The US National Multiple Sclerosis Society and Critical Path Institute (C-Path) announced today that they have joined forces to launch the Multiple Sclerosis Outcome Assessments Consortium (MSOAC). This coalition of industry, academia, patient representatives, regulatory agencies, and the National MS Society will develop new standards for assessing outcomes in clinical trials of MS therapies. The MSOAC will collect, standardize, and analyze data from MS studies with the goal of qualifying a new clinician-reported outcome measure of disability as a primary endpoint for future MS trials.
"Robust clinical outcome measures are greatly needed to evaluate new treatments for MS," stated Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "The consortium approach pioneered by FDA and C-Path will facilitate a combination of available data and expertise to generate the best possible drug development tool." C-Path's President and CEO, Carolyn Compton, added that "C-Path consortia are 'action tanks' that tackle what no one organization can take on solo."... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/2479
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