In line with key goals of its Strategic Response to MS, a National MS Society task force is launching a far-ranging collaboration to analyze how MS is measured in clinical trials that involves a new method for measuring disability related to MS and resulting progression. The goal of finding new therapies to stop MS progression requires new or improved tools that will be able to track benefits of therapies more quickly in people, using better assessment tools that are accepted by drug regulatory agencies. The task force reports its initial progress in the MS Journal (2012;18:1074-1080
Disease progression, or gradual worsening, experienced by people who have MS usually occurs over many years, and it is often difficult to track with the standard clinical measurement scales used by doctors to assess disease activity. Based on the recommendations from a previous meeting, an international team of research advisors recommended establishing a task force to revise the MS Functional Composite (MSFC) – one measure currently used to measure MS disability.
The MSFC Task Force includes experts representing the clinical trials arena, academia, industry, regulatory agencies and patient advocacy groups. This team is shepherding the process of revising the MSFC scale for use as a primary outcome measure in MS clinical trials.
Task Force Progress:
The MSFC task force met late last year, and established its goals. Members agreed that a key aspect of the project is to analyze data that have already been collected using the current version of the MSFC during the course of the past 15-20 years, primarily from industry-sponsored pivotal clinical trials.
It became clear through discussions that a collaboration with the Critical Path Institute (C-Path) would be of great value to the goals of the project. C-Path is a nonprofit partnership with the U.S. Food and Drug Administration, whose aim is to accelerate the pace and reduce the costs of medical product development by creating new standards for evaluating the safety and effectiveness of new therapies. C-Path currently has five such collaborations including one with the Coalition Against Major Diseases, which focuses on Alzheimer’s and Parkinson’s Disease.
Following the 2011 meeting, the MSFC Task Force sought a proposal from C-Path to complete this work. This proposal involves creating a database of aggregated, clinical data, and analyzing these data in order to arrive at a consensus on the optimal components for inclusion in a modified MSFC; and then advancing a revised clinical outcome assessment drug development tool based on the MSFC to the FDA and EMA (European Medicines Agency) for regulatory approval.
“The potential partnership with C-Path will align our efforts with regulatory agencies such as the FDA and EMA,” says Nicholas LaRocca, PhD, the Society’s Vice President of Health Care Delivery and Policy Research, and a member of the MSFC Task Force. “This is critical – these agencies must approve of the measure if we are to use it in clinical trials.”
“The MSFC Task Force is making significant strides toward the effort to change how MS disability and progression is measured,” adds Chief Research Office Timothy Coetzee, PhD. “This work addresses a glaring need for a way to quickly evaluate the ability of potential therapies to stop or reverse MS progression.”
about efforts to stop MS in its tracks and restore function
to people with MS.