Project title: Real-time Electronic Patient Outcome ReporTing of adverse events in UK cancer trials (REPORT UK)

Project start date: January 2013

Anticipated end date: December 2015

Funding: Cancer Research UK

Background

Reporting of adverse events (AEs) is essential in clinical trials. The current system for AE reporting, the Common Toxicity Criteria and Adverse Events (CTCAE) relies on the clinician’s interpretation of patient symptoms. The importance and added value of patient self-reports on AEs and other Patient Reported Outcome Measures (PROMs) has been recognised by clinicians, regulatory authorities and health-care commissioners.