On July 20, 2017, the Crohn’s & Colitis Foundation launched a Clinical Trials Community (the Community) for the education of patients, family members, caregivers and healthcare providers regarding the study of irritable bowel disease (IBD). Specifically, the community will provide education on the clinical trial process as well as its value for facilitating improvements in care. Subsequently, this process may help reduce barriers to patient enrollment in IBD clinical trials, thereby enabling faster routes to therapeutic discovery.

Crohn’s disease is a chronic inflammatory bowel disease (IBD) affecting the digestive tract, and is associated with significant abdominal pain, weight loss, diarrhea and a reduced quality of life. Close to 1.6 million people in the U.S. have IBD, and 70,000 newly diagnosed cases occur each year. Clinical trials have helped researchers develop a deeper understanding behind the underlying mechanisms of the disorder while improving treatment options for patients. Further trials are crucial for advancing treatment options even further; however, challenges exist in patient recruitment, resulting in stalls in the development of new treatments.

Courtney Bisbee, MPH, Manager of Patient Education at the Crohn’s & Colitis Foundation, believes the lack of patient awareness and understanding of the clinical trial process can be a significant barrier to patient recruitment. “From this limited understanding, patients may fear that symptoms might get worse during a trial, or they might be assigned the placebo,” Bisbee said. “There is also little dialogue about clinical research between patients and their healthcare providers. Our hope is to really drive home the fact that every treatment currently available for patients today was only made possible by countless other IBD patients before them who participated in a clinical trial.”

The value of clinical trials in accelerating development of new IBD treatment options is undeniable. Research in genetics, microbiology and immunology have provided direct insight into the behavior of the disease as well as its response to targeted therapy. Knowledge deficits related to the clinical trial process, however, can lead to delays in recruiting appropriate subjects.

Chris Trizna of CSSi, a patient recruitment and enrollment firm, also believes education to be the number one stumbling block to appropriate patient recruitment. “Education and awareness of clinical trials is probably the number one challenge. People are not educated on the process of clinical trials and don’t understand what is involved with participating in a study,” Trizna said. Family physicians are at the forefront in educating patients about available research opportunities, Trizna mentioned, and the use of easy-to-read brochures, flyers and digital media can help engage patients and facilitate enrollment.

The Community is aimed at addressing the barriers to patient recruitment and enrollment through awareness, education and support resources. According to Bisbee, the Community’s website includes visual infographics of the types, phases and processes of clinical trials, a video series featuring key people within a trial, patient stories and a research findings page to educate patients on research advancements.

Identifying and reaching the target audience for a clinical trial can be tricky, since some studies are hospital-based and the ability to advertise is often limited. Once the targeted audience member (patient, caregiver, family member, etc.) is identified, education about the clinical trial and the patient’s involvement becomes the top priority. “When people find out about a study, providing them with good information helps them make an educated decision about participating. The more information a person has, the more likely they will participate in research,” Trizna commented.

According to a 2015 analysis by Mahon et al., approximately 19% of registered trials are terminated because they do not meet their recruitment goals.  Additionally, it has been found that 90% of completed clinical trials experience significant delays due to similar setbacks.  Extension of these trials often translates to delayed therapy development. In turn, this may contribute to the rising morbidity and mortality associated with certain diseases. Trizna mentioned that a number of factors play into patient recruitment barriers, including restrictive exclusion and/or inclusion criteria, the length of the study’s duration and number of study visits and the complexity of consent forms. The number of data points some clinical trials are attempting to collect can also make a trial seem too daunting for trial participants.

The drug process for any disease or disorder relies on well-designed and executed clinical trials. Since many patients with IBD fail to respond to initial treatment and often lose responsiveness to treatment over time, the disease may be difficult to manage for some patients. “It is critical to have many treatment options; yet we are still seeing only a very small percentage of IBD patients participating in clinical trials to help bring new treatments to market,” Bisbee added. With the Community in place and implemented in strategic patient-centric areas, the Crohn’s & Colitis Foundation hopes to close that gap between the patient and a successful clinical trial, ultimately improving timely drug development and delivery to
IBD patients.

This article was reprinted from Volume 21, Issue 30, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »