MedAvante to Deliver Remote, Expert Patient Assessment in $25 Million, Innovative NIMH Study of Early Schizophrenia Treatment
HAMILTON, N.J., Jan. 14 /PRNewswire/ — MedAvante, Inc., the leader in centralized evaluation of central nervous system (CNS) disorders, announced today that it has been contracted to provide psychiatric rating services for a five-year, $25 million study of schizophrenia sponsored by the National Institute of Mental Health (NIMH). The multi-center study is part of the NIMH-funded Recovery After an Initial Schizophrenia Episode (RAISE) project, and is being led by a group of researchers at the Feinstein Institute for Medical Research in Glen Oaks, NY and a team of researchers across the United States.
The study will use MedAvante’s Remote Centralized Ratings(TM) Services, the company’s proprietary methodology for reducing the risk of failures in CNS clinical trials. In the RAISE project, the study team will connect subjects with MedAvante’s comprehensively trained, centrally located, independent raters who interview patients by live, two-way videoconference to assess how well the treatment works.
“Research has shown that centralized raters who are well trained and are removed from a research site are more accurate and more reliable judges of who qualifies for a study as well as the effectiveness of an intervention,” said Paul Gilbert, Chief Executive Officer of MedAvante. “The RAISE project offers an ideal setting for the use of our service, allowing the lead investigators to ensure assessment quality and standardization in this important study of patients who are dealing with their disease in the real world: their own communities.”
The study will focus on improving the outcome of early phase schizophrenia by ensuring that a full range of interventional options are available following diagnosis. These options include medications, psychosocial treatments and supported employment/education. In addition, information on how to best manage the disease will be provided to families. A comparison group of patients receiving usual care in the community will be included in the trial.
For this study, MedAvante’s clinicians will be co-located in one center and will use high-quality, two-way videoconferencing to first determine which patients meet the criteria for the trial and then follow enrolled subjects for at least two years. Raters will not know which intervention each patient receives. Using MedAvante’s centralized team of expert clinicians is essential to follow schizophrenia subjects in “real-world settings.” Previously, participants in studies had to travel to or be able to regularly visit major medical centers to be assessed. Being able to remotely access an expert to perform the assessment regardless of the patient’s location means RAISE may identify and include many more appropriate subjects.
“The MedAvante methodology enables us to employ clinicians who are highly trained in conducting research assessments across a wide range of community centers,” said Nina R. Schooler, Ph.D., Professor of Psychiatry and Behavioral Sciences at SUNY Downstate Medical Center in Brooklyn, one of the lead investigators for the RAISE study. “The sites in this study do not all have the same level of experience with clinical trials in schizophrenia. MedAvante gives us a cost-effective way to be sure that all patients receive the same high-quality evaluations and diagnostic assessments. The alternative – hiring, training and maintaining a large cadre of expert clinical raters for each community outreach center – would have been cost prohibitive.”
In addition to cost benefits, the MedAvante methodology offers significant improvements in data quality. “Employing the MedAvante methodology enables us to establish and sustain the highest levels of inter-rater reliability, quality control, and accuracy as well as lack of bias,” said Dr. John Kane, the lead investigator for the study, Chairman of the Department of Psychiatry at The Zucker Hillside Hospital in Glen Oaks, NY, and Chief Scientific Advisor and shareholder of MedAvante.
The project has been funded in whole or in part with Federal funds from the American Recovery and Reinvestment Act of 2009 and the National Institute of Mental Health, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN271200900019C.
MedAvante is the premier global provider of centralized expert psychiatric rating and monitoring services to the pharmaceutical, biotechnology and medical device industries. Centralizing raters makes it possible to continuously train and calibrate a smaller group of clinicians, which improves consistency and accuracy of the assessment of symptoms. The resulting level of standardization is not achievable with a larger group of decentralized raters participating from unconnected study sites. The company offers a range of services, including assessment of patients via high-quality videoconferencing and quality control for trials via review of videotaped ratings. Raters who are independent of the site enrolling the patients may also be more objective assessors of symptoms. MedAvante’s research has shown that these improvements reduce trial failure rates, one of the most serious challenges facing the development of new psychiatric and neurologic treatments. MedAvante operates facilities in Hamilton, NJ; Los Angeles; Madison, WI; and Moscow, Russia.
SOURCE MedAvante, Inc.