How an Innovative Statistical Methodology Enables More Patient-Centric Design and Analysis of Clinical Trials

ACRP

Clinical trials are critical for assessing new treatments in terms of their potential benefits for patients’ health and for their likelihood of financial success if marketed. Yet, the traditional approach focusing on a single primary endpoint may mean lengthy trials that often fail to capture the full spectrum of the treatment effects that are crucial to patient well-being. Generalized pairwise comparisons (GPC) is an innovative statistical methodology that offers a revolutionary approach to clinical trial analysis, addressing these shortcomings by allowing the integration of multiple clinically relevant outcomes into a single assessment. This methodology better leverages the large amount of collected data and improves clinical trial efficiency by reducing the required sample size. Multiple case studies have demonstrated the successful application of GPC in regulatory submissions, with notable U.S. Food and Drug Administration (FDA) approvals in cardiovascular disease.

This paper discusses the benefits of GPC, providing a compelling argument for its broader adoption in clinical research to meet modern healthcare challenges, design patient-centric protocols, and approve patient-centered treatments at a faster pace. Read more…