A critical review of the use of electronic patient-reported outcomes in cancer clinical trials – developing an EORTC perspective

Patient reported outcomes (PROs) are increasingly collected and used electronically in clinical trials. Such collection is often referred to as ePRO data capture. Compared to traditional paper-based assessment, ePRO assessment may offer different benefits (e.g., improved data quality, more control over the correct assessment and timing of PROs, improved audit capabilities).

There is little systematic research on how and how often electronic PRO data capture is used in cancer clinical trials. It’s unknown, what best practices exist and how electronic methods can best be used to support patients in completing PRO measures.

This project aims to review the current state of electronic PRO data capture in cancer clinical trials. In the second stage of the project, an expert panel will help draft an EORTC QLG perspective paper on how ePRO methods should be used to ensure high data and overall trial quality.

The project started in Mid-2023.

• • A protocol for the systematic scoping review assessing the different modes of assessment of PROMs in clinical trials has been published.
  • The first phases of the scoping review have been completed and full data extraction is ongoing.
  • The EORTC member survey was launched in November 2023 via the EORTC Y-ECI network and distributed to all members. The survey is now closed and a publication is currently being prepared. We expect to submit the publication Q4 2024.
  • Interviews with different trial stakeholders are ongoing.

• Systematic scoping review of the of different modes of assessment of PROMs in clinical trials (finalizing)
• Interviews with different stakeholders on different modes of assessment (ongoing)
• Expert consensus process to discuss experience with ePRO use, expectations towards ePROs, and opinions on ePRO data capture in clinical trials (planned/in preparation)

Questionnaires of patients’ perception of their own health status are an important part of clinical research. Clinical studies often use different methods to distribute questionnaires to patients. For example, studies may distribute paper-pencil questionnaires or patients may be able to complete questionnaires electronically via a website.

In this project, we research how those different assessment methods are currently used in clinical research, how they differ from each other and what their benefits and drawbacks may be.

The goal of this project is to make it as easy as possible for patients to share their health status in clinical trials and to help establish best practices for the use of electronic assessment methods in clinical trials.