Overcoming 10 Barriers to Participating in Clinical Trials
There has never been a more critical time to participate in celiac disease clinical trials and studies. There are now many companies interested in developing greatly needed treatments and improved diagnostics for celiac disease. To assure these developments, patients must follow through and participate in these studies.
Every medical advancement—antibiotics, insulin injections, chemotherapy—was made possible because ordinary people like us stepped up to participate in clinical trials to bring life-saving and life-changing treatments to those who need it most. Your choice to participate in a clinical trial could be the reason the first-ever therapeutic drug for celiac disease is approved by the FDA. Your participation could even directly lead to the discovery of a cure.
No medication can become available to the public without 1) money, and 2) patients participating in trials to show the treatment works. Developing new drugs costs billions of dollars. That money comes from investors who need to be convinced that enough people want—and will actually use—the drug. If we want our need for better treatments and a cure to be taken seriously, we have to prove we are willing to do what it takes to make them a reality. The fastest, most convincing way we can do that is by participating in clinical trials.
We understand feeling uncertain about participating in research, especially if you have never participated in a study before. We put together a list of some of the most common perceived barriers to participating in clinical trials and studies. We address each concern with information that we hope encourages you to participate. The only way we will get better treatments and a cure for celiac disease is by each of us taking responsibility to do our part to improve the lives of the entire celiac community for generations to come.
If you haven’t participated in a clinical trial or study for celiac disease before, why?
Not all studies require you to ingest gluten. Some only require the administration of an investigational drug, or a simple blood draw. In the trials that do require a gluten challenge, patients are often given a purified form of gluten that may only cause minimal symptoms. Trials that require a gluten challenge do so to prove that a therapeutic drug protects celiac patients from gluten exposure, or alleviates the symptoms of gluten exposure. Controlled gluten exposure in a carefully monitored study is considered safe and will not cause long-term damage or ongoing symptoms after the study is complete, according to Dan Leffler, MD, MS, Medical Director of Takeda Pharmaceuticals, Director of Clinical Research at the Celiac Center at Beth Israel Deaconess Medical Center, and CDF Medical Advisory Board Member. While ingesting gluten for a short period of time during a study is unquestionably difficult, consider the incredible potential of never again having to experience symptoms from accidental gluten exposure if you had a medication to protect you.
2. I don’t think participating in a study would fit into my schedule.
Trials and studies have varying time frames – some may take months and some may only take 30 minutes. You can even participate in some studies from your own home. Researchers are often willing to find a time that works around your schedule. Even if a study or trial requires a good deal of time and attention, consider how much time you currently spend on managing the complexities of strictly adhering to your gluten-free diet. Consider how much time you lose to additional doctor’s appointments, sick days, meal prepping, etc. A few months may seem like a long time to participate in a study, but this investment in your future could potentially save you a tremendous amount of time spent managing your celiac disease in the long run.
3. I’m nervous about trying an investigational drug.
You do not have to take an investigational drug to participate in research. While clinical trials test an investigational drug, many studies only require blood samples or self-report questionnaires. Talk to your doctor about whether you’re a candidate for a trial or study, and which option is best for you. Keep in mind that researchers and drug developers must submit an Investigational New Drug Application to the FDA before any clinical trial begins. This application must include animal study data and toxicity data to show that the researchers have done their due diligence before using the investigational drug in humans. If you still have safety concerns, you might be more comfortable with a Phase 2 or 3 trial, rather than a Phase 1 trial. Phase 1 of a clinical trial tests a drug’s safety. If a drug is found to be safe during this phase, it will then move on to Phase 2, where it will undergo additional safety and efficacy testing on a larger number of participants.
4. I’m not interested in a treatment other than the gluten-free diet.
Many investigational treatments for celiac disease are not intended to eliminate the need for a gluten-free diet. Even when adhering to a strict gluten-free diet, many people still experience symptoms as a result of accidental cross-contact with gluten. Certain investigational treatments aim to protect patients from cross-contact while maintaining a gluten-free diet, rather than eliminate the need for a gluten-free diet altogether. It is also important to keep in mind that even though you may be happy with a gluten-free diet as your only treatment option, this is not the case for every patient. By participating in a clinical trial, you will be helping future generations of your family, who have a greater risk of celiac disease, to have the option to access an adjunct treatment to the gluten-free diet. We are also very fortunate to currently live in a time where gluten-free products are popular and abundant. When the number of people on a gluten-free fad diet lessens, gluten-free foods may become more difficult to find. This is another reason we need to be proactive about expanding our options while we have the opportunity to do so.
5. I don’t live near a major hospital.
There are clinical trials and studies held at smaller offices and even in your own home or office. Some trials assist in arranging transportation and accommodations in hotels. You can contact the researcher or study coordinator to find out if they provide these accommodations to eligible participants.
6. I’m worried I won’t be able to change my mind about participating after I’ve already started the trial or study.
Clinical trials and studies rely on voluntary participation. You are free to leave a clinical trial at any time, even after you have signed an informed consent form and received the investigational drug or placebo. However, you should always let the clinical trial team know before you decide to leave the trial because some medicines cannot be stopped safely without a doctor’s help.
7. I’m not sure what will be done with my blood samples and medical information.
No researcher is able to access your medical information or use your blood samples without your consent, and you will be informed for what specific use your samples and information are used. When the data from studies are analyzed and published or presented, it is completely anonymous (you cannot be identified) and only shared as pooled data that is combined with other participants’ data to show overall results. Researchers can only use samples or information for the specific purposes for which you consented.
8. Clinical trials and studies do not seem safe. I don’t want to gamble with my health and risk a bad outcome.
Many measures are in place to protect the safety of trial and study participants—from careful study design to oversight by institutional review boards and periodic monitoring of study data by independent experts. Before you begin any trial or study, you will be given a detailed informed consent form which will outline the possible benefits and risks to participating in that study. You will have the opportunity to discuss any questions or concerns you may have prior to signing the consent form and participating. You have the option to change your mind and decide not to participate at any time. Participants receive regular medical attention and are closely observed for any safety concerns. During the study, researchers must inform you of any new risks, benefits, or side effects they discover.
9. I can’t think of any reason I would want to participate.
If you are participating in a clinical trial where you are being given an experimental therapy, you may be one of the first people to benefit from the drug. Even if you might not receive any immediate health benefits from participating in a study, you may benefit in the future from the new knowledge or treatments your study can help discover. You can also benefit by knowing that you could be helping millions of other patients in need of a therapy or treatment, and your future generations since celiac disease is genetic. For both clinical trials and studies, you will typically receive monetary compensation for your time.
10. I don’t know where to find current clinical trial or study opportunities.
We have several resources to help you find study opportunities for which you may qualify. Visit our Participate in Research page to see trials and studies for which we are currently recruiting or view our Clinical Trial Finder to search current registered trials by location. Make sure you are also signed up for iQualifyCeliac, our clinical study screening tool, which allows you to apply for open studies and find out if you may qualify to participate within minutes. iCureCeliac® is also an easy way to participate in research from anywhere. By sharing your health information and critical insights in our patient research network, you can accelerate research towards better treatments and a cure. When you’re an iCureCeliac® participant, you’ll also be the first to hear about our new study opportunities.
Do you have other questions or concerns about participating in clinical trials and studies that we haven’t addressed? Contact us at [email protected], and we will be happy to speak with you about participating in research to help improve the lives of everyone affected by celiac disease.