Strategies for Recruiting Diverse Study Populations in GI Clinical Trials

A common problem in clinical trials, including those researching gastrointestinal (GI) diseases, is a lack of diversity in study groups. Speakers at Digestive Disease Week 2017, held May 6-9 in Chicago, discussed the roots of this issue and what they have found can be done to address it.

Moon S. Chen Jr, PhD, MPH, professor of hematology and oncology at UC Davis Comprehensive Cancer Center, began his presentation by exploring why some racial and ethnic minorities are reluctant to participate in research. “There are 2 words in the English language that are barriers,” he said, “clinical trials.” “Trials” can evoke thoughts of court cases or being a guinea pig, while “clinical” is a nebulous idea. “We in the biomedical world need to think about translating this into lay terms if we want to be successful,” Chen explained.

Another problem besides terminology is the relatively small amount of clinical trials that focus on how a particular disease impacts minorities. However, his research has found that intentionally engaging patients as active partners makes participation more likely.

Chen showed the audience a pyramid that represented a paradigm of solutions to encourage diversity. The foundation was trust, which must be built between the patient and the provider, while the next level was time, or the time and effort that must be invested in building this trust. Next was tangible benefits, or explaining to prospective participants how this research could benefit not only their own clinical outcomes but add to the knowledge base for people of their race or ethnicity. Finally, at the tip of the pyramid was tools or techniques, like the recruiting materials which should be translated into different languages and show a diverse group of subjects.

The next speaker, Samir Gupta, MD, MSCS, AGAF, associate professor at UC San Diego, discussed his framework of “effective strategies to ensure diversity in clinical trials.” First, investigators must determine goals, and think about how the research will add value for both the provider and the patient. Next is the incorporation of community-based participatory research principles, which indicate that the study and its research team should be embedded into the community health systems already serving the target populations. This can be “challenging and time-consuming,” but is necessary for building trust, Gupta said.

This research team must be culturally sensitive and language concordant, and ideally will be hired from within the community and reflect the community demographics. Finally, the interactions with patients must be optimized, meaning they should be tested for cultural competence. Gupta gave the example of a colorectal cancer screening initiative called Project Poli, which was aimed at Hispanics but initially had a very low response rate. A pilot test revealed that the target audience thought the mailed invitation was a letter from the police.

“Equity in chances to benefit from research will require extra, but highly worthwhile, effort and resources,” he concluded.

Bringing a different perspective to the session was Regina Smith James, MD, director clinical and health services research at NIH’s National Institute on Minority Health and Health Disparities. She discussed the institute’s mission to “lead scientific research to improve minority health and reduce health disparities” and summarized the resources available to researchers designing trials.

She highlighted the efforts of the 5 institutions participating in the EMPACT Consortium, which was formed to enhance minority participation in clinical trials. Some of the resources that have been successful are web portals, patient navigation programs, and the presence of a “clinical trials ombudsman” at each site to provide support for study participants.

James closed her talk by challenging the common idea that “it costs a lot of money to engage diverse populations.” She challenged the audience “to go back to your offices and to your practices and see if simply making your patients aware of clinical trials” has more of an impact than they might expect.

The final speaker was Lea Ann Chen, MD, assistant professor of medicine at NYU Langone, who recently received a research scholar award for her studies of inflammatory bowel disease (IBD) pathophysiology in a multiethnic safety-net population. She said that the risk factors for IBD were poorly understood in non-Caucasian populations, and hoped that identifying any differences could impact the current approach to diagnosis and treatment and may even reveal unnoticed disparities in healthcare.

Beyond the findings of gut microbiome differences in IBD patients who responded well to treatment and those who did not, Chen said the study taught her some other important and unexpected lessons, like the “symbiosis of clinical care and research.”

“My research subjects get improved clinical care when I get them into a study, and certainly there are research benefits when more patients are enrolled,” Chen explained. However, the clinical trial process also helped patients become more comfortable in a healthcare setting and made them better able to navigate the health system. “It’s been really rewarding to see how patients become empowered to play an active role in their disease management,” she concluded.