Clinical trials. When you hear or read those two words, what comes to mind? Does it make you nervous? For many in the inflammatory bowel disease community, clinical trials can be daunting. Clinical trials are research studies involving volunteers to test a new treatment option, such as a drug or medical device. If it weren’t for clinical trials, we wouldn’t have access to new treatment options. The biologic drugs many of us depend on, are available because of the people who participated in the studies to get them approved.
You can think of clinical studies as gateway to new hope. New understanding. A bright future for all of us. Before a clinical study even happens, drugs first have to be discovered, purified, detailed and tested in labs. The tests can be tailored to your disease pattern and needs. You can think of it as taking health care into your own hands. Lilly Stairs, a fellow IBD warrior, is the head of Patient Advocacy at Clara Health. Clara Health is focused on empowering patients to find the right clinical trial. Lilly is passionate about the cause because it hits so close to home for her.
“Clinical trials are the lifeblood of medical innovation. If it weren’t for the patients who participated in clinical trials, I wouldn’t have access to the life-saving medication that has put me in remission from my autoimmune diseases. That’s why I am dedicated to raising awareness about the power of breakthrough research. Clinical trials offer promise and hope for patients now and in the future,” said Lilly.
When it comes to finding the right clinical trial, it can be overwhelming. Brandon Pomish was blindsided by a perianal disease in November 2014 and subsequently given a Crohn’s diagnosis in November 2014. In the past three years, Brandon has been put under general anesthesia 20 times and undergone eight surgeries related to perianal abscesses, fistulas and fissures. Despite getting an ostomy and taking Remicade and Imuran, nothing seemed to be helping heal the fistulas. In 2016, he decided to take matters into his own hands and research options across the globe.
“I knew there were different clinical trials and therapy options going on around the world, so I got on the computer and looked for specific clinical trials geared towards healing and curing complex perianal fistulas. A trial in Madrid, Spain, involving a pioneering stem cell procedure with a reputable hospital organization, research team, and most importantly results peaked my interest. I reached out to the authors of the study and after exchanging information and weighing the pros and cons, we decided to move forward.”
In September 2016, Brandon and his parents flew to Spain, where he underwent a liposuction procedure to collect five million stem cells. Two hours after the liposuction took place, the stem cells were injected directly into the fistulas. Brandon went back to Spain for another stem cell injection in April 2017.
While he has back in the States recovering, Brandon started to bleed during his Remicade infusion. He now also qualified for a clinical trial at Mayo Clinic involving simple (vs. complex) fistulas which he previously disqualified for because of his complex fistula status. He was told a skin graft would be removed and then inserted into the fistula site. Brandon woke up from surgery and was told that when the surgeon probed the fistula, it activated the stem cells that were injected in Spain and completely healed the fistula.
By taking a chance, doing his research and educating himself on the studies available to IBD patients, Brandon completely changed the course of his patient journey.
“If you’re desperate and your current treatment doesn’t seem to be improving your quality of life, you need to be proactive. Nobody knows your body like you do. You own your path to wellness and health. You reach a point where you are sick of suffering and Crohn’s begins to consume your life. Do your research, some clinical trials have higher risk, higher reward…others have lower risk, lower reward. Be your own best advocate. Be savvy, understand your condition and know what your options for treatment are,” said Brandon.
Brandon is currently at home recovering from a recent ileostomy reversal surgery that was made possible by this study. He is recovering wonderfully, and is excited to mentor people in similar situations.
Oftentimes, like in Brandon’s case, the benefits far outweigh the risks. As a patient you may hear clinical trials are costly, while oftentimes they are no cost to the participant. Since Brandon chose to receive his care in Europe, he was responsible for everything out of pocket, but this is typically not the case. Some may say patients have a negative experience, when in all actuality, the majority of volunteers, would sign up again in a heartbeat. When you’re part of a clinical trial, you are managed much more closely than when you’re receiving typical care. For those who feel they’ve exhausted all options and have nowhere to turn, clinical trials offer hope and answers. If you’re not responding well to treatment, clinical trials enable you to give something else a shot. And the best part of all, clinical trials allow us as patients to contribute to research and get closer to a cure.
“It is essential that as members of the IBD community we champion the power of research and educate fellow patients about clinical trials. Together we can empower patients with the knowledge that clinical trials are a treatment option and accelerate the pathway to breakthrough treatments and cures,” Lilly added.
Interested in getting started? You want to determine what kind of trial you want. From types of studies, to treatment methods, to trial phases, there are a multitude of components that need to be taken into consideration. Next, you need to make sure you qualify for the study. For instance, if the study is looking for people who have never tried a biologic and you have been on Humira for years, that particular study wouldn’t be a good fit for you. Clara Health holds your proverbial hand throughout the whole process, whether it’s communicating with your physician or touching base with researchers. They have a specific landing page on their website that identifies clinical trials for Crohn’s disease. The list offers up countless opportunities that could transform the way you take on your disease.
Rather than thinking of clinical trials as a last resort, we as IBD patients need to change our perception. Without clinical trials, we won’t get new and better treatments. Click here to check out clinical trial information from the Crohn’s and Colitis Foundation. We need to change our mindset and focus on the importance of using our stories and our journeys to gain a better understanding of IBD. Instead of worrying about the risks, think about the all the possibilities.