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.
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.
Here we provide information on several types of studies that are of interest to people affected by MS. These lists are just a sample of what appears on clinicaltrials.gov, to give people affected by MS an idea of the latest clinical research in MS. These are studies that are ongoing, or recently completed.