Saturday, April 21, 2018
Health

Black results matter: New program aims to boost minority participation in clinical trials at USF, Moffitt

John Harrell was out of options.

Diagnosed with a rare form of non-Hodgkin's lymphoma in 2009, he had tried everything available. The seven drugs and two types of radiation didn't stop his cancer, nor did the bone marrow transplant.

"I had to take a risk," he said. "None of those treatments gave me remission. The disease would always win."

So in 2013, Harrell, 48, became one of the few African-Americans to try an experimental drug being tested in a clinical trial at Moffitt Cancer Center in Tampa.

Those in the business of clinical trials would like to see more volunteers like Harrell, and a new local effort is trying to make that happen.

The vast majority of clinical trial volunteers — 80 to 90 percent, according to some studies — are white, adult, non-Hispanic males. Not included in that number are trials that recruit only specific groups.

The lack of diversity was frustrating for pharmacologist Kevin Sneed, dean of USF's College of Pharmacy. He knew from years of working with drugs and clinical trials that subtle molecular, cellular and genetic differences between racial and ethnic groups can influence the way each responds to treatment.

"Maybe it's the way they metabolize a medication or sodium, for example," Sneed said. "If you don't have enough genetic variability in your trial, you are forced to assume that the treatment will work the same in all groups of people, and we can't do that."

Drugs react differently in women than in men, in children than in adults, and in 30-year-olds compared to someone who's 85, he explained. "Until you study a treatment in enough members of a particular group, you can't predict what the outcome's going to be."

So Sneed developed a program he hopes will encourage more minority patients to volunteer for trials.

Clinical trials are the gold standard for finding out whether medications, medical procedures and devices are safe and benefit patients. At any given time, hundreds of trials are under way at medical centers and laboratories across the country. And thousands of volunteer patients are enrolled, the vast majority of them adult white males.

According to a 2011 FDA report on clinical trial participation, only 5 percent of U.S. study volunteers are African-American and 1 percent are Hispanic. In federally funded cancer research, 8 percent of participants are African-American, 5.6 percent are Hispanic and 2.8 percent are Asian/Pacific Islander, according to a 2006 National Cancer Institute study.

The problem is those numbers do not reflect the health care landscape. African-Americans and Hispanics, for example, have higher rates of diabetes, HIV/AIDS and obesity than whites, yet most of the drugs that treat those conditions have been tested primarily in Caucasian men, according to the FDA's Office of Minority Health.

Why so little minority participation?

The infamous Tuskegee syphilis experiment is often cited as a barrier. In the 1930s, during the Great Depression, poor black men were enrolled in a federal clinical trial without fully understanding the research or giving fully informed consent, and without being given currently available treatment.

But recent research into the long-term fallout from that study found other reasons are to blame as well, including the complexity of consent forms, language barriers, lack of transportation to and from study sites, cultural beliefs about Western medicine and minorities simply not being asked to participate.

At Moffitt, one of Lee Green's main jobs is to find ways to increase ethnic and cultural diversity in clinical trials. He admits it can be difficult, and looks forward to Sneed's new program for help.

"The time is right for a new initiative," said Green, who is vice president of Diversity and Community Relations at the center.

"There might be some treatment that would be more toxic in one group compared to another, and you might not find out about that difference until the drug is out in the marketplace. We want to find that out in a trial."

The cornerstone of Sneed's program will be a group of five community members who will make up what he calls the Community Research Review Committee. They will meet with researchers, learn about each clinical trial and take the request for volunteers to minority communities — primarily through a network of religious, social and civic groups. In essence, the group will be giving its stamp of approval to the study and encouraging minorities to join.

"We are asking that at least one CRRC member has some science background so that they understand the research and the medical conditions and can explain it in layman's terms to others," said Sneed, who developed the program over several years with the help of an NIH grant, a team of 10 graduate students and a fellow College of Pharmacy faculty member.

He said he expects it to be available for all researchers at USF and Moffitt by early 2016.

Harrell, the lymphoma patient, said he's glad he was offered a new, experimental drug that was in development and credits it with putting his cancer into remission. He says he looks forward to the launch of Sneed's program, and is anxious to see more minorities participate in clinical trials.

"If we don't lend ourselves to these studies, we're going to miss out," he said. "If a cure comes out and we find it only works for certain populations, we can't scream racism. We tried to recruit you on the front end. I feel an obligation to be on the front end of this fight."

Green says sharing stories like Harrell's and providing education to under-represented groups about clinical trials is key to getting them involved in medical research.

"People don't realize that clinical trials extend and save lives in some cases," he said. "Dr. Sneed's work will supplement what we're already doing at Moffitt to diversify clinical trials. Working together we can have a much bigger impact."

 
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