Electronic patient-reported adverse event monitoring in academic early-phase clinical trials: A feasibility study.
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All Authors
Shearsmith, L.
Danson, S.
Gelcich, S.
Gibson, A.
Gordon, K.
Collinson, F.
Croft, J.
Griffiths, E.
Rogers, Z.
Carter, R.
LTHT Author
Gibson, Andrea
Velikova, Galina
Velikova, Galina
LTHT Department
Oncology
Leeds Cancer Centre
Leeds Cancer Centre
Non Medic
Research Sister
Publication Date
2025
Item Type
Journal Article
Language
Subject
Subject Headings
Abstract
BACKGROUND: Adverse event monitoring is essential to monitor safety for oncology patients on early-phase clinical trials. Previous research considers that electronic patient-reported adverse events reporting is feasible and complementary to traditional clinician-led recording. An electronic patient-reported adverse event system was developed to explore the feasibility of this in early trials patients.
METHODS: A prospective single-arm feasibility study was undertaken at two recruiting hospitals. Participants were adult oncology patients who had recently (<1 month) started receiving a novel anticancer treatment on an academic early-phase trial and had access to the Internet. For a 12-week period, weekly reminders were sent to participants to complete an electronic patient-reported adverse event questionnaire remotely covering symptoms identified as relevant to the recruiting trials. The primary outcome was compliance (proportion of completed questionnaires/expected completions). Secondary outcomes included recruitment rates, attrition, electronic patient-reported outcome versus clinician-recorded adverse events, number of notifications, issues recorded, and patient acceptability.
RESULTS: Twenty-three participants consented (76.7% consent rate), 18 remained on study at 12 weeks (4 were withdrawn due to toxicity and 1 patient choice). Compliance with weekly electronic patient-reported adverse event was high, with a cumulative of 85.1% across the 12 weeks. Comparison with clinician-recorded adverse events showed electronic patient-reported adverse event resulted in wider coverage of adverse events: three times as many symptoms reported on electronic patient-reported adverse event (n = 174 last assessment) than recorded in the medical charts (n = 50 last record). End-of-study feedback indicated most patients reflected positively on their time on the study.
CONCLUSIONS: Remote electronic patient-reported adverse event reporting by patients in early-phase trials is feasible and acceptable. The study highlights some logistical challenges that require consideration in future electronic patient-reported outcome work to ensure adverse events are fully captured and recorded.
TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03461939 (first registered: 05/03/2018).
Journal
Clinical Trials