MedAvante, Inc., the leader in centralized expert evaluation of central nervous system (CNS) disorders, and Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN) a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, announced that Rexahn will use MedAvante 's Remote Centralized Ratings™ in their randomized, double-blind, placebo-controlled Phase 2b clinical study assessing the efficacy of Serdaxin® in patients with major depressive disorder (MDD). MedAvante's centralized ratings were chosen to reduce bias and variability associated with CNS trials.
Rexahn is the latest in a growing number of pharmaceutical companies deciding to use centralized raters, who are free of study biases, for CNS trials. This approach has empirically demonstrated the ability to reduce rater variability and the placebo effect.
Centralized assessments in other therapeutic areas, including oncology, imaging and cardiovascular, are used to reduce bias and minimize variability and have been described affirmatively in regulatory guidance documents. Now centralized calibrated raters conducting real-time psychiatric assessments are achieving the same benefits for sponsors of CNS studies.
Rexahn's Serdaxin is a well characterized chemical entity tested for multiple CNS indications. Data from a Phase 2a study in MDD has shown that Serdaxin has the potential to improve symptoms of depression, without the side effects commonly associated with currently marketed antidepressants.
"As a company seeking to develop and deliver new treatments for CNS disorders, it is vital that we design and conduct clinical trials that maximize rater objectivity and standardization," said Rick Soni, President and Chief Operating Officer of Rexahn.
"By their nature, depression trial results can be affected by any number of variables, especially when subjective assessments are used. That is why having central raters who are continuously monitored and calibrated can minimize rater bias," said Soni. "We carefully evaluated different methodologies and found MedAvante Remote Centralized Ratings far superior to traditional methods."
"Centralized ratings are the wave of the future in clinical testing of CNS drugs," said Paul M. Gilbert, Chief Executive Officer of MedAvante. "Our centralized ratings are backed with extensive clinical operations experience, professional project management capabilities, and proprietary infrastructure – all working together to fit seamlessly into Rexahn's existing study research design.
"We are confident that our unique ability to deliver 'true' centralized ratings can significantly reduce the bias and ratings variability associated with typical CNS trials – thereby providing a true reflection of both treatment and placebo effect," said Gilbert.
MedAvante's centralized raters diagnose subjects and evaluate symptom severity to ensure appropriate patient ascertainment and post-baseline standardization, the most difficult challenges to signal detection in CNS studies. The raters are mental health professionals with deep clinical and rating scale expertise, carefully selected through an intensive qualification process, and continuously trained and calibrated to ensure optimal inter-rater reliability and minimize rater drift, a factor leading to inconclusive results in CNS trials.
Having set up over 600 remote sites worldwide, MedAvante supports each with a robust rater scheduling system to ensure blinding, and 24/7 global technology support. MedAvante automated systems are 21CFR (part 11) certified and data privacy protection is US/EU Safe Harbor compliant.
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