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Clinical trials are necessary for finding new ways of preventing, detecting or treating diseases.  

Often, though, 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 role clinical trials play in health care may help you find a new treatment for a disease such as cancer or manage a condition such as IBD more effectively. 

Importance of clinical trials 

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. 

• 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 on the study. Each clinical trial has its own goals, which means different trials have different criteria. 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. 
• 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. 

• 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 or parking.

Trial sponsors commonly cover these costs, as well as any non-routine patient care that isn’t covered by insurance.  

• Leaving the study: At any point you wish to drop out of the trial, you can — for any reason. 

How to learn more 

If you’re interested in participating in a clinical trial, go to trusted sources to learn more and ask questions. For example, NIH, Johns Hopkins, Veterans Affairs, UMD or 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.  

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

This story was sponsored by the Crohn’s & Colitis Foundation.