Statistical considerations when estimating time-saving treatment effects in Alzheimer's disease clinical trials.

ABSTRACT:

Introduction

Estimating treatment effects as time savings in disease progression may be more easily interpretable than assessing the absolute difference or a percentage reduction. In this study, we investigate the statistical considerations of the existing method for estimating time savings and propose alternative complementary methods.

Methods

We propose five alternative methods to estimate the time savings from different perspectives. These methods are applied to simulated clinical trial data that mimic or modify the Clinical Dementia Rating Sum of Boxes progression trajectories observed in the Clarity AD lecanemab trial.

Results

Our study demonstrates that the proposed methods can generate more precise estimates by considering two crucial factors: (1) the absolute

SUBMITTER: Wang G 

PROVIDER: S-EPMC11350030 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature