Feasibility of a new electronic patient-reported outcome (ePRO) system for an advanced therapy clinical trial in immune-mediated inflammatory disease (PROmics): protocol for a qualitative feasibility study.

ABSTRACT:

Introduction

The use of electronic patient-reported outcome (ePRO) systems to capture PRO data in clinical trials is increasing; however, their feasibility, acceptability and utility in clinical trials of advanced therapy medicinal products (ATMPs) are not yet well understood. This protocol describes a qualitative study that aims to evaluate the feasibility and acceptability of ePRO data capture using a trial-specific ePRO system (the PROmics system) within an advanced therapy trial involving patients with immune-mediated inflammatory disease (rheumatoid arthritis, lupus, primary sclerosing cholangitis (PSC) and Crohn's disease).

Methods and analysis

This protocol for a remote, qualitative, interview-based feasibility study is embedded within the POLARISE trial, a single-arm

SUBMITTER: Hughes SE 

PROVIDER: S-EPMC9453996 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature