TORONTO – Offering training to community-based physicians on how to conduct clinical trials is one of many steps the federal government can take to increase minority participation in research, according to recommendations unveiled by the Endocrine Society at its annual meeting.
“Recruitment is very difficult and no matter how much work people do in the community, in the end people go to their doctors and they take the advice of their doctors,” said Dr. Maria Alexander-Bridges, who is head of the Endocrine Society task force that developed the recommendations.
“So we wanted to work primarily on training minority physicians to do research in clinical trials so as to change the face of this process.”
The task force's effort, which began last year, was funded by a grant from the Robert Wood Johnson Foundation's Program on Disparities in Health Care.
One of the first steps recommended by the Endocrine Society was to convene a summit that would include pharmaceutical companies, academia, federal agencies, HMOs, community health networks, and community leaders, said Dr. Alexander-Bridges, who is also at Harvard Medical School, Boston.
The summit would address lingering questions that are critical to improving minority patient recruitment. For example, stakeholders would need to consider whether recruitment should be based on the percentage of certain minority groups in the population or on the number of patients of each subpopulation needed to generate statistically significant data.
Another unresolved question is how to define a minority group, she said.
The Endocrine Society also recommended that:
▸ Congress pass legislation that requires the inclusion of women and minorities in clinical trials for approval of drugs by the Food and Drug Administration.
▸ Congress provide tax incentives or patent extensions to companies that adhere to FDA guidance on the inclusion of minorities in trials.
▸ Officials at the National Institutes of Health and academic institutions establish an infrastructure of minority patient populations from which individual investigators can recruit volunteers.
▸ The NIH create and fund community research advisory boards to promote community-based research.
▸ Medical schools increase enrollment of minority students based on projected population changes over the next 30 years.
“Pharmaceutical companies will understand that this makes good sense,” said Dr. Alfonso Alanis, a member of the Endocrine Society task force. “We need to present this as a business proposition.”
Dr. Alanis, who is a former executive at Eli Lilly, and now is the founding partner of Anaclim, a contract research organization that aims to bring more minorities into clinical research, said his company has had success so far in recruiting minorities to studies.
Working with minority investigators accounts for about 80% of the company's minority recruitment, Dr. Alanis said. About 20% are nonminority investigators who care for minority patients.
Despite the common refrain that minority patients don't trust researchers, Dr. Alanis said the minority patients he has worked with understand the value of being represented in clinical trials.
They may have questions, but they are willing to participate, he said.
Dr. Rhonda Bentley-Lewis, an instructor in medicine at Brigham and Women's Hospital in Boston and a clinical investigator, said she tries to overcome issues of distrust by developing relationships within her community.
For example, she speaks in the community about diabetes prevention and management but doesn't use those talks as a sales pitch for patients to participate in clinical trials.
Dr. Bentley-Lewis, who was also a member of the Endocrine Society's task force, said that one measure of the trust-building these talks provide is that individuals often approach her with questions that they don't ask their own physicians.
When individuals do agree to participate in a trial, she gives them a chance to learn about the study in depth and emphasizes that their relationship is a “partnership,” she said.