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In the Interim...: Daily Summaries Delivered
by 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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- 3 days ago44 min
Reflecting on EMA Reflections on Platform Trials
In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele, Director of Research at Berry Consultants, review the European Medicines Agency's draft reflection paper on methodological aspects in confirmatory platform trials. They walk through the paper's definition of a platform trial and explain why the shared control arm is the source of both the efficiency and the complexity of these designs. Scott and Kert discuss the paper's preference for constant allocation ratios between each arm and control, its position that response adaptive randomization is not supported, two-stage randomization with multiple placebos, and the strong preference given to concurrent controls. They make the case that non-concurrent controls, adjusted for time, are high-quality controls, and welcome the paper's view that they are preferable to external controls. The episode closes with the risk of multiple false positive decisions from a common control, disjunctive and conjunctive power, and when multiplicity adjustment is warranted, with overall praise for a clear and well-constructed paper.Key HighlightsThe shared control arm as the source of both efficiency and complexity in platform trials.Constant allocation ratios, and the paper's hard no on response adaptive randomization.Two-stage randomization, multiple placebos, and testing whether placebo groups can be pooled.A strong preference for concurrent controls, and the case for time-adjusted non-concurrent controls.Internal non-concurrent controls preferred over external controls.Multiple false positive decisions, and marginal, disjunctive, and conjunctive power.When multiplicity adjustment applies across arms, doses, and related families of hypotheses.For more, visit us at https://www.berryconsultants.com/
- 2 weeks ago55 min
Statistical Methodology Groups in the Pharmaceutical Industry
In this episode of "In the Interim…", Scott Berry is joined by Jenny Devenport and Kaspar Rufibach of Merck Group, co-authors of the EFSPI Statistical Methodology Leaders paper "Statistical Methodology Groups in the Pharmaceutical Industry," and May Mo of Amgen, a co-author of the commentary on the paper from the Statistical Innovation Community, an ASA Biopharmaceutical working group. The guests describe methodology groups within a pharmaceutical company as a strategic investment, and innovation as the product of invention and commercialization, where publication, regulatory dialogue, and validated software ("statistical engineering") turn new methods into common practice. They discuss why new mechanisms of action and therapies such as CAR-T need more than a t-test or a log-rank test, and how estimands, causal inference, adaptive designs, and external data borrowing are reaching clinical trial statistics. The conversation addresses the concern that a dedicated group divides methodologists from project statisticians, how these groups demonstrate their value, why quantitative decision-making is a core competence of a pharmaceutical company, and why curiosity and collaboration matter as much as technical skill.Key HighlightsInnovation as the product of invention and commercialization, and the role of methodology groups in scaling new methods.New mechanisms of action, from delayed immune activation to CAR-T, that a t-test or log-rank test cannot handle.Estimands, causal inference, adaptive designs, and external data borrowing entering clinical trial statistics.Avoiding a divide between methodologists and project statisticians, and why there is "no unicorn statistician."Showing value to leadership, from study involvement and due diligences to gains in probability of success.Quantitative decision-making: presenting design options with their risks, costs, and trade-offs.Curiosity, collaboration, and communication as the traits of an influential methodologist.For more, visit us at https://www.berryconsultants.com/
- 3 weeks ago47 min
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 risk model, the EMA-qualified use of AI-generated prognostic scores as covariates, and Novartis's recent Lp(a) outcomes trial, Scott examines what each type of model can and cannot replace in a trial. Dr. Berry argues that virtual controls should provide a full predictive distribution for each patient rather than a single forecast, and that Bayesian hierarchical models with prospectively enrolled controls allow a trial to verify those predictions as it runs. He closes with how much smaller trials could become, and why clinical trial science must adapt as natural history models improve.Key HighlightsReserving "digital twin" for system-level models of biology, not statistical predictions such as the Framingham risk model.ARPA-H's CIRCLE program: immune-system digital twins to guide ICU therapy, targeting a 25% reduction in ICU stay.Why a validated system-level digital twin would remove the need for a clinical trial.Prognostic scores as covariates versus virtual controls, and the counterfactual a control group is meant to supply.From a single historical control rate to patient-specific predictions built on patient-level data.Predictive distributions, not point forecasts, as the basis for comparing treated patients with virtual controls.Bayesian hierarchical models, MAP priors, and prospective controls to verify and calibrate virtual controls during the trial.For more, visit us at https://www.berryconsultants.com
- Sep 28, 202643 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 trials and basket trials as standing "arenas," explains the modular role of the master protocol described in Woodcock and LaVange's 2017 New England Journal of Medicine paper, and draws on worked examples including I-SPY 2, the HEALEY ALS Platform Trial, GBM AGILE, Precision Promise, and the ROAR basket trial. Scott takes each stakeholder in turn from the treatment arm sponsor, the site, the regulator, and the patient. Scott lays out how three-to-one randomization lets an arm fund 133 patients while reading out inferences with more than 200, how 667 patients in a single platform can do the work of 1,000 across five separate trials, and why far fewer patients are assigned to placebo. He closes on the genuine bottleneck: the first arena is the heavy lift, and in rare disease it is frequently patients themselves who make it happen.Key HighlightsThe one-game stadium analogy of two years to build a trial, one contest, then demolition.Platform trials and basket trials as standing arenas for multiple arms and multiple subtypes.Master protocols as modular documents, with arms plugging in and out as appendices.Worked examples from I-SPY 2, HEALEY ALS, GBM AGILE, Precision Promise, and the ROAR basket trial.A stakeholder-by-stakeholder view: arm sponsor, site, regulator, and patient.667 patients in one platform versus 1,000 across five separate trials, with far fewer on placebo.Bayesian borrowing across 39 limb-girdle subtypes, and the rare-disease shots never otherwise taken.For more, visit us at https://www.berryconsultants.com/
