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Digestive Disease Week

Strategies for Recruiting Diverse Study Populations in GI Clinical Trials

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


 
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