Research
Concordant Rater Systems (CRS) is pleased to share the following research from our presentations. Our library of research in CNS studies is grounded in data results captured from industry studies using the products and services of the CRS Trial Management Lifecycle.
Posters
ISCTM 2010
Recipient ISCTM 6th Annual Scientific Meeting Distinguished Poster Award
Do Recruitment Sources Impact Study Outcome: Assessment by Computer and Site-based Rater
The CRS Rater Monitoring and Management solution captured and analyzed MADRS data from the tandem scoring of computer-administered and site-based rater assessments and determined that subjects entering a study from medical referrals vs. mass media showed greater drug-placebo separation and higher confidence in the diagnosis of bipolar I disorder. The use of quality metrics based on tandem ratings at baseline across all referral groups may provide stronger signal detection which helps mitigate the risk of failed studies.
Do Eligibility Criteria Really Matter?
In a post-hoc analysis, data captured and analyzed through the use of the CRS Subject Qualification solution, proves enrolling ineligible subjects in a study does impact results and can lead to study failure. By analyzing tandem ratings of computer-administered and site-based rater YMRS assessments at screening and baseline to determine eligibility criteria, the lack of observed efficacy of the compound suggests that the study was impacted by enrollment of many subjects that, based upon computer assessments, would not have met the protocol eligibility requirements. The use of the CRS methodology of tandem ratings between the site-based rater and computer for inclusion improves drug-placebo separation.
NCDEU 2009
A Computer Review to Increase Diagnostic Confidence for Bipolar Disorders
The CRS Subject Qualification solution using the computer-administered assessment to determine a bipolarity index score provides increased confidence of subject diagnoses and confirmation of subject eligibility in randomized clinical trials. Using this methodology, marginal subjects that are otherwise included in the study are excluded, and higher quality subjects are enrolled.
Reliability and Validity of Clinician and Computer-Administered MADRS Assessed in Randomized Controlled Trials
The CRS computer-administered MADRS, a validated instrument used in the CRS Rater Monitoring and Management solution, measures and monitors performance of site based raters and detects outlying raters, without breaking the blind, during the course of randomized controlled studies.