- Sep 21, 202645 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 statistical consulting as both begin by questioning the stated goal rather than accepting the first request at face value, whether that request is "I want to be a better manager" or "I need a power calculation." The episode covers why coaching must be uncomfortable to produce real change, why self-coaching runs into the limits of blind spots and self-bias and where AI coaching tools genuinely help and where they fall short.Key HighlightsCoaching is a partnership exploring a client's own thinking, not advice or mentoring.The parallel between coaching and statistical consulting: determining the real goal behind a request.Why effective coaching must feel uncomfortable to produce genuine progress.The limits of self-coaching, and why blind spots require an outside challenger.How sports and performance coaching shifted from instruction to inquiry.Where AI coaching helps and where human presence and challenge remain irreplaceable.The difference between coaching and therapy: forward-facing versus backward-facing.For more, visit us at https://www.berryconsultants.com/
- Sep 14, 202645 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 fixed duration. Roger, Anna, and Nick walk through the monotonic dose-response model that governed escalation, an unplanned mid-trial complication when the FDA independently authorized fourteen-day cold storage, and how the Data Safety Monitoring Board reviewed results within days of each interim. The trial ultimately demonstrated non-inferiority of cold-stored platelets out to twenty-one days with a Bayesian probability greater than 99.9%, offering a path to expanding platelet access in settings where it was previously very challenging.Key HighlightsCold-stored platelets tested as a potential answer to platelet shortages in rural, low-volume, and military/disaster settings.Bayesian adaptive design used to find the maximum safe cold-storage duration, not just test a single fixed duration.A monotonic dose-response model constrained escalation to a pre-specified, safety-first ladder across four interim analyses.Mid-trial complication: an independent FDA decision allowing 14-day cold storage, absorbed into the design without unblinding.Non-inferiority demonstrated out to 21 days of cold storage, with a Bayesian probability greater than 99.9%.Interim data turned around by the unblinded implementation team in five business days, versus the six weeks often assumed for adaptive trials.Implications for platelet access in disaster, military, and low-volume hospital settings, and for how shelf-life-dependent products are tested going forward.For more, visit us at https://www.berryconsultants.com/
- Sep 7, 202638 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 episode on the CTE study's central flaw: because CTE can only be diagnosed after death, the published prevalence is calculated from a sample of deceased players rather than the full population of NFL players — a distinction he illustrates using a thought experiment on sudden infant death syndrome (SIDS) and a breakdown of the study's own age-stratified death data. He traces the resulting bias, a form of differential mortality, to a single caveat buried deep in the study's limitations section.Key HighlightsAdventist Health Study-2's "27% fewer Alzheimer's diagnoses in egg-eaters" finding, and why it's likely multiplicity-driven and observational, not causal.The Emory University vitamin D study (Zhao et al.): a 13% MoCA improvement drawn from roughly eight patients, presented as a headline finding.The British Medical Journal NFL CTE study (Danishvar et al., Harvard / Boston University): a headline prevalence of "25% to 97%" of NFL players.Why 215 of 235 donated brains (97.7%) is a hugely biased numerator — CTE is only diagnosed posthumously, and families of symptomatic players are most likely to donate.The corrected denominator: 878 NFL players who died between 2016 and 2021, yielding roughly 24.5% — still biased, because CTE itself accelerates death.A SIDS thought experiment showing how building a "population" from those who have already died systematically overstates prevalence through a form of differential mortality bias.The key limitation, buried three-quarters of the way through the paper's limitations section, quietly mentions the selection bias behind the headline number.For more, visit us at https://www.berryconsultants.com/
- Aug 31, 202647 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 interpreting the mean difference using patient-level minimal effects, and adopt responder analyses and cumulative probability approaches to enhance patient-level relevance. Guidance is offered for analyzing the effect of time-saved instead of a mean differences in a clinical endpoint at a single time for progressive diseases – measuring “sweet time.”Key HighlightsFocus on added time not the change from baseline as the most meaningful outcome for a progressive disease.In-depth evaluation of MCID, CSD, TPP, and risk of misinterpretation.Critique of trying to interpret mean-based endpoints for clinical meaningfulness such as six-minute walk distance and CDR sum of boxes.FDA advisory panel guidance on MCID for IVF live birth endpoints and dichotomous versus continuous endpoints.Advocacy for responder analyses and cumulative probability of achieving thresholds in reporting the clinical effect of a treatment.For more, visit us at https://www.berryconsultants.com/
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About 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 clarity, foster debate, and challenge mainstream perspectives, ensuring you remain at the forefront of clinical trial excellence.
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