The interferon-beta 1b clinical trial and its implications for other trials.

Abstract

This trial was monitored by both clinical and magnetic resonance imaging (MRI) methods. Clinical effect was a 30% reduction in relapse rate in the group treated with a high dose. The MRI activity rate was reduced by a median of 70% in both treatment groups. The burden of disease measure showed a clear-cut dose effect in the 2-year analysis. Future trials must be monitored by MRI. In addition, placebo controls will continue to be necessary in most trials, especially if long-term effects are to be measured.