How to Improve Diversification of Patients With Cancer in Clinical Trials

Alexander M. Castellino, PhD

March 20, 2018

Underserved populations who experience cancer health disparities are underrepresented in clinical trials and biobanks. What would it take to fix this disparity?

Data gathered from focus group and individual interviews in urban and rural communities in Louisiana suggest that people experiencing these disparities would be interested in participating in clinical trials or submitting samples to biobanks if provided information about these opportunities from a physician they trust.

However, physicians also confess to lacking appropriate information to give their patients.

These were some of the insights shared by Terry C. Davis, PhD, professor of medicine and pediatrics at the Louisiana State University Health Sciences Center in Shreveport, during a media preview for the American Association for Cancer Research (AACR) 2018 Annual Meeting.  

Fewer than 5% of patients with cancer of low socioeconomic status, from racial and ethnic groups, and living in rural areas are enrolled in clinical trials. Davis suggested that "diverse participation is necessary to identify how specific drugs and treatments are most useful for different groups."

"Our results show that participation of populations underrepresented in clinical trials and biobanking could be enhanced by developing working relationships with community clinics because community providers are conduits to patient participation," Davis said in an AACR news release.

Study Details

Davis and colleagues held 14 focus group and conducted seven individual interviews. In total, 103 individuals participated in this study; of these, 78 were clinic patients and community participants (85% women, 78% African Americans) and 25 were safety-net healthcare providers. Twenty-five percent lived in rural areas, and 70% reported having lower income.

Davis pointed out that almost all individuals were interested in participating in clinical trials but are not aware of the studies, do not know how to find out about them, or do not know how to enroll in them. "Most are willing to participate, but never asked," Davis said.

Most participants indicated that they would enroll in genomic studies, particularly if those studies would benefit their grandchildren —  even if it was no benefit to them. However, there was some concern about who may see the information and whether it would be a barrier to getting a job or insurance. According to patient and community participants, information would most effectively be disseminated by a trusted healthcare provider. None of the participants suggested that the Internet would be a place they would go to for appropriate information.

In rural areas, transportation is a huge barrier to participating in clinical trials. "Mobile health vans could enhance participation," Davis said.  

However, according to Davis, effective strategies are needed to help underrepresented populations see value in participating in clinical trials. The report suggested that communications may have to be better defined. "Clear, plain-language, accessible information of clinical trials and genomics and biobanking for community clinic providers, their patients, and the public is lacking," Davis said.

Acceptable communication would require a change in vocabulary. Participants understood the term "study" but not "trial." "Biobanking" would be better communicated as "your blood or tissue would be stored in a bank." The term "genomics" sounded alarming and intimidating. "It did not mean anything to most participants," Davis said. The terminology "minorities are needed in clinical trials" was not well received. "All people are needed for studies to improve treatments and find cures" was elected as more appropriate.

Targeting minority recruitment makes it appear suspicious, Davis pointed out. "Some remember Tuskegee," she said. Participants wanted to know: "What are you going to do with my blood sample? How much information about me are you going to keep? What is it going to be used for?"

"Enhancing communication is a key priority moving forward. Since a trusted provider is essential for enrollment, these trusted providers and their patients need to have access to clear, culturally appropriate, unbiased information on genomic trials, and their potential risks and benefits. This should happen before anyone is asked to participate in a particular study, not during the consent process," Davis commented in an AACR news release.

The AACR Initiative: 2020 by 2020

AACR President and one of the session's moderators, Michael A. Caligiuri, MD, PhD, said, "This study provides an important message to access barriers about not providing equal access and equal care to underserved group."

"For all cancers combined, the death rate is 25% higher for African Americans compared with whites," Caligiuri pointed out. "This study points out some of the problems," he said.

"While there are many likely causes for this [higher death rate], we need to make sure we have tumor DNA sequenced from all patients' tumors in order to understand these differences in outcomes," Caligiuri said.  

To this end, AACR is spearheading an initiative to address cancer health disparity known as "2020 by 2020," Caligiuri noted. To improve the understanding of cancer outcomes in an underserved population, the initiative aims at performing genomic sequencing of both tumor and normal tissue from 2020 consenting African American patients with cancer by the year 2020. 

This initiative is being undertaken in partnership with Pelotonia, M2Gen, and the Oncology Research Information Exchange Network. The partners are developing an infrastructure for consenting African American participation. It is hoped that the initiative will substantially increase the number of patients, be self-sustaining, and will continue to accrue patients beyond 2020.

Caligiuri indicated that the data will be added to the AACR Project Genie registry, which has already made public 39,600 de-identified genomic records.

He also noted that the data generated through this initiative will be available to publicly accessible cancer genomic registries for the benefit of studying cancer and cancer outcomes in African Americans.

"Such research has the potential to deepen our understanding of the health disparities in this population and expedite the development of strategies to address this daunting public health challenge," AACR noted in the news release.    

Davis and coauthors have disclosed no relevant financial relationships.

American Association for Cancer Research (AACR) 2018 Annual Meeting. Abstract 3010. To be presented on April 16, 2018.

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