Clinical trials are important – scratch that … clinical trials are essential to make advances in disease treatments. We have trials to prove efficacy and gain FDA approval for the sale of drugs in the US. The only way to get those trials done is to find people to participate in those trials. A new treatment can be studied over and over on animals in a lab, but we aren’t mice, and until people are tested we don’t know for sure if something works on us two-legged animals or not.
You would think that would be easy – we all want to find a cure for MS or at least ways to make living with it easier. We are all willing to help, right? So why do we hear that it is a struggle to get participants in these essential studies.
There are many factors that might keep us from doing our part – the first and most obvious one would be we might not fit the criteria for the study. Because MS is known as a young person’s disease, the majority of the studies for the disease modifying therapies (DMT’s) have age limits – I was diagnosed at the age of 54 and was already too old to participate with any of those DMT studies my neurologist discussed. What works best for newly diagnosed person with RRMS needs to be studied within the age range of 20-50, or so.
We might be willing to help, but maybe we don’t meet other criteria – each study is very specific in what the person with MS needs to qualify. Perhaps it is looking for people who are treatment naïve, meaning they have not been on any DMT to that point. Or it could be a study of a drug that wants to show switching to this different therapy works, but requires finding people willing to make that switch.
Besides DMT trials, there are many other studies - some that look at new drugs or others that study behaviors and ways to improve our lives. I have been able to participate in a few of those and come away with a greater appreciation for anyone who helps with trials and studies. My favorite has been imaging studies where I have had multiple high-strength 7T MRI’s done as part of a researcher’s investigation into grey and white matter lesions. That one was fairly simple – travel to their facility, and take a long nap (yes, I sleep during my MRI’s) while they take a deeper look. But most studies aren’t quite that quick and easy.
I am currently in a trial for an extended release form of Baclofen – instead of taking Baclofen four times a day, this new formulation would allow me to take just one pill a day. I am all in favor of the ‘less is more’ attitude and if I can cut out extra pills, count me in. Last summer when my neurologist asked if I might be interested, I was game to help. What could be so difficult about taking pills and checking in with them regularly? My answer would be a lot –there is a time, inconvenience and expense involved in helping with this study.
There is a small stipend offered to help the participant with the cost, but as I compute it, I am still paying to investigate this drug. Each visit to their office – I am estimating there is a total of 15-20 in all for the duration of this study – requires me to drive the 90 minutes to their office, using a lot of gas and time. I try to coordinate these checkups with my monthly Tysabri infusions, but that isn’t always possible because there are some stretches where I am asked to come for weekly check-ins.
Fortunately I still work, and consequently each time I travel for this study check-in, I am using more of my sick/vacation leave time from my job. My employer has generous benefits but this is still time I could be using for something far more enjoyable. Essentially I am donating my work benefits to participate in this drug study. When I run the numbers, it appears I am subsidizing about 50% of the cost to help with this study. It should also be noted I have yet to see any reimbursement for these expenses, after 7 months of being in this study, so you can't do this if you are thinking the money will come in quickly to help cover costs.
One benefit of this study is I do get the drug at no cost to me, but baclofen is already very affordable through my insurance and only costs $50 for a three-month supply. Is this money savings enough to justify helping with this trial? Not really.
So why do trials? I’ve explained the personal costs to the participants and the inconvenience, but I am still glad to be a part of this study. The only way we will make advances in treatment for Multiple Sclerosis or any other diseases is through these trials – and for me it is just one small way I can contribute.
Do you have experience with a clinical trial or study?
The next time you hear of a trial recruiting participants, be sure you understand the costs involved to participate, but also remember how much good you can do by offering yourself. Until mice evolve to walk on two legs, human participants are still the key to improving treatments for all of us.
Wishing you well,
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