A new data standard for multiple sclerosis (MS) has been released by the Clinical Data Interchange Standards Consortium (CDISC), the leading global standards organization for clinical research. When used together with the foundational CDISC clinical data standard, this therapeutic area standard allows clinical research data from multiple MS trials to be grouped for reporting, analysis, and regulatory submissions.
The standard is the result of work from organizations across the globe. Led by the Multiple Sclerosis Outcome Assessments Consortium (MSOAC), a Critical Path Institute (C-Path) consortium, the effort drew on the ‘common data elements’ developed for MS through the National Institute of Neurological Disorders and Stroke (NINDS). MSOAC members with clinical expertise in MS connected with CDISC teams in the standardization process designed by the Coalition for Accelerating Standards and Therapies (CFAST) initiative. In the CFAST standardization process, standards developers work closely with clinical experts on definitions and scoping from the beginning.
Like other open CDISC data standards, the new MS standard is freely available (http://www.cdisc.org/therapeutic#MS). “This new tool is more than another resource for the MS research community, ” indicated Dr. Timothy Coetzee, Chief Advocacy, Services and Research Officer at the National MS Society. “This new MS standard signals a commitment to ensure that data does not remain in silos. By standardizing data we expect that research will move us faster toward our goal of a world free of MS.”
Read the full release here.