– New tools to speed pace of MS clinical trials being evaluated by drug agencies
- In a large pooled evaluation of clinical trial data from 14 MS drug trials involving 12,776 people with MS, four clinical measurement tools that detect changes in walking, vision, cognition and manual dexterity were verified as being able to evaluate meaningful changes in disability in clinical studies.
- The study was undertaken by members of a National MS Society-supported international collaboration MS Outcome Assessments Consortium (MSOAC) as part of its ongoing efforts to provide evidence to convince the U.S. Food and Drug Administration and the European Medicines Agency that these tools can provide a more meaningful assessment of disability than current measures and thereby speed the pace of MS clinical trials.
- Together, the four measures provide snapshots of how an individual’s physical and mental functions may remain stable or change over time, and this latest study suggests their use will improve the ability to detect benefits of therapies in clinical trials.
- The new paper was published in Neurology online on October 22, 2019 and its full content may be read by anyone free of charge.
The international MS Outcome Assessments Consortium
(MSOAC) was launched after a National MS Society-supported task force met in late 2011 to determine how to address the need for better measures of MS-related disability in clinical trials. It became clear that collaborating with the Critical Path Institute
(C-Path) would create a clearer path forward. C-Path is a nonprofit partnership with the FDA, 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 therapies.
Participants in MSOAC include representatives from academic institutions, pharmaceutical companies, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the National Institutes of Health, and people living with MS. Over the multi-year, $3 million project, MSOAC conducted literature reviews and gained perspectives of people with MS, along with data from clinical trials, to assess measures that could be used to detect and evaluate the disability status of individuals with MS in terms of walking, vision, cognition and manual dexterity.
Five previous journal papers
have been published that review published evidence for the validity of the four measures and the extent to which they can detect changes that are “clinically meaningful” (reflecting functions that may impact an individual’s activities of daily living).
: Another key activity has been to collect data from MS clinical trials, then standardize and analyze the data to identify the optimal measures for inclusion in a proposed outcome measures tool. This effort involved one of the largest pooled evaluations of clinical trial data in MS to date, involving 14 MS drug trials with 12,776 participants with MS. Based on this combined trial data, the MSOAC team has published a paper in Neurology
(Online October 22, 2019
) that validates the four measures, used alone or in combination, as sensitive clinical outcome measures for MS clinical trials. The paper and its full content may be read by anyone free of charge.
The four clinical measurement tools validated in the paper detect changes in walking (timed 25-foot walk), vision (low-contrast letter acuity), cognition (Symbol Digit Modalities Test) and manual dexterity (Nine-Hole Peg Test).
MSOAC has submitted applications to the FDA and EMA for regulatory approval of the measures. Upon qualification of the tool set for use as a primary outcome measure in clinical trials, it will be made freely available to investigators.
Read more about MSOAC