Drug Trials Suffer From Little Diversity

April 3, 2008 — -- A generation of baby boomers is approaching retirement and Americans are living longer. But elderly people are routinely left out of clinical drug trials that determine how people react to medications, according to a new report.

The report released this week by Houston's Baylor College of Medicine and the Intercultural Cancer Council found that studies focused on drugs for diseases affecting the elderly -- whether Alzheimer's, arthritis or cancer -- are conducted without much participation from older Americans.

"Most clinical trials don't recruit elderly people," said Dr. Barbara Pence, professor of pathology at Texas Tech University's Health Science Center. "We really have no idea, in terms of well-designed clinical research, how well these drugs are tolerated and how effective they are in elderly populations."

The report revealed that elderly people were not the only ones left out. Women, people of color, the disabled and those living in rural areas are also under-represented in clinical trials, according to the two-year assessment of records. The analysis found that of the estimated 80,000 clinical trials conducted each year nationwide, less than 1 percent of the country's population takes part.

"We are not exactly doing the most accurate job of treating the diversity that we see," Pence said.

Cancer drug tests were one area in which that apparent lack of diversity stood out.

The report concluded that 25 percent of people participating in 2003 cancer studies were older than 65, despite the fact that about two-thirds of cancer patients are older Americans. One study found that fewer than 10 percent of patients involved in research on new cancer drugs between 1995 and 1999 were African American, Asian/Pacific Islanders, Hispanics or Native Americans.

"Frankly, some of the work that we've seen, there are a number of barriers," said Dr. Armin Weinberg, the report's principal investigator and professor of medicine at Baylor College of Medicine. "What we've found is that there's something almost everybody could do to help eliminate these disparities."

Whether because of a mistrust of medical research, trouble completing long and complicated consent forms or the absence of referrals by their doctors, many people do not participate in clinical trials. Many simply don't meet the strict criteria required to take part.

To improve access to clinical trials, the report's recommendations included simplifying consent forms, providing new incentives for diversifying pharmaceutical industry trial and mandating stricter criteria for who is and isn't eligible to take part.

It called on the U.S. Food and Drug Administration to require that researchers include under-represented populations in all clinical trials. The National Institutes of Health requires that women and people of color be included but the FDA does not have the same requirements.

On Tuesday, the FDA stopped short of embracing the idea of participation quotas but said agency guidance documents encourage companies to study "a reasonably representative sample of the intended population."

The "FDA currently encourages inclusion of diverse populations in drug development, but does not mandate specific numbers of individuals representing demographic subgroups," FDA spokesman Christopher DiFrancesco said in a statement.

He added that requiring specific numbers of racial or ethnic groups to participate would "result in a massive increase in the size of such trials" and said the benefits of inclusion would "be outweighed by the burdens in terms or cost of drug development and delays in access to therapy."

"We don't think it's going to add time or cost," said Dr. James Powell, principal investigator of the National Medical Association's project to increase minority participation in clinical trials. "It'll give the researchers an opportunity to recruit patients that have not been a part of the process."