Clinical trials help to determine if a drug is safe and effective for people with MS. People with MS who are willing to volunteer in these studies make it possible for all of us to look forward to new and better therapies.
Clinical Trial Basics
The process is complicated. Many factors are involved in making sure that a study is conducted properly and that the results are valid. The U.S. Food and Drug Administration requires therapies to undergo three phases of clinical trials before they can be approved to treat people with MS:
- Phase I – The first step is to determine safety. In a small number of healthy volunteers or persons with MS, the investigators determine how the human body reacts to the therapy.
- Phase II – If the therapy proves to be safe, studies begin to determine the effectiveness of the drug in people with MS. These studies may last several months or several years, and involve larger numbers of people. The study is "controlled"—that is, the drug is compared with the standard treatment, or an inactive placebo.
- Phase III – If an MS drug shows effectiveness, an even larger study is conducted in hundreds of people to gain a better understanding of the drug’s effectiveness and possible side effects. These multi-center studies can span several years and several countries.
Following FDA approval, post-marketing studies (phase IV) might be conducted to assess long-term safety and effectiveness.
Participate in Clinical Trials
People with MS can take an active role in freeing the world of MS by participating in drug studies. Find out about local studies and what you need to know before you participate.
Clinical Trial FAQs
What you need to know before you participate.
Clinical Trials in MS 2009 (.pdf)
There are now 129 ongoing, planned, or recently completed clinical trials in multiple sclerosis, according to Clinical Trials in MS 2009 (.pdf), a list compiled by the National MS Society. These studies are bringing new hope for oral drugs, better options for people with progressive MS, and novel approaches to alleviating symptoms. For recent results of MS research, including clinical trials, see Research News.
Glossary of Clinical Trial Terms
Some terms commonly used related to clinical studies.
Additional Clinical Trial Resources
More listings of ongoing MS studies and general information on participation in clinical research.
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