By Amy Ellis, President and Co-Founder, MedAvante
When Paul Gilbert and I founded MedAvante, we had a simple but ambitious goal: to improve the success of clinical trials in CNS and psychiatry.
So we enlisted the help of two expert clinicians: Dr. Janet Williams (now Senior Vice President, Global Science at MedAvante) and Dr. Ken Kobak (now a MedAvante Senior Scientist).
Williams and Kobak had earned their academic reputations by tackling a thorny problem: subjectivity in CNS and psychiatric assessments. Raters performing outcome assessments introduce bias and measurement variability into trial data unless they adhere to common, accepted standards. By applying standard conventions for rating scales and creating standardized training for raters, Williams and Kobak devised methods to guard against these pitfalls.
Their work, we quickly saw, had significant implications for the revolutionary methodology we were developing to improve data quality: Central Ratings. By using a standardized cohort of identically trained raters, Central Ratings ensures that assessments are performed to a common standard at sites around the globe. By integrating Williams and Kobak’s training methods and guidance, we enabled central raters to adhere even more closely to assessment protocols.
While Central Ratings was a major development in the way CNS trials are conducted, part of MedAvante’s mission to improve clinical trials includes making clinical guidance—and other methods of standardizing assessments and improving data quality—easily accessible to sites and sponsors.
Real-Time Access to Clinical Guidance: The Virgil eSource Platform
MedAvante’s Virgil eSource platform represents the next step in that mission. eSource, which has been recommended by FDA guidance, allows sites to streamline workflow with digital data capture. MedAvante uses eSource not only to eliminate paper and improve data quality, but also to ensure that clinical standards are applied across trial assessments to reduce bias and variability.
The Virgil eSource platform delivers real-time access to the interview guides developed and standardized by the scientists and clinicians who established Central Ratings as the gold standard in CNS and psychiatric trials.
Because Virgil collects and analyzes data in real-time, it flags instances where ratings deviate from expected norms, where bias may have seeped in to the assessment process. Principal investigators have the chance to stop “rater drift” before it compromises data.
Today, plenty of technology companies are dabbling in eSource for clinical trials. But they see eSource through a technological lens; our perspective is clinical. Virgil was built from the combined expertise of more than 200 in-house clinicians and software engineers. As a clinical company, MedAvante uses its technology to ensure that clinical standards are met and trial outcomes are enhanced.
The benefits of applying technology to clinical trials are minimal unless they are tooled to drive efficiency and improve clinical data quality. eSource platforms should not be viewed simply as technology solutions, but rather as drivers of improved clinical outcomes. eSource has the potential not only to improve day-to-day workflow, but to minimize bias and improve outcomes in clinical trials.