July 25, 2011 (Washington, DC) — Minority participation in clinical trials has not improved over the past several decades, one researcher declared here at the National Medical Association (NMA) 2011 Annual Convention and Scientific Assembly. The shortage of minority participants and researchers continues despite arguments made in the medical community that minorities should be included to identify disparate reactions and disparities in healthcare.

When Kwame Osei, MD, started investigating the racial and ethnic differences in diabetes and obesity at Ohio State University in Columbus in the 1980s, he was told that minority participation in clinical trials would increase as more trials looked at health disparities and other areas of interest to minority health.

“They told me ‘If you build it, they will come,’” Dr. Osei told the audience. today. “Well, that hasn’t happened.”

Thirty years later, minority participation in clinical trials remains lower than in the general population. According to Dr. Osei, minorities make up only 10% of participants in multicenter clinical trials.

Dr. Osei was 1 of 9 experts who spoke on “Increasing Diversity in Clinical Research,” put together by the NMA’s Project IMPACT (Increase Minority Participation and Awareness of Clinical Trials).

Although many people are quick to attribute the lack of participation to mistrust of the medical system and large institutions, James H. Powell, MD, principal investigator for Project IMPACT, says that’s only part of the story. “People don’t know how important [diversity in clinical research] is,” he says. He points to recent withdrawals of certain drugs from the market and wonders if perhaps the adverse effects seen after release have anything to do with how different populations and subpopulations respond to different medications.

“We’ve sold people on the idea of personalized medicine,” he says. “But first we have to understand persons and the diversity of people. It’s hard to say we have the right drug for a particular person if we haven’t tested the drug in that population.”

The National Institutes of Health (NIH) is also concerned about the lack of minority representation among clinical investigators. According to John Gallin, MD, director of the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, who also spoke at the conference, the NIH will release a report from the NIH Taskforce for the Inclusion of Women and Minorities in Clinical Research. He says the report will reiterate and elaborate on NIH’s commitment to increasing diversity in clinical trials among participants and investigators. The goal will be for all trials to include women and minorities to allow for valid analysis of any potential differences in efficacy or safety in different populations. It also calls for the initiation of outreach efforts.

Dr. Gallin also said that NIH is redesigning training programs for clinical investigators to ensure that physicians of all backgrounds have the opportunity to pursue an interest in clinical research. These programs include the NIH Clinical Research Training Program, a newly designed NIH Medical Research Scholars Program, and the new Lasker Clinical Research Scholars Program.

For physicians further in their careers, NIH offers sabbatical programs at the Clinical Center and the Bench-to-Bedside program, which includes special funding for minority health issues and health disparities, such as sickle cell disease, obesity, and diabetes.

In the sessions’ post-test, participants were asked whether diversity in clinical research is a social justice issue. About half answered “yes.” Dr. Powell responded, “It is a social justice issue but it’s a medical and a scientific issue as well.”

Lack of minority participants in clinical trials contributes to health disparities and inhibits medical discovery, he explained: “When we discover differences, and we investigate the basis of those differences, it develops whole new lines of discovery.”

Drs. Osei and Gallin have disclosed no relevant financial relationships. Dr. Powell is a stock holder in Procter & Gamble and a consultant to Pharmaceutical Research and Manufacturers of America.

National Medical Association (NMA) 2011 Annual Convention and Scientific Assembly. Project IMPACT session: a combined session with the Internal Medicine Section. Presented July 25, 2011.