In a Phase IV, three-year study, Almirall is evaluating the long-term safety of a topical treatment for patients with actinic keratosis. The study requires patients to report outcomes periodically and avoid sunlight or UV light exposure. Therefore, tracking participants’ UV index (UVI) exposure is crucial to minimize the risks of overexposure, especially during the spring and summer seasons. Almirall wanted to provide patients with a wearable device option to measure UVI. This measurement is essential for raising awareness about the risks of excessive UV radiation exposure and for alerting them to adopt protective measures.
Enrollment began in November 2022, and the study is still ongoing. This case study focuses on the results obtained from the initial analysis.
Challenge
Approximately 30% of the patients who participate in a clinical trial drop out of the study, according to industry estimates.
Solution
Trial Online is an integrated platform that enables collecting clinical trial data such as eDiaries and ePROs.
Keeping in mind the cultural and technological environment of our patients and providing a paper back up version of the questionnaires, Trial Online provided Almirall’s patients a platform through which they were notified and reminded to complete the required questionnaires, they could ask for support and have a virtual visit with the healthcare professional and track their own performance and compliance with the study. All of this drizzled with a little bit of fun.
Gamification. In order to provide the patients with a more engaging experience during the clinical trial, on Trial Online patients can see and track their activity progress and their compliance. Patients can compare their progress in relation to the study by joining competitions and receiving badges for achievements.
Results
Almirall closely observed the adoption and benefit of Trial Online in a phase III actinic keratosis clinical trial involving 20 US clinical sites (105 patients, average age of 69 years old) with a study duration of 8 weeks.
The following exceptional results were identified.
93%
Patient Retention
78%
Used Trial Online
100%
Downloaded Trial Online
69%
eDiary Compliance
94%
diary completion between eDiary and paper version
