Multiple Sclerosis Research Repository

1. “Guideline on clinical investigation of medicinal products for the treatment of Multiple Sclerosis: Draft”: European Medicines Agency (20 September 2012) (Committee for Medicinal Products for Human Use)

-”Some of the currently approved therapies have demonstrated a favourable effect on the rate and severity of relapses as well as an effect on short-term (a few years) progression of disability.  However, it remains surprisingly difficult to relate relapses prevention to prevention of disability.  Therefore a claim of an effect on disability can not be claimed when not evaluated separately”

-”…relapse rate…cannot be taken as a surrogate for disease progression…”

-”It would be highly desirable also to evaluate if the effect on progression is maintained on a long-term basis”