Expert Analysis Of Rater Discrepancies Allows Sponsor To Demonstrate Efficacy—Even With A Missing Endpoint

The Challenge
A small neuroscience pharmaceutical company conducted a 28-day Phase II proof-of-concept clinical trial in 95 patients with a movement disorder.
But there was a problem: The primary study endpoint using remote video assessment failed to meet significance at Day 28. However, using the same scale, investigators who observed the patients in person did find significant improvement in treated patients at Day 28 when compared to placebo. They used the same scale.
The company turned to WCG MedAvante-ProPhase for guidance and expertise, asking to re-analyze the primary endpoint data from all sources.