A new data standard for multiple sclerosis has been released by the Clinical Data Interchange Standards Consortium.
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.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.