ISCTM to develop solutions for CNS clinical trial methodology

ISCTMOct 21 2010

The International Society for CNS Clinical Trials and Methodology (ISCTM) met recently to develop solutions to challenges facing CNS clinical trial methodology. A day was devoted to addressing treatments for cognitive impairment in persons with schizophrenia at a session entitled "MATRICS Update and Beyond." Speakers from industry, academia, NIMH and regulators from the US and Europe focused on the strengths and limitations of the data from recent studies using methodology recommended by the MATRICS consensus process, and refinements in methodology that may facilitate the development of drugs for cognitive impairment in schizophrenia and other disorders. "The MATRICS initiative was instrumental in stimulating research on drugs for cognitive impairment in schizophrenia," said Dr. Stephen R. Marder, Professor of Psychiatry at the Semel Institute for Neuroscience at UCLA. "Although the FDA and European regulators view the cognitive assessment methodology proposed by MATRICS as the gold standard for schizophrenia trials, research in cognitive neuroscience has demonstrated that new methods may be able to be applied to early phase drug development programs."

“This session took important steps towards addressing these complex issues.”

At a half-day workshop entitled "Suicidality Assessment in Clinical Trials: Methodological and Technical Challenges" attendees worked towards consensus on the best ways to address challenges of prospectively monitoring for suicidal thinking and behavior in clinical research. "Prospectively identifying suicide risk presents critical methodological challenges," said Dr. Larry Alphs, president of ISCTM. "This session took important steps towards addressing these complex issues."

The DSM-5 version of the American Psychiatric Association (APA) Diagnostic and Statistical Manual is planned for publication in 2013. The final ISCTM session reviewed the status of diagnostic changes for mood and psychotic disorders. It featured presentations by the APA workgroups and commentaries from US and European regulators. "Designing clinical CNS trials to address medical needs using our most advanced thinking on diagnostic classification is critical for researchers, clinicians and patients. ISCTM will continue to critically assess the work of the DSM-5 Task Force going forward," said session organizer Nina R. Schooler, PhD.

The ISCTM gathers representatives from clinical and academic specialties, the pharmaceutical industry, and regulatory bodies to evaluate critical clinical and public-health challenges twice annually. It examines the development of novel treatments for major psychiatric and neuropsychiatric disorders and works to support advances in methods for evaluating treatments that are scientifically sound, ethical, and feasible. The 7^th Annual Scientific Meeting, (including a National Mental Health Research-to-Policy Forum) will be held 21-23 February 2011, at The Fairmont, Washington D.C.