In the Interim...

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.

Publisher

Berry

Category

health & fitness · science

Language

en

Explicit

No

First episode

18 Feb 2025

Latest episode

12 Oct 2026

Latest episodes

1 of 81 episodes have a transcript.

1. 

   12 Oct 2026

   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 Highlights Reserving "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 (https://www.berryconsultants.com)

2. 

   28 Sept 2026

   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 Highlights The 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/ (https://www.berryconsultants.com/)

3. 

   21 Sept 2026

   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 Highlights Coaching 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/ (https://www.berryconsultants.com/)

Inside a recent episode

The SNAP Trial with Professors Tong and Davis

Published 16 Mar 2026 · Transcript excerpt

[…] It causes a mortality rate of 20 to 25 percent per episode. So it's a big deal. And so it's important to study as infectious diseases clinicians, we've seen lots of this. So here every week, you know, hospital wear on clinical service, we're seeing, you know, two or three occasions per week with this condition. And so it's one that really needs to study to try and improve outcomes. That mortality rate of 25 percent or so per episode has to be stuck at that. So probably the last 30 to 40 years, I think, and we haven't seen improvements in our therapeutics for staff bacteria in it. So what, so you're talking to a statistician here, but what does it mean to have a bloodstream infection? […]

Who has been a guest on In the Interim...

Names identified in recent episode analyses. Showing up to five guests.

• Jenny Devenport
• Dr Kaspar Rufibach
• Dr Don Berry
• Dr Lindsay Berry
• Dr Nick Berry

Reach and audience

Public platform figures. Ratings count people who left a rating, not total listeners.

Apple Podcasts (US)

5.0 / 5

16 ratings

Spotify

4.9 / 5

12 ratings

Podcast Authority Score: 59 / 100

A composite of feed quality, social presence, YouTube performance and engagement. Read the methodology.

Quality

98

Social presence

0

YouTube

0

Engagement

51

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Guest appearances

Books guests

Based on episode analysis; this does not confirm that the show is currently accepting guests.

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