Case Study: Large Biopharmaceutical Company achieves over 50% reduction in placebo response with Clario eCOA patient training

Training Program Reduces Placebo Effect By More Than 50% In Epro Study

Large Biopharmaceutical Company ran an eight‑month Phase III CNS migraine study in the US with about 1,400 patients and needed to show its treatment was statistically differentiated from placebo on two co‑primary endpoints. Because migraine trials typically face high placebo response rates (around 29%), the sponsor engaged Clario to reduce placebo effects and protect the trial’s ability to detect true drug benefit using an eCOA‑based patient training approach.

Clario implemented a tailored, mandatory online multimedia patient training program (English and Spanish) with a comprehension quiz and integrated eCOA handheld delivery of the Migraine Quality of Life and Profile of Moods ePROs plus reminder alarms; training covered participant roles, device use, and how to answer symptoms to minimize placebo effect. The result: Clario’s training cut the placebo response rate by more than 50%, helped the Large Biopharmaceutical Company demonstrate statistical differentiation from placebo on both co‑primary endpoints, and supported high compliance and timely site follow‑up.