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.

"Digital twin" is now applied to almost any model that predicts a patient's outcome. This latest blog separates three kinds of models and what each can replace in a clinical trial. In addition, we also make the case that virtual controls should provide a full predictive distribution for each patient rather than a single forecast.

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.

Conventional clinical trials are stadiums built from scratch for a single contest and dismantled the moment it ends, which accounts for much of what they cost and how long they take. Platform and basket trials replace that pattern with a standing arena, and when the structure stays up the arithmetic changes for arms, sponsors, sites, regulators, and above all, 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.

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.