Diversity in Clinical Trials Improving, but We’re Not There Yet

March 8, 2019 Darcy Grabenstein

An advocate for diversity in healthcare

Dr. Jean Bonnet, originally from the southern part of Haiti, credits his parents — who never had the chance to go to school — with his success today. He calls them his “greatest professors” who, despite everything, told him there’s no limit to what one can achieve.

Their advice paid off. In his early years (and to this day) he worked hard, on both his career and his language skills. One of his first positions in this country was that of a janitor at a nursing home. He told his boss that one day he’d come back as a physician. However, he said his English was so poor that he could barely could communicate. “If you can’t articulate, others judge your knowledge and ability,” he noted. He held other jobs, including driving a taxi and working in factories, to save up enough money to study medicine in Mexico.

After an internship in Trinidad-Tobago, he returned to the U.S. Today, Dr. Bonnet is an internist in Hyde Park, Mass, where his focus is on cardiovascular disease and diabetes. In practice for more than 25 years, he received his medical degree from Universidad Autonoma de Guadalajara.

When it comes to diversity in healthcare, he knows from experience. His interest in community and sensitivity to the fact that it’s a melting pot is reflected in his work. To him, culture and medicine are intertwined. He is particularly interested in the psychosocial, cultural and biological origin of disease and research.   

As a young physician, he worked to educate the community about numerous health issues. Dr. Bonnet worked with the HIV community, which he said was defined by four H’s: hemophiliac, homosexual, habitual drug users and (hitting close to home for him) Haitians. It was his work with a multicultural AIDS coalition that heightened his interest in multiculturality. He served as president of the Ethnicity and Disease Research Center, an organization looking disparity in healthcare, integration of ethnic minority physicians in research and cultural/linguistic measures in the healthcare system.

In 2008, Dr. Bonnet founded the Ethnicity and Disease Community Empowerment Center, whose mission is to reduce health disparities in minority communities with a unique approach to patient care and community involvement that includes culturally sensitive health literacy campaigns, community-based health screenings and its culturally conscious health education TV program. He is co-owner of MCTV Boston, a multicultural television channel that seeks to provide a platform for physicians and community leaders to educate ethnic communities.

In 2017, Dr. Bonnet was named a Hometown Hero, nominated by members of the community to nominate as someone who has had major impact on his community. Last year, Dr. Bonnet was one of four black immigrants honored by Boston city councilors for making significant contributions to their communities and neighborhoods.

Challenges of enrolling minorities in clinical trials

The NIH Revitalization Act of 1993 requires all federally funded clinical research to prioritize the inclusion of women and underserved racial and ethnic groups. Yet statistics show that between 1993 and 2013, less than 2 percent of cancer studies, for example, have included enough racial and ethnic group participants to report relevant results.

Dr. Bonnet said that, despite this regulation, the reality is different. Pharmaceutical companies are not philanthropic organizations. They are businesses and must show profit. However, lack of diversity could end up costing the healthcare system because “it lessens the outcomes.” For instance, blacks excluded from cardiovascular studies may end up having more complications, which costs more money.

The patients themselves are partly to blame for lack of representation, said Dr. Bonnet, albeit often for historical reasons. In the past, blacks were used as guinea pigs (syphilis studies, as a case in point), so there is a lack of trust on the part of participants. Education is a must, he emphasized.

He explained that minorities should be included in studies because their symptoms, reactions to medications and even physiology are different. The mass of the heart chamber, for example, varies from one ethnic group to another. Cough, edema and closing of throat are more common in blacks than others on medication for hypertension. One-fifth of new drugs approved between 2008 and 2013 showed racial differences in drug response that were, in some cases, significant enough to impact prescribing decisions. 

“We talked to some pharmaceutical companies about the importance of culture and medicine, knowing that not all medication works equally for all ethnic groups,” said Dr. Bonnet. “We can’t use one size fits all.”

Boston Scientific proved the exception to the rule with its  PLATINUM Diversity Trial, a study of 1501 women and minorities from 52 sites across the U.S., with the objective of enriching these traditionally underserved patient populations. While the trial focused on the effectiveness of a stent system, the study produced one undeniable conclusion: Trials can no longer be filled with white male patients. 

Location, location, location

Geographical disparity is also an issue for clinical trials. In an article in Outsourcing Pharma, Prof. Melinda Mills of the University of Oxford said researchers conducting the first empirical review of all genetic discoveries found a “remarkable 72 percent of people came from three countries”: the UK (40 percent), the U.S. (19 percent) and Iceland (12 percent). Compare this with the fact that 76 percent of the world’s population lives in Asia and Africa, while Iceland has just over 300,000 people.

Dr. Bonnet concurred, noting that about 80 percent or more of clinical trial participants are white. He attributes this to the fact studies are often conducted in more affluent countries, among races with more financial capacity. His said this discrepancy trickles down to treatment. “Let’s say we know the impact of cholesterol on cardiovascular disease. So we tell the patient not to eat hamburgers. But that patient may be homeless. Does he worry about the nutrition content? For those living on the survival line, health is simply not a priority.”

Financial status also presents a barrier to clinical trial participation. For example, Dr. Bonner said lower-income patients may not be able to afford taking time off from work to participate in a clinical trial. “How can this be called science when there’s so much exclusion?” he asked.

He also cites language and cultural barriers as reasons for lack of minority representation. This makes it particularly difficult, he said, adding that even 10, 15 or 20 percent increase in participation would make a big change.

Lack of gender diversity is also an issue in the research community, with 70 percent of senior last author positions held by men, Mills noted in the article. The researchers came up with 10 policy recommendations, including those on ancestral, geographic, environmental, temporal and demographic diversity. Mills said diversity gaps in research should be monitored, with funding sanctions and consequences.

Grassroots communication most effective, with health literacy an imperative

Corporate and sometimes academia are not community sensitive or culturally competent to penetrate ethnic minorities, said Dr. Bonnet. “It’s not easy; these minorities are living in their bubble. They’re living on an island with no bridge to the mainland.”

The only way to strategically penetrate these communities, he said, is to use representatives of those minorities who know their communities, can educate others and bring them in. He said nurses and nurse practitioners are two groups of professionals who have indicated a willingness to do educational outreach in the community. Churches and community organizations are great starting points, he added.

Dr. Bonnet said that, while sponsors’ clinical trial websites help make studies more accessible, there still may be cultural, generational and international gaps. That’s why sites should have translation available, for example. Sponsors trying to reach older patients should know that they often rely on their children or grandchildren to help them navigate the internet. And health literacy is a must, with trial information presented in easily understandable terms.

“Ignorance equals fear,” he said. “The strongest barrier you could have to participation is misinterpretation of facts.”

Patients are key to the process

In order to promote diversity in clinical trials, Dr. Bonnet said pharmaceutical companies need someone internally to advocate for this. “You cannot have an effective advocacy program without patient participation,” he cautioned.

For healthcare organizations to truly provide patient-centered care, Dr. Bonnet said patients must be part of the process. “Health is a political issue, a financial issue. But it also must be about the patient.”

 

 

About the Author

Darcy Grabenstein is Senior Manager of Content Marketing Strategy at TrialScope. With a background in journalism and public relations, she has 30-plus years of experience in communications.

More Content by Darcy Grabenstein

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