and Sports: The 10-Run Rule and Futility
In this episode of "In the Interim…", Dr. Scott Berry and Dr. Nick Berry investigate how futility in clinical trials and stopping rules in sports illuminate very similar decision problems, albeit with very different consequences. Drawing from baseball’s 10-run rule, tournament cuts in golf, the discussion confronts traditional and Bayesian strategies for interim decisions. The episode explains why simulation, not historical trial review, provides the empirical backbone for futility boundaries in clinical trials, and details the mechanics and consequences of aggressive stopping criteria.…
E58 · 20 Apr 2026 · 41 min
ICH-E20, Regulators, and False Choices
In this episode of "In the Interim…", host Dr. Scott Berry undertakes a detailed, methodical critique of ICH-E20 draft guidance language as applied to adaptive clinical trial design. Focusing on an innocuous but corruptible paragraph in Section 3.1, Scott scrutinizes the logic behind regulatory reluctance to appreciate multiple or complex adaptations in confirmatory trials. Drawing on extensive experience, he highlights how such restrictive interpretations do not reflect practical development realities, instead setting up “false choices” where alternative designs desired by regulators are…
E57 · 13 Apr 2026 · 53 min
PANTHER: A Phase 2 International Platform Trial in ARDS
In this episode of "In the Interim…" Dr. Scott Berry is joined by Professors Victoria Cornelius, Danny McAuley, and Anthony Gordon, for a technical review of the PANTHER trial—an international, Phase 2 adaptive platform evaluating pharmacologic interventions for ARDS. The trial is open-label and does not employ blinding, as discussed in the episode. The primary endpoint is 28-day organ support-free days (death as -1, survivors 0–28 days), analyzed with a Bayesian proportional odds model. PANTHER uses stratification by hyper- and hypoinflammatory subphenotypes, with fixed, equal randomization…
E56 · 6 Apr 2026 · 40 min
A Visit with Byron Gajewski: KUMC, Innovative Trial Designs, the HOBIT Trial
In this episode of "In the Interim…", Dr. Scott Berry connects with Dr. Byron Gajewski, professor of biostatistics and data science at the University of Kansas Medical Center (KUMC), for a detailed discussion on the design, simulation, and operational realities of Bayesian adaptive clinical trials in academic environments. Gajewski discusses his academic background, training at Texas A&M, and progressive adoption of Bayesian principles based on direct experiential advantages in complex data settings. The conversation highlights KUMC’s Fixed and Adaptive Clinical Trial Simulator Working…
E55 · 30 Mar 2026 · 47 min
A Visit with Stephen Senn: Time, Concurrent Controls, and the Bayesian Guidance
In this episode of "In the Interim...", Dr. Scott Berry hosts Dr. Stephen Senn, award-winning statistician and author, for a discussion on advanced challenges in adaptive and platform trial methodology. Senn draws on experience in academic, pharmaceutical, and regulatory settings to address the recent draft guidance on Bayesian statistics from the FDA and multiple controversies in clinical trial design. Key Highlights Emphasizes understanding data origin and regression to the mean as essential for trial interpretation, above adherence to Bayesian or frequentist frameworks. Details…
E54 · 23 Mar 2026 · 54 min
Making Sense of Hierarchical Composites
In this episode of "In the Interim…", Dr. Scott Berry is joined by statisticians Dr. Amy Crawford, Dr. Cora Allen-Savietta, and Dr. Jessica Overbey for a technical deep dive into hierarchical composite endpoints and the win ratio in clinical trial design. The group addresses clinical and statistical justifications for layered endpoint structures, demonstrates the mechanics of pairwise win ratio analysis, and explores operational and interpretive consequences in both conventional and adaptive trials. The panel scrutinizes analytic limitations, regulatory concerns, and emerging modeling…
E53 · 16 Mar 2026 · 54 min
The SNAP Trial with Professors Tong and Davis
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, methodology, and operational execution at approximately 150 hospitals in 13 countries. Key statistical questions, domain results, pediatric-adult analysis, and global implementation strategy are explored in depth. Listeners will find clear examples of how adaptive platform trials can efficiently address clinically relevant questions in infectious disease,…
E52 · 9 Mar 2026 · 47 min
Bayesian Borrowing in Phase 3 Trials
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, comparing prior probability in Bayesian analysis to interpreting a home pregnancy test, succinctly demonstrating the effect of prior knowledge on trial interpretation. The discussion addresses technical challenges—how borrowing inflates Type I errors and why this is addressed differently under Bayesian operating characteristics. Concrete examples…

About In the Interim...

In the Interim... is a English tech & science podcast from Berry. Melo plays each episode straight from the publisher's own feed — no ads added, no account needed — and remembers where you stopped, in this browser only.

Publisher: Berry
Language: English
Category: Tech & Science
New episodes: Weekly
Typical length: 47 min
Latest episode: 12 Oct 2026
Feed: RSS — paste into any podcast app
Apple Podcasts: podcasts.apple.com/podcast/id1796598706

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