Patient, clinicians and trial staff views on the online collection of patient-reported adverse events (AEs) in Early Phase Clinical Trials (EPCT): Phase 1 of the ePRIME study


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Fiona Kennedy1,Leanne Shearsmith1,Kathryn Gordon1,Julie Croft2,Sarah Danson3,Julia Brown2,ɢalina Velikova2
1University of Leeds,2University of ʟeeds,3University of Sheffield

Abstract

Background

As new treatment options are developed for patients living with advanced cancer, the importance of adverse events (AE) reporting in early phase clinical trials (EPCT) is essential. Past research suggests clinicians underestimate AEs, and the value of patient-reported outcome AEs (PRO-AEs) has been emphasised. Recent technology advances means the collection of real-time PRO-AEs is feasible and could enable automated alerts for severe symptoms.  Some recent EPCTs have started to explore PRO-AE collection, although most have used paper or waiting room tablets.  This study aimed to explore patients, clinicians and trial staff views of AEs in EPCTs, patient online self-reporting, and practical/ethical issues for a pilot study.

Method

Semi-structured audio-recorded interviews were conducted with 16 patients, 5 consultants, 4 research nurses and 7 trial staff. Qualitative analysis using a framework approach will be presented.

Results

Three overarching themes explored patient experiences of EPCTs, ECPT data collection and views on online patient self-reporting. Patients experienced AEs, but reporting to trial/clinical teams varied. Under-reporting mild symptoms and patient’s waiting until their next appointment was apparent but comprehensive reporting/recording for safety purposes was emphasised by staff. 11 patients were hypothetically willing to use an online AE system. Patient benefits included real-time reporting, and information for future patients. Reasons for not wanting to use a system included no internet (n=2) and feeling too well (n=1). Staff benefits were real-time recording, helping to prompt patients during trial-related visits, and capturing the breadth of lower grade (often unreported) toxicities. Practical issues/challenges included varying opinions between clinicians and trial unit staff on data flow, patient safety/using real-time notifications, determining causality of toxicities and variable internet use.

Conclusion

Technology advances mean it is timely to explore the benefits/challenges of patient online self-reporting of AEs in EPCTs. We have developed an online patient symptom reporting tool and a small pilot is underway.