Clinical Trial Simulation in Diabetic Retinopathy: Insights from Patients and Site Staff.

ABSTRACT:

Introduction

High patient burdens from diabetic retinopathy (DR)-associated vision loss and intravitreal therapy (IVT) support patient experience inclusion in DR trial designs. This trial simulation characterized patient and site staff opinions to improve future nonproliferative DR (NPDR) trial designs.

Methods

Between March 27 and May 31, 2023, survey data were collected from trial simulation participants. After a preread and trial design animation, study features were simulated followed by a 75-90-min web-assisted telephone interview. Patients with NPDR and trial site staff from the United States, United Kingdom, and Germany were included. The likelihood of patient participation and the challenges faced by site staff in conducting the simulated clinical trial at their stud

SUBMITTER: Vujosevic S 

PROVIDER: S-EPMC12271008 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature