Treatments for relapsing-remitting Multiple Sclerosis (RMS) have been available commercially since 1993—and since that time, patients have developed an increasingly sophisticated and accurate understanding of RMS. While this is obviously good news for individual patients, it poses certain challenges for researchers attempting to develop and evaluate new and more effective treatments for RMS; for interventional MS research, and in particular, RMS research, traditional clinical endpoints for a study may not be sensitive enough to demonstrate that a new drug is more effective than an existing standard treatment, particularly in earlier phase exploratory research characterized by limited sample sizes, and demands for efficient exploration of dose, exposure, and response. In addition, in an RMS research population with low disease activity, it's difficult to detect differences with respect to placebo, given similar constraints.
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