EMA: Concept paper on the need for revision of guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis
New treatment options e.g. immunosuppressants prompt to reconsideration of treatment targets, target population, trial design, choice of endpoints, among others. In the dawn of treatments intended to improve residual impairment, the design of clinical trials for specific symptomatic improvement needs discussion. In addition, the current guidance lacks recommendations with respect to data needed in the paediatric population.
The source of the news: http://files.pharma.info.pl/wpliku/emachmpcnswp2575652011.pdf