IBD Patients are the Key to the Cure
Have you ever stopped and thought for a moment about the aspirin you take for pain? No? Neither have I. But at one point, even aspirin, was tested through clinical trial research. As a society, we have a tendency to take these over the counter drugs for granted. We don’t stop to think about when and where they came from, simply because we can’t remember a time when they weren’t available. Because of their reliable reputations, we often use them without extra consideration. Perhaps you skim through the ingredients or listed side-effects but for the most part we trust that the medication will react as anticipated.
The same can be applied to the antibiotics our community so frequently uses, as well as other medication and biologics used to treat our disease. We take these because we *trust* that our doctor is looking out for our best interest. I’m sure that many of us, including myself, have hesitated before starting a new IBD medication because of the side effects and the fear of the unknown. However, we ultimately end up taking it because we have the hope that it will improve the quality of our lives. The level of uncertainty and fear of the unknown when undergoing a clinical trial is similar, if not the same. The main difference is some years and layers of testing between them.
This means that you, as an IBD patient, could hold the key to curing this isolating and debilitating disease. In the chronic illness community, and those with IBD especially, there are a lot of patients who hesitate to stray from “what works now” in fear of losing out on options. However, with this preconceived notion, and without active transparency and participation in clinical trials and research, the future options become less and less. As an IBD patient and advocate, I understand how crucial patients are to developing future IBD medications. However, in a world where people have come to expect -- or even require -- fast results, clinical trials may not seem like a viable option to everyone. So let’s explore some of the pros and cons to participating in a clinical trial.
What’s a Clinical Trial and How Do I Participate?
A clinical trial is research intended to advance medical knowledge. In a clinical trial, voluntary participants receive specific interventions or protocols outlined by the researcher. These interventions include drugs, devices, procedures, or changes to the participant’s behavior. Clinical trials are intended to determine the safety and efficacy of an intervention.
Clinical trials have requirements for their participants (i.e. age, gender, type and stage of disease, previous treatments, other medical conditions, etc.). The first step to participating in a clinical trial is determining whether you’re eligible or not.
If you are eligible to participate in a clinical trial, be sure to discuss with your doctors. Here are some questions to consider:
What is being studied?
Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
What are the possible interventions that I might receive during the trial?
How will it be determined which interventions I receive (for example, by chance)?
Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?
How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
What will I have to do?
What tests and procedures are involved?
How often will I have to visit the hospital or clinic?
Will hospitalization be required?
How long will the study last?
Who will pay for my participation?
Will I be reimbursed for other expenses?
What type of long-term follow-up care is part of this trial?
If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
Will the results of the study be provided to me?
Who will oversee my medical care while I am participating in the trial?
What are my options if I am injured during the study
The Pro’s to Participating in a Clinical Trial
Participating in a clinical trial can be a very powerful and positive experience. Our struggles can potentially help shape new treatment in the future! While pursuing your own medical care, you get to have a greater impact on the entire community by contributing to scientific research.
Through clinical trials, you can also gain access to new treatments that insurance would not cover - treatments that may work! Not only are you getting free medical care but often there is compensation to participate.
Barriers to Participating in a Clinical Trial
Lack of Awareness
The majority of patients are unaware that their participation in a clinical trial is an option for them.
Lack of Trust
One of the biggest concerns is in regard to double blind studies; participants fear that they may not receive effective treatment. However, it’s important to note that studies are not placebo-controlled or only enroll a small percentage of participants in the placebo group so this may not be a big concern, depending on the study.
Participating in clinical trials can sometimes mean going drug-free for a period and this could result in possible flaring. Participants also need to consider the psychological impact of not knowing whether or not it will work. They are also facing the fear of the unknown - what will be the side effects and/or risks? These can be difficult concepts to deal with.
Many patients also have safety concerns, especially when it comes to Phase I studies. Most clinical trial opportunities do not fall into this category, though.
Lack of Accessibility
For some, the biggest barrier is the time and costs associated. Participating in a trial can mean an increase in imaging (scopes, tests, flex-sigs or bloodwork) and it can be difficult to take extra time off from work or make travel arrangements. That’s not to mention the physical accessibility issues that arise. Some patients are unable to participate in a clinical study because they are bedridden or have other physical limitations.
Because of the reasons above, some would only consider if they’ve exhausted all other options and at that point they are potentially in their worst flare and very sick which would affect their ability to participate due to energy reasons.
How to Overcome These Barriers to Help Improve Patient Participation and Research
So how do we overcome these barriers? I believe the first step lies in awareness. We need to create trust within the communities by sharing our own experiences and creating that transparency. By doing this, we can combat this “fear of unknown” and works towards increasing patient participation. I’d also encourage everyone to work with your GI doctors to learn about new clinical trials that may be a viable option for you. This can also help combat the “fear of unknown” by reviewing some of the questions highlighted above.
I’m starting this dialogue in our community because I am personally passionate about the importance of clinical trials. In my own experience, with a case as complicated as mine where I ultimately “failed” all of the biologic options on the table, research is necessary.
Do you have a personal story about participating in a clinical trial? Are you in support of clinical trials? Share your story in the comments or share this post to keep the dialogue going.
Alicia was diagnosed with ulcerative colitis at the age of 14 and when she was re-diagnosed with Crohn's disease at 22, Girls With Guts was just starting out. Her passion for GWG was instantaneous as she had not had that kind of support before.
She has been on the board of Girls With Guts since 2013 starting out as Director of Multimedia, and recently became the new President. She’s always had a knack for bringing ideas to life and that is where her passion and Girls With Guts merged. If she’s not helping to coordinate the annual Girls With Guts retreat or furthering the overall vision, you can catch her raising awareness about her personal IBD journey whenever she can.