Controlled Trials in MS Rehabilitation: Theory and Design.

Clinical research, of any kind, in many ways is more difficult than bench or laboratory research. First, institutional review boards (IRBs) are increasingly restricting, controlling and overseeing the type of research done with humans. Approval of a research project may take months, and even small subsequent changes in the protocol require re-submission for IRB reapproval. Second, clinical research generally evaluates clinical outcomes. These, in a disease such as MS in which clinical fluctuations are part of the disease course, require large numbers of patients over a fairly long period of time to reach a statistical outcome. Third, because of this, costs of clinical research are high. Forth, patients with MS are growing increasingly weary of participating in research and are less inclined to volunteer for studies which require them to frequently travel to a research center for ongoing evaluations. This presentation will discuss the theory, design and limitations of clinical trials in MS rehabiliation