MedAvante Research Shows Improved Psychiatric Assessments in Clinical Trials
Virgil eCOA Reduces HAM-D Item Scoring Errors Up To 70%
Scottsdale AZ (June 1, 2016) – MedAvante, Inc., the leading global scientific clinical data services company, today presented research at the 2016 American Society of Clinical Psychopharmacology (ASCP) meeting quantifying error reduction in actual clinical trials of treatments for major depressive disorder (MDD). The new study compares traditional paper-based assessments in clinical trials with the Virgil® Investigative Study Platform, which uses a digital tablet to administer and score clinical outcome assessments (eCOA) and capture source data (eSource).
“This was our first opportunity to compare Virgil eCOA to paper for the widely used Hamilton Depression Rating Scale (HAM-D),” said study co-author Janet B.W. Williams, PhD, Senior Vice President of Global Science at MedAvante and Professor Emerita at Columbia University. “Virgil, which provides clinical guidance during scale administration, substantially reduced error rates, particularly in scoring the core symptoms of MDD.”
“More than twice the number of HAM-D assessments administered with Virgil had no scoring discrepancies compared to paper-based administrations,” said Williams. “Virgil administration also resulted in consistently lower error rates across the vast majority of item-level scores, reducing the number of scoring discrepancies between 50 and 70 percent in the core items of depression and anxiety.”
The MedAvante research analyzed data sets from two MDD clinical trials, both of which used the structured interview guide for the 17-item HAM-D (SIGH-D), concluding that paper-based administration creates unnecessary variability in endpoint measurements which contribute to error variance and add noise around the signal.
“Virgil administration, with real-time clinical guidance, auto-calculation of scores and prompts for missing data and out-of-range errors, can improve signal detection,” said Williams. “This is clearly important for clinical trials in MDD that suffer from very high failure rates that are due in part to unreliable psychiatric assessments.”
A full summary of the research findings can be found at http://goo.gl/7gEHCH
About MedAvante, Inc.
MedAvante is a global clinical data services company dedicated to maximizing signal detection in clinical trials. Founded in 2002, MedAvante pioneered Central Ratings, a groundbreaking clinical trial methodology. This heritage of clinical expertise, coupled with technical innovation and operational skills, enabled MedAvante to develop the electronic source (eSource) platform, Virgil, the first such technology to replace costly and error-prone paper rating scales with real-time digital collection and cloud management of source data. Designed by clinicians for clinicians, Virgil offers built-in clinical guidance to ensure accurate, standardized assessments. MedAvante helps brings better drug therapies to market through smarter, faster clinical trials. Based in Hamilton, NJ with operations teams in the US, Germany, Russia and Japan, MedAvante delivers services for clinical trials in more than 40 countries worldwide. For more information, please visit www.medavante.com.
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