ABSTRACT
The past decade has been a remarkably produc tive period for clinical trials in multiple sclerosis (MS). Not only have there been four new thera peutic agents, representing two different classes of drugs, approved for use throughout most of the world, but there have also been many earlier phase studies of promising new agents, some of which have moved to currently ongoing pivotal studies. Some preliminary studies, as well as some larger, pivotal trials, have failed, either because they have not achieved statistically sig nificant outcomes or because the agents being tested have been proved to have unacceptable risk-benefit outcomes. Even those new agents that have been shown to be relatively safe and effective have only modest treatment benefit, and there is much need for new products, new dosing regimens of available products, and study of combinations of agents. All of this points to the ongoing importance of, and increasing attention to, randomized controlled clinical trials for new therapeutic agents in MS.
