A rigorous review of ordinal endpoint analyses, showing every approach—utility weighting, proportional odds, dichotomization, or non-parametric—inevitably assigns relative weights to outcome states. Berry Consultants’ mathematical demonstration reveals how proportional odds analysis embeds prevalence-based weights, underscoring the need for transparency and clinical input in trial design.

In this episode of "In the Interim…", Dr. Scott Berry and Dr. Lindsay Berry investigate the statistical foundations and clinical implications of analyzing ordinal endpoints, drawing on experience from major stroke and COVID-19 trials. Discussion centers on the Modified Rankin Scale, DAWN, MR CLEAN, and REMAP-CAP.

In this episode of "In the Interim…", Dr. Scott Berry marks the podcast’s one-year anniversary, sharing listener metrics, watch data, and regional engagement. He then delivers a step-by-step analysis of the FDA meeting process, detailing the progression from initial sponsor meeting requests and question submission to briefing book preparation, feedback cycles, and in-person logistics.

Dr. Nathan O’Hara (University of Maryland), Dr. Gerard Slobogean (UC Irvine), and Dr. Sheila Sprague (McMaster University) describe the launch and design of the Musculoskeletal Adaptive Platform Trial (MAPT)—the first major adaptive platform trial in orthopaedic surgery.

In this episode of "In the Interim…", Dr. Scott Berry speaks with Dr. Michael Harhay, Associate Professor at the University of Pennsylvania and Director of the Center for Clinical Trials Innovation.

The FDA Draft Bayesian guidance is a dramatic leap forward for Bayesian clinical trials and regulatory science. In this blog, Dr. Kert Viele outlines the key concepts and motivations for the guidance recommendations.