Is an MS Clinical Trial for You?
MSer Libby Selinsky shares her experiences with clinical trials — one in 2008 and the other in 2016.
“You are lucky to be getting MS now.”
Those are the most annoying words my neurologist has ever said to me. After some time I was able to dial back my guttural reaction and realize my chances of thriving with this disease are incredibly high, simply because I have it now, when science is making incredible strides.
If you want to take part in a clinical trial, it is important to remember to weigh out the pros and cons for yourself and the way that they will affect your life.
Phases of Clinical Trials
Clinical trials go through three phases before the medicine that the scientists are testing is reviewed and approved by the FDA:
- Phase I: Researchers test a new MS medication or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
- Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
Health risks must be looked at seriously. If you are in great health and your progression is moving slowly, then a phase I or phase II trial might not be the best thing for you to try. The earlier phases can pose a higher negative risk to your health than the positive benefits you might receive.
Phase III and IV studies are more stable and a lot less risky. However, if you are further along in your disease progression or if you have the primary progressive form of MS, then you might find a phase I or II trial could suit your needs better.
The important thing to remember is many of these trials can carry serious or even fatal side effects. Think deeply about how much you are willing to risk and compare it to what you might gain before taking that first step.
Once you have found a clinical trial that interests you, it is time to reach out to the researchers who are running it. All of the clinical trials I have been a part of have been run out of my neurologist’s office — it is a good probability that your neurologist is running clinical trials too.
In any case, the trial researchers will take the time to screen you to see if you are a strong and eligible candidate for their study. This is a process that can easily be taken personally. It is hard to get emotionally ramped up for a study only to find out that you have been denied because of some strange caveat.
The reasons for being ineligible may seem arbitrary, but they are just the scientific parameters that have been placed on the study in order to ensure a consistent and replicable result. The reasoning has nothing to do with you personally — and this leads me to my next point: you are going to become a number.
What to Expect
You will find your appointments within the trial will be much more clinical and your tests and results will not belong to you. Oftentimes you will not know the results of many of the tests they run.
For example, I was on the fingolimod (Gilyena) phase III trial. My body was run through the full gamut of tests, during which I had to go through several MRIs to check for disease progression, and I was not privy to the results!
However, you basically get free medical treatments during the study. MS is an expensive disease — clinical trials will often run thorough tests that go above and beyond what your normal neurology visit or even annual physical will do.
I had to get a full body checkup during my screening for the fingolimod trial. It was important that everything in my body was cleared as healthy so I could be deemed an acceptable candidate for the phase III trial.
I was never allowed to see the exact numbers for these screening results; however, if they had found anything of concern I would not have been permitted to move forward. I loved going through all of these tests because it was a free, in depth, full-body health assessment.]
Fingolimod was a great trial for many people to be a part of. I was a part of the trial during the year of 2008, when there were zero disease modification treatments on the market that could be taken orally. For many people, the fingolimod trial was a great way of getting their hands on the newest treatment, which was orally administered, and for free!
Next page: Libby discusses her most recent experience with an MS clinical trial.