HAMILTON, N.J., Dec. 7, 2010 /PRNewswire/ — 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 desc