Electronic Collection of Patient-Reported Outcome Measures in Dermatology Trials

OBJECTIVES: Patient-reported outcomes (PROs), such as diaries or questionnaires, can be collected using electronic devices during the course of a clinical trial. Data gathered via ePROs that shows a new medication improves participant’s outcomes, supports regulatory submissions. Impact of a medication on PROs is important in dermatology space because skin diseases affect participants’ lives in a negative way. The aim of this research was to perform a review and analyze the use of ePRO instruments in dermatology trials.

METHODS: 35 dermatology trials were identified in the sample of 506 studies. PRO instruments in those trials were characterized in terms of a phase of a trial, endpoint hierarchy, study population, and data collection modality (tablet vs handheld).

RESULTS: Among 35 identified trials 100% collected PROs. PROs supported the following outcomes: primary in 3 trials, key secondary in 8 trials, secondary in 15 trials, and exploratory in 9 trials. For the trials that are completed, and PROs supported primary and/or key secondary outcomes, 86 % gained FDA approval. Electronic diary was used in 46 % of the analyzed trials and in 71 % of the completed trials supporting primary and/or key secondary outcomes. Tablet was used for data collection in 100 % of the trials and handheld device was used in 46 % of the trials.

CONCLUSIONS: Our analysis shows that around 30 % of PROs in 35 trials supported primary and/or key secondary outcomes. Tablet was used for PRO data collection during site visits and handheld was utilized for daily data collection. Generally, when dermatology trials utilized PRO instruments, almost 50% of these studies used an electronic diary to collect data.