Case Study: Merck achieves 41% reduction in standard deviation and superior data quality with Clario ePRO

Merck Research Laboratories Reduces Standard Deviation With Electronic Pro

Merck Research Laboratories ran a randomized, parallel “Comparison Study” to test whether electronic patient‑reported outcomes (ePRO/eDiary) yield higher‑quality, more analyzable data than paper diaries. For the electronic arm, Merck partnered with Clario, using Clario’s ePRO/eDiary services to capture daily Morning Questionnaires and other patient‑reported measures in a multicenter trial of ~90 patients.

Clario deployed handheld ePRO capture with time‑stamping, skip logic and real‑time validation, which produced substantially cleaner data: the ePRO arm (46 patients) showed a 41% lower standard deviation in Total Sleep Time, far fewer data point changes (48 vs. 204) and fewer data clarification forms (30 vs. 66) versus paper (44 patients). By reducing variance and corrections, Clario’s ePRO solution increased study power and enabled equivalent confidence with fewer than half the number of patients.

Merck