ArticleClinical trials (London, England)2026
Electronic patient-reported adverse event monitoring in academic early-phase clinical trials: A feasibility study.
Article in Clinical trials (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03461939 (Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences (ePRIME): Collection of Patient-reported Adverse Events in Early Phase Clinical Trials in Yorkshire
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdverse 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.
methodsA 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.
resultsTwenty-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.
conclusionsRemote 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 registrationClinicalTrials.gov ID: NCT03461939 (first registered: 05/03/2018).
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