Multiple Sclerosis Consortium Sets Up MS Clinical Trial Database of Patient Records for Research Use
The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) is making available to qualified researchers a new database containing almost 2,500 records of patients who were part of the placebo groups of nine multiple sclerosis (MS) studies.
The MSOAC is a large-scale partnership, launched by the National MS Society and Critical Path Institute (C-Path), to develop new standards for assessing outcomes in clinical trials of MS therapies. The MSOAC collects, standardizes, and analyzes data from MS studies with the goal of developing more sensitive ways of determining the benefit of treatments that might slow or reverse progressive disability in patients.
“Key to the success of every C-Path consortium is the sharing of expertise and data,” Lynn Hudson, PhD, C-Path’s chief science officer and executive director of MSOAC, said in a press release. “The sharing of both treatment and placebo arm data by MSOAC member companies is unparalleled.”
Approximately 15,000 records from active treatment and inactive placebo arms are being evaluated for inclusion in a new tool being developed to measure MS disability and progression in scientific studies. The tool, which will also integrate MS patient perspectives, will be submitted for regulatory qualification to the European Medicines Agency (EMA) and to the U.S. Food and Drug Administration (FDA), a necessary step to its being validated for use as a primary outcome measure in clinical trials.
“We’re pleased to enable investigators around the world to access previously unavailable data through the new placebo data platform, which should increase our understanding of MS,” said Bruce Bebo, PhD, executive vice president for research at the National MS Society. “MSOAC is the latest in a long line of special initiatives undertaken by the Society to enhance the conduct of MS clinical trials and thereby speed the development of new therapies for all forms of MS. By bringing multiple stakeholders to the table, including people with MS, we have been able to achieve broad support for our goal of better and faster trials.”
Standardization is essential to the quality of pooled data. The MSOAC started by creating another tool — a data standard for MS — in collaboration with the Clinical Data Interchange Standards Consortium (CDISC), a global, multidisciplinary, and non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.
The MS data standard was also created to assist drug developments in meeting new FDA requirements, starting in 2017, to implement CDISC data standards in their submissions.
The MS data is stored at The Data Collaboration Center (DCC) of C-Path, founded to offer large-scale data solutions for scientific research. To date, the DCC’s program hosts data from 83 trials involving more than 49,000 participants, over 100 million data points, and six distinct therapeutic areas.
A professional review panel will assess requests from researchers for access to the MS placebo arm database, using standards similar to those used in requests to use C-Path’s placebo database for Alzheimer’s disease.