Clinical Trials Need Minority Participation to Close Gap


NEW YORK — Racial disparities in access to health care will disappear only when adequate and representative samples of minorities participate in clinical trials, Winston Price, M.D., said at the annual meeting of the National Medical Association.

That disparities in delivery of health care exist is not in question. The Institute of Medicine report “Unequal Treatment: Confronting Racial and Ethnic Disparities in Healthcare” revealed the extent of the problem, showing that disparities remain even after adjustment for factors such as insurance coverage and socioeconomic status.

But a widespread mistrust of the U.S. health care system among minorities—not least because of past abuses such as the Tuskegee Syphilis Study, in which blacks went untreated for many years despite the availability of effective therapy—has led to an unwillingness among African Americans to participate in the clinical trials that might directly benefit their own health.

An increasing understanding of genetic and racial differences in response to medications makes it imperative that minorities be included and their needs addressed in the drug development process, said Dr. Price of the State University of New York Health Science Center, Brooklyn.

The experience with BiDil, a fixed-dose combination of isosorbide dinitrate and hydralazine approved specifically for the treatment of heart failure in black patients, shows it can be done.

“You had 1,050 African Americans who enrolled in the study, and the attrition rate was zero,” Dr. Price, who is also president of the NMA, said in a press briefing. “Every single one stayed with that study until completion. The drug was approved by the Food and Drug Administration on June 23, not because it was the right thing to do but because it was pure science and evidence based.” Other models also are demonstrating blacks can be recruited successfully, Christopher L. Edwards, Ph.D., said.

Programs that are successful tend to be well entrenched in the community; they have good outreach and education and relationships with local organizations such as churches and fraternities, Dr. Edwards said.

They do not pressure potential participants, but provide information and allow patients to process it at home and respond when they are ready, he said.

Successful investigators are available to the community not only when recruiting; they are able to articulate the tangible benefits of participation, not only for patients themselves but also for future generations. Dr. Edwards' program in the department of psychiatry at Duke University Medical Center, Durham, N.C., is an example.

“We make ourselves available for interviews on television, religious radio, and pop radio. In one creative marketing plan, we placed advertisements for one of our genetic studies on the side of 20 city buses, and have seen a significant number of patients responding.” he said.

The strategy of information dissemination is to go where the patients are, and not to rely on them to come to us, he said. “With the bus advertisements, the demographic we were recruiting was reliant on public transportation,” he added. And the ads provided phone numbers, not e-mail addresses or Web sites because those would not be helpful for any potential participant who did not own a computer.

In the Duke program, the relevant stakeholders are at the table when recruiting programs are being designed. “If we are recruiting college students, we had students who sat on review panels and advisory boards to give us guidance as to what they would respond to, how, and in what setting,” Dr. Edwards said.

Another panel member, Rahn K. Bailey, M.D., said throughout his career he has been interested in issues such as differences in drug metabolism between African Americans and other patients. For example, about 40% of black patients are slow or intermediate metabolizers of many psychiatric medications, said Dr. Bailey of the department of psychiatry and human behavior, University of Texas, Houston, and chair of the NMA psychiatry and behavioral sciences section. As a result, black patients tend to experience more toxicity, and efficacy may be compromised.

“It's not surprising to me now that many of my patients over the years have had great difficulty getting better, relapsed a lot quicker, come back to the hospital frequently, and ended up in the legal system because of clinical issues that were not addressed medically,” Dr. Bailey said.

Audience member William Lawson, M.D., brought up the work of Surgeon General David Satcher, M.D., Ph.D., in his 1999 report “Mental Health: A Report of the Surgeon General.” One of the points made was that virtually all U.S. psychiatric studies included primarily white males, so almost all psychiatric drugs had less than 1% African American representation, said Dr. Lawson, chair of psychiatry, Howard University, Washington. “And the consequences have been awful.”

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