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agate Site Admin
Joined: 17 May 2006 Posts: 5694 Location: Oregon
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Posted: Wed Mar 27, 2013 12:52 pm Post subject: (AAN) MS Outcomes Assessment Consortium |
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Presented at the annual AAN conference in San Diego, March 16-23, 2013:
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[S31.001] The Multiple Sclerosis Outcomes Assessment Consortium: Accelerating Development of Treatments for Multiple Sclerosis
Nicholas LaRocca, New York, NY, Lynn Hudson, Tuscon, AZ, Richard Rudick, Cleveland, OH
OBJECTIVE:
The National Multiple Sclerosis Society (NMSS) has entered into a collaboration with the Critical Path Institute (CPath) to create the Multiple Sclerosis Outcomes Assessment Consortium (MSOAC). Its purpose is to analyze data collected during the course of completed MS clinical trials and observational studies with a goal of qualifying a new clinician- reported outcome measure as a primary disability endpoint for future MS trials.
BACKGROUND:
Successful development of disease-modifying drugs for relapsing forms of MS is a landmark achievement in neurotherapeutics. However, treatments that slow disability progression by inhibiting neural degeneration or promoting regeneration are lacking. This represents a significant unmet medical need.
Effective trial designs based on MRI lesions and relapses will not be optimal studies focused on disability progression. New, validated outcome measures focused on disability will be required. The US FDA has established a pathway to qualify new clinician-reported outcomes measures.
DESIGN/METHODS:
The MSOAC is a coalition of industry, academia, patient representatives, regulatory and other government agencies, and the NMSS. To achieve the goal, the MSOAC will create tools that will expedite and benefit the field of MS therapeutics. These include a pooled clinical trial database and a CDISC therapeutic data standard for MS.
In close collaboration with the FDA and European Medicines Agency (EMA), MSOAC members will contribute data and insights to arrive at a scientific consensus on an improved outcome measure. The coalition will be well-positioned for additional collaborative projects aimed at accelerating development of more effective treatments for MS.
RESULTS:
Participating companies, academic investigators, advocacy organizations, and regulatory agencies will be listed; details of the project plan, and current status will be presented.
CONCLUSIONS:
The MSOAC represents a new paradigm in multidisciplinary, collaborative research in which all sectors of the drug development enterprise collaborate in an effort to accelerate progress in developing treatment for progressive MS.
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Supported by: National Multiple Sclerosis Society.
Category - MS and Related Diseases: Clinical Science
Wednesday, March 20, 2013 4:00 PM
Moderated Platform Session S31: Multiple Sclerosis: Novel Treatments |
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