Clinical trials are necessary for finding new ways of preventing, detecting or treating diseases, but often, limited participation creates challenges for meeting clinical trial goals. Despite decades of effort and strategies to identify and address barriers to recruiting and enrolling study participants, recruitment challenges persist, particularly among women, older adults and diverse patient populations.

“Potential study participants are reluctant to get involved for a variety of reasons, including the time commitment, lack of clarity regarding safeguards for their well-being and concerns about how their medical condition will be handled during the study,” said Alan Moss, MD, chief scientific officer with the Crohn’s & Colitis Foundation, the leading nonprofit organization focused on both research and support of people living with inflammatory bowel disease (IBD). “Taking part in a clinical trial gives patients an opportunity to access new therapies and can help shape future treatment, including how diseases are diagnosed, treated and even prevented.”

Learning more about the important role clinical trials play in health care may ultimately help you or someone you love find a new treatment or manage a condition, such as IBD, more effectively.

Importance of Clinical Trials
Finding a treatment that relieves patients’ symptoms and helps induce and maintain remission is important. However, these treatments wouldn’t be available without clinical trials. In fact, all U.S. Food & Drug Administration (FDA)-approved medicines currently available on the market are the result of clinical trials and the patients who participated in them. When enrollment targets aren’t reached due to low patient participation, there may be delays in the drug approval process.

What You Should Know
There are plenty of reasons to consider participating in a clinical trial, especially if you’re looking for further options to treat a serious condition. Taking part in a clinical trial is a big step, so it’s important to be well-informed.

• Safety: Investigational treatments must be studied extensively before the FDA will approve them. Each trial follows thorough protocols to ensure the health and safety of its participants. Additionally, patients are followed continuously throughout a trial to monitor their health.

• Eligibility: Who can participate in a clinical trial depends greatly on the specific limits of the study. Each clinical trial has its own goals to achieve, which means different trials have different criteria for patients to meet in order to enroll. Some trials are for patients who have moderate to severe disease and others may seek patients with mild disease. Other trials look for patients without any diagnosis. Prior to enrolling in a trial, a research coordinator will review your complete medical history to see if you meet the inclusion criteria.

• Treatment: When you decide to enroll in a clinical trial, you may have access to the study drug as a form of treatment. Typically, participants will not know if they are receiving the study drug during the trial. This helps reduce potential biases and ensures the fairness of the trial. However, all participants are monitored closely. If there is any change in your medical condition while participating in the study, the research staff will inform you immediately and discuss the situation.

• Cost: The majority of clinical trials are federally or privately funded, so there is typically no cost to participants. While federal law requires most health insurance plans to cover the majority of routine patient care costs associated with clinical trials, there are some costs you may incur, such as travel, gas, parking, child care and time away from work. Trial sponsors commonly cover these costs, as well as any non-routine patient care that isn’t covered by insurance. However, it’s a good idea to get a clear understanding of how the trial you’re considering would handle these expenses.

• Leaving the study: At any point you wish to drop out of the trial, you can, and for any reason. In that case, it’s common for a research coordinator to ask you to complete a final visit and schedule follow-up visits, if needed, to ensure you do not experience any side effects.

How to Learn More
If you’re interested in participating in a clinical trial, it’s important to go to trusted sources to learn more and ask questions. For example, the Crohn’s & Colitis Foundation can point you toward clinical trial opportunities. Your doctor’s office can also be a good source of information about local studies.

If you’re hesitant about joining a trial involving a treatment but are eager to help, you might consider other types of research studies, such as prevention, diagnostic, screening or quality of life trials instead.

Once you identify a clinical trial that interests you and you may be eligible for, contact the research coordinator to learn more. You’ll also want to discuss the study in greater detail with your doctor and talk to loved ones within your support system who may have questions or helpful insight to consider.

Visit crohnscolitisfoundation.org/clinical-trials-community to learn more about IBD clinical trials and find opportunities near you.

Understanding IBD
Inflammatory bowel disease (IBD) affects nearly 1 in 100 people living in the United States, according to a study led by the Crohn’s & Colitis Foundation. IBD is an umbrella term used to describe disorders that cause chronic inflammation of the gastrointestinal (GI) tract.

Symptoms include diarrhea, as well as abdominal pain, nausea, fever, loss of appetite, fatigue and, at times, rectal bleeding. No single test can confirm IBD, which includes Crohn’s disease and ulcerative colitis. There are currently no cures for IBD. Medication and managing your diet and nutrition are two of the most common treatment recommendations.

 

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Sponsored by Crohn’s & Colitis Foundation