Clinical and Regulatory Challenges of Applying Personalized Medicine to Clinical Trials for CNS Diseases Are Addressed at ISCTM Meeting
October 16, 2009 09:47 AM Central Time
SAN DIEGO–(BUSINESS WIRE)–A half-day session, on the application of the principals of personalized medicine to the development of improved treatments for central nervous system disorders, chaired by Larry Alphs, MD, PhD, Medical Affairs Johnson and Johnson and George Garibaldi, M.D., Clinical Development, Roche Pharmaceuticals was held on 6 October 2009, at the Autumn Meeting of the International Society for CNS Clinical Trials and Methodology (ISCTM) in San Diego, CA.
Recent advances in medicine, like the sequencing of the human genome, have yielded exciting new tools that promise to help physicians tailor treatments to individuals and their diseases. Dr. Alphs stated, “Personalized medicine represents the future of medicine around the world. This approach has revolutionary implications for industry sponsors of trials, the regulatory approval system and clinical practice.” At this session clinicians, statisticians and leaders from the pharmaceutical industry discussed the formidable challenges that must be overcome to realize the full potential of personalized medicine. This session reviewed some of the trial design and statistical approaches that might be adopted to address the particular challenges presented by a personalized medicine. Population-based and individual-based approaches to drug development were compared. Selection of suitable indications, study questions, study populations, and endpoints were identified as key areas for consideration when designing clinical trials with a “personalized medicine” goal. Dr. Nicholas Schork, Director of Research, Scripps Genomic Medicine Program, reviewed several statistical approaches that address the special challenges of personalized medicine trial designs. Dr. Steven Potkin, University of California, Irvine, presented his view of the implications of personalized medicine and how clinical practice may look in the future.
The ISCTM (www.isctm.org) was founded in 2004 to gather representatives from academic and clinical specialties, the pharmaceutical industry, and regulatory bodies to exchange ideas about important clinical and public-health challenges; to examine the development of novel treatments for major psychiatric and neuropsychiatric disorders; and to support advances in methods of evaluating such treatments that are scientifically sound, ethical, and feasible. To achieve this mission, ISCTM conducts two scientific meetings per year. The 6th Annual Scientific Meeting (including the National Mental Health Research-to-Policy Forum) will be held 22-24 February 2010, at The Fairmont, Washington D.C.
Contacts
ISCTM
Carlotta McKee, 615-383-7688
Executive Director
isctm@isctm.org