Participate in a Clinical Trial
Interested in a local clinical trial? Under "Topics" in the left-hand margin, filter by your state and/or type of MS.
Benefits and Risks of Participating in Clinical Trials
Clinical Trial Basics
- Phase I determines safety and dose. In a small number of healthy volunteers or persons with MS, the investigators:
- Determine the safe doses
- Identify safety concerns
- Understand side effects of the drug
- Phase II determines the effectiveness of the therapy in people with MS. A phase II study may last several months or years. It involves larger numbers of people to further evaluate safety. The study is controlled — that is, the therapy is compared with the standard treatment or an inactive placebo. Studies in this phase are meant to determine if a phase III trial is worth the large investment of funds that would be required.
- Phase III suggests effectiveness and safety. An even larger study is conducted in hundreds or thousands of people to definitively determine the therapy’s effectiveness and to gain a better understanding of the therapy’s possible side effects. These multi-center studies can span several years and several countries.
- Also called “post marketing studies,” Phase IV might be conducted following FDA approval. It assesses long-term safety and effectiveness.
Participants Are Protected
How To Participate in MS Clinical Studies
- People who wish to enroll in clinical trials are generally required to meet the following requirements:
- Reside close to the research facility (usually within 150 miles)
- Have the specific diagnosis that is under study
- Meet the study’s guidelines relating to age, sex, level of disability and duration of disease
- Be able to understand the possible risks of participating and to give consent, and be able and willing to follow study instructions
- Additional requirements unique to each study
placebo response? - Who else will know that I am participating in this study?
- What kinds of tests and treatments are involved?
- How often will I have to come to the study site?
- How might this trial affect my daily life?
- How long will the trial last?
- Who will pay for the experimental treatment or tests?
- Will I be reimbursed for other expenses such as mileage, parking or meals?
- What type of long-term, follow-up care is involved with this study?
- How will I know if the experimental treatment is working? Will the results of the trial be provided to me?
- If the treatment works, can I continue receiving it?
Below are some key questions to ask if you’re considering a clinical trial.Study Overview
- What is the purpose of the study?
- Why do researchers believe this new treatment might be effective?
- Has the treatment been tested before?
- How many people have been exposed to the treatment?
- What are the side effects and risks of the treatment under study?
- How do the possible risks, side effects and benefits of the study compare with my current treatment?
- Does this study use a placebo, inactive substance or “sugar pill” to compare results with those of the drug under study or another treatment already on the market? If so, what are the chances that I will receive a placebo? What is a placebo response?
- Who else will know that I am participating in this study?
- What kinds of tests and treatments are involved?
- How often will I have to come to the study site?
- How might this trial affect my daily life?
- How long will the trial last?
- Who will pay for the experimental treatment or tests?
- Will I be reimbursed for other expenses such as mileage, parking or meals?
- What type of long-term, follow-up care is involved with this study?
- How will I know if the experimental treatment is working? Will the results of the trial be provided to me?
- If the treatment works, can I continue receiving it?
Well-designed clinical trials should be “controlled” in a way that the expectations of the participants and the researchers do not bias the trial outcomes or interpretation of those outcomes. In most controlled studies, 1 or more groups of participants — the treatment or experimental groups — receive the treatment being tested, and the other group — the control group — receives a previously approved treatment or an inactive placebo.Often both the participants and the researchers are “blinded,” meaning neither knows which treatment any individual is taking until the trial is over and the data has been analyzed. Special circumstances, such as illness or unintended pregnancy, may allow the treatment to be revealed before the trial has ended. In this case, the individual would not be able to continue in the trial.If you are considering becoming involved in a study in which the experimental therapy is being compared to an inactive placebo, make sure that you compare your treatment options with therapies already on the market. Then, learn what the probability is that you will receive an inactive placebo.
Your agreement to participate in any study must be based upon a process known as “informed consent.” This requires the study coordinator or investigator to thoroughly explain the clinical trial, including:
- The risks and benefits of the study therapy
- The study schedule
- Tests or procedure to be done before and during the trial
- Your responsibilities during the trial
- The study staff responsibilities
- Alternative treatments
- Your rights as a study volunteer and who you can call if there are any problems or questions
Before participating in a clinical trial, discuss the study with your doctor. If you decide to participate, put your doctor in touch with the doctor running the study. Give your doctor permission to share medical information to ensure your safety during a clinical trial.Even if your own doctor is running the study, be sure to tell the doctor or the study coordinator if you are taking medication for a condition other than your MS. Even a routine treatment for an unrelated condition might accidentally interfere with the study’s results, or even be harmful to you.
Understand who is covering the costs of the study. The consent form should outline any costs that will be billed to you or to your insurance. In most cases, the research team covers the cost of the study therapy and any medical care performed to fulfill the study’s goals. Contact your health insurer — with the protocol or consent form in hand — to find out whether treatment for any side effects or routine care will be covered so you understand what you might be expected to pay.