Electronic patient-reported adverse event monitoring in academic early-phase clinical trials: a feasibility study

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Twenty-three participants consented (76.7% consent rate), 18 remained on study at 12 weeks (4 were withdrawn due to toxicity and 1 patient choice).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)