22 - Ethical considerations in multiple sclerosis clinical trials

Summary

The imperative to develop more effective medication for multiple sclerosis (MS) persists. In view of the availability of several partially effective immunomodulatory drugs for the treatment of MS, the National MS society (NMSS) convened an international task force to deliberate the continued use of placebo-controlled trials. Clearly, patients should not be deprived of the opportunity to participate in a placebo-controlled trial if they do not wish to use approved therapies. The ethical issues and practical limitations governing placebo controlled trials remain complex. Clinical trialists clearly have a mandate to include ethical considerations in all aspects of the design, implementation, and conduct of clinical trials. The continued use of placebo controlled randomized clinical trials in an era of partially effective therapy remains controversial. Both the utility and ethical conduction of placebo-controlled trials in MS are likely to continue to evolve as the MS therapeutic armamentarium grows increasingly refined.