MedAvante, Inc., the leader in centralized expert evaluation of treatments for central nervous system disorders, announced that Cipher Pharmaceuticals is using MedAvante Centralized Ratings in their pivotal Phase 3 dermatology study.
Cipher recently announced the completion of the patient enrollment phase of their clinical study, in which every patient is interviewed by a qualified MedAvante mental health expert at every visit of the study. MedAvante centralized raters are monitoring each patient’s well-being to determine if any changes in mental status are detected while on medication.
The Cipher study is the first time MedAvante Centralized Ratings are being used to assess the safety and potential for psychiatric side effects of a non-psychiatric drug being studied in an ambulatory setting. Regulatory authorities have been requesting that companies evaluate the propensity of a non-psychiatric treatment to affect a patient’s well-being as part of product development for certain pharmaceuticals.
“Clinical studies require specialized and sophisticated methodologies that are highly accurate and reproducible, and at the same time capable of assuring patient safety,” said Dr. Jason A. Gross, Vice President of Scientific Affairs at Cipher. “We examined other methodologies of evaluating psychiatric events, including automated self-report systems,” he said. “However, we found that only the MedAvante Centralized Ratings were able to provide the critical attributes of consistency and accuracy that the FDA and Cipher required.”
“Our work with Cipher is evidence that centralized ratings can be beneficial to many types of clinical testing,” said Paul M. Gilbert, Chief Executive Officer of MedAvante. “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. We believe we achieve the same benefits with centralized psychiatric assessments,” he said.
The Cipher study has required MedAvante centralized raters to conduct over 8,100 remote, live assessments of patients at 50 sites in the U.S. and Canada, and to report timely results to the sites. “MedAvante’s role in the Cipher study demonstrates our ability to seamlessly integrate centralized raters into most non-psychiatric studies, by providing responsive operational logistics and without interfering in standard study procedures earning the acceptance of the dermatologists in the study,” said Gilbert.
MedAvante’s centralized raters are mental health professionals with deep clinical and rating scale expertise, carefully selected through an intensive qualification process, and continuously trained and calibrated.
Source: MedAvante, Inc