Clinical Trials

I often get asked the question: “Should I participate in this clinical trial on …?”  This is always a difficult question to answer because there are so many things to consider when making that decision. In order to know how to make a decision about whether or not to participate in a clinical trial, it is helpful to first understand what a clinical trial is and what the purpose is of a clinical trial.

Clinical trials are used to determine if a given intervention or medical device is safe and effective for a particular group of people.  To this end, a clinical trial is carefully designed to answer a specific question, in a clearly defined group of people. For instance, a clinical trial may evaluate the safety and effectiveness of a certain exercise program (intervention) for people with MS who are still walking. 

An intervention can include not only a behavioral treatment, such as exercise, but it can also involve the use of biological products (like stem cells), drugs (such as a given disease modifying drug), and devices (e.g., muscle stimulator).

Some clinical trials don’t involve an intervention, but are designed to evaluate the way that care is delivered, or the timing at which care is delivered.  Sometimes, what is being studied is not yet being done in the clinic, or is being done for another patient population.  For instance, electrical stimulation to muscles combined with cycling is being provided to people with spinal cord injury, but not routinely for people with MS.  A clinical trial might then be designed to evaluate the safety and effectiveness of this intervention in people with MS.

One very important thing to remember is that a clinical trial is not clinical care.  A clinical trial is a research study, to answer a question to which we do not yet know the answer.  So, a clinical trial that is evaluating the health-related response to an intense exercise program in people with moderate to severe MS is not treatment.  In fact, there are a number of outcomes that can come from this study:

1. the people who participate in the exercise program can get better in the outcomes measured when compared to those who do not get the exercise program;
   
2. the people who participate in the exercise program can get worse than those who do not , or experience a negative effect;
   
3. there is no change in the people who participate in the exercise program compared to those who do not participate in the program; or
4. there may be side effects of the intervention that have not yet been discovered.  Since the intervention or device may not have been shown to be safe or effective for someone like yourself yet, and there is no guarantee that you will benefit from it.  Thus, participating in a clinical trial has some risk associated with it, and needs to be carefully considered.

Another important consideration is that a clinical trial generally involves a “control” group – a group that does not receive the intervention.  When you enroll in a clinical trial, you will be randomly assigned to either the intervention group (as in you will receive the intervention), or the control group (you will not receive the intervention).  Typically, this means that you will go through the same tests that those in the intervention group go through, but you will not receive treatment.  You also may not be able to participate in other clinical trials or receive other treatments that might make it difficult to interpret the results of the trial. 

Deciding whether or not to participate in a clinical trial depends on your situation, your needs, and your views.  There are several positives to being in a clinical trial.  When you are involved in a clinical trial you gain a better understanding of your condition, of the treatments available, and of the research process.  All of these help you to be a more informed consumer, and allow you to have an active role in your care.  You may get access to an intervention that is not yet available clinically, and you can do so while being monitored for safety.  Also, what is learned from the trial may help other people like you in the future.  For instance, if you have minimal disability due to your MS and you participate in a trial that shows that running will not cause a relapse or any negative effects, but will keep your healthier and more functional longer, this will tell people like you that they may also exercise to maintain greater health and function.

There are many clinical trials underway in MS.  We are making much headway in terms of medical treatments, as well as rehabilitation and exercise.  Being in a clinical trial will allow you to be a part of advancing MS care.  Only you can make the decision about whether or not you should participate in a clinical trial. The first step is being an informed consumer.  Stay tuned for the next blog where I will tell you about the different phases of a clinical trial in the United States.

In the meantime, here are some questions you can ask when making your decision about being in a clinical trial.  Never be afraid to ask your questions – this is your right to know.

Ask the researcher:

• What is the intervention?
• How often do I need to come to the lab/clinic?
• How is the intervention delivered?
• Are there any risks?  If yes, what are they?
• What do I need to change if I am in the study? Do I need to stop any other treatment or exercise programs?  Do I need to change my medications?
• Who are the people performing the tests and delivering the intervention?  Are they trained to do these?
• Can I participate in other interventions or studies if I am in this study?
• What happens if I am injured or become ill during this study?
• Will you provide medical care if I am hurt due to the intervention?
• How much time will this study take?
• What happens if I miss a session?
• Can I stop the trial at any time and will this affect my other care?
• And anything else that you feel you need to know before you participate

Check with your insurance carrier:

• Will being involved in this study change my health or medical benefits now or in the future?

Other resources (these are also listed on our "News and Events" page, so you can easily access these sites at any time from this website):
http://www.nationalmssociety.org/Research/Research-We-Fund
http://clinicaltrials.gov/info/resources
http://www.centerwatch.com/clinical-trials/overview.aspx