Clinical Trials

Lisa's Experiences

As those of you who know me are already aware, I’m taking part in a clinical trial for an investigational IVIG product. This clinical trial is number three for me as a patient. I’ve also been a part of a natural history study at the NIH. Since I’ve done this several times before, I thought I would write a bit about what it is like to be in a study and on an investigational medication. Also, there are some important things to consider before even determining if it’s the right way to contribute to the patient community and body of knowledge. 

First, there are a few things that stand out to me as most different about a clinical trial. The care involved in the trial usually has a few quirks. The most annoying quirks are some of the most helpful for the trials. Isn’t that how life works out sometimes? The first among these are the tests you have to take before you're approved for the study. Sometimes, this is a blood test. Or 17 vials of blood for blood tests. Sometimes, it is particular imaging, like an XRay or CT Scan to prove you don’t have an exclusion criterion. That can take a good chunk of time to get set, especially if these services have to be done in particular ways by particular clinics. It is meant to help control for factors outside the purview of the study - but it can seem like just more annoyance. 

Next, there is usually some homework. For some studies, like the NIH, it means collecting volume upon volume of medical records. Fortunately, they do the heavy lifting on that. For the other clinical trials, I usually have to document my infections, how I’m feeling, etc. This process usually involves taking a diary of some kind and sometimes follow-up phone calls. It’s never been anything huge or involved for the clinical trials I’ve been in, probably because I’ve only ever been in phase 3 trials that are just testing the drug over a population. 

In my experience, my clinicians follow me more closely when I am in a trial, but the overall quality of my care has been unchanged. They do like to make sure they can pinpoint any issues with the drug, especially when they’re as critical as immunoglobulin replacement therapy. It has, however, made me much more attuned to my medical care, how I react to products, and how I feel in a more generalized way. I am much better able to explain how I feel and articulate that with my providers. It’s been a big win for me in that way. 

It’s an interesting paradigm to be in, where you’re acutely aware of what is going on with your body, but somewhat less aware of your medication. I’m sure my providers would share more information with me if I asked, but part of me likes not to know, to ensure I’m honest about my symptoms and not experiencing something just because I know it is common. I often wonder about that when I read about medication side effects. What did the doctors in the clinical trial do/say for patients? Are those things more common with this drug versus another? From what I’ve learned through my own experiences, the clinical teams report absolutely everything to the FDA and the drug company to ensure that patient care is preserved and/or improved on the new treatments. Many of those side effects? They’re not more common than with others who have the illness, they’re just above the reportable threshold for the FDA, meaning that the sometimes-contradictory side effects are not much more common than in people not on those medications. 

I believe wholeheartedly that every patient, especially those with rare diseases, should engage with studies as they can. It doesn’t necessarily change your care all that much, but can make a world of difference for the patients who follow.

Have you participated in a clinical trial? What was your experience with the process?