Improving clinical trial designs in MS
Study suggests that longer observation time is necessary for more reliable results
Last updated: 4th December 2015
Currently, the most important goal of MS disease modifying therapy is to prevent permanent disability.
Assessing disability outcomes in MS in clinical trials is a complex task. Most trials rely on a change in the Expanded Disability Status Scale (EDSS) score, observed over 3 or 6 months. The EDSS is a scale that takes several neurological functions into account (such as visual and motor functions) and assigns a score to each of them. When added up, this results in a final unique disability score.
In relapsing-remitting MS, accumulation of permanent disability is often obscured by short-lived neurological impairment caused by relapses. Therefore, delayed confirmation of newly acquired disability after a relapse is essential to distinguish irreversible progression from reversible disability associated with relapses.
A team of experts from Europe, America and Australia conducted an observational study on a very large group of people and suggested that longer disability confirmation periods, like 12 or 24 months, in the design of observational studies and some clinical trials, provide a more accurate evaluation of the disability progression in people with relapsing-remitting MS.
This study reemphasises the challenge of designing clinical trials in MS and confirms that, in some cases, longer observation is necessary for more reliable results.
Read the full article (external website opens in a new window)