Many U.S. Clinical Trials Underrepresent Certain Populations, Including Minorities, Study Finds

Many clinical trials conducted in the U.S. exclude or underrepresent participants from numerous populations, including women, people over age 65, the disabled, rural residents and minorities, according to a report released on Tuesday, HealthDay/U.S. News & World Report reports (Mozes, HealthDay/U.S. News & World Report, 4/1). The report, "Eliminating Disparities in Clinical Trials," was conducted by Baylor University College of Medicine's Chronic Disease Prevention and Control Research Center and the Intercultural Cancer Council (Cooley, CQ HealthBeat, 4/1). Genentech funded the study through an "unrestricted educational grant," HealthDay/U.S. News & World Report reports.

For the study, lead researcher Armin Weinberg, chief policy analyst Daniel Goldberg and a team of more than 300 analysts over four years reviewed policy positions held by public, private and not-for-profit clinical trial sponsors in the U.S. About 80,000 clinical trials are conducted annually, and about 2.3 million people -- less than 1% of the U.S. population -- participate in such trials, according to the report.

Researchers found that between 1995 and 1999, blacks, Asian-American/Pacific Islanders, Hispanics and American Indians together accounted for less than 10% of patients included in new cancer drug trials. The lack of representation of minority and other populations could lead to results that do not represent cultural, racial, religious, linguistic, age and gender differences that could impact the efficacy of drugs in the general population, researchers said (HealthDay/U.S. News & World Report, 4/1). Weinberg said, "Even if we've managed to see some increases in certain areas of numbers of participants in clinical trials ... we have not seen the proportion of minorities increase" cite>CQ HealthBeat, 4/1).

The report includes a list of recommendations to address the disparities, including the suggestion that NIH provide detailed instructions "on appropriate inclusion plans for underrepresented populations" in clinical trials ("Eliminating Disparities in Clinical Trials," (.pdf) 4/1). The report also recommends that researchers establish more community outreach efforts, such as "navigation programs" to guide participants and encourage retention, and build a rapport with underserved communities to establish trust (CQ HealthBeat, 4/1). Other recommendations include more oversight from scientific journals of participant demographics and to guarantee insurance coverage for all costs related to trial participation (HealthDay/U.S. News & World Report, 4/1).

FDA, Industry Reaction
FDA currently recommends that clinical trials include diverse populations but has no mandate on the minimum number of participants from those populations, according to CQ HealthBeat. FDA spokesperson Susan Cruzan said in a statement that a minimum inclusion mandate "would result in a massive increase in the size of such trials," adding, "It would be likely that the benefits of setting subgroup quotas to obtain increased knowledge about subgroup responses to drugs would be outweighed by the burdens in terms of cost or drug development and delays in access to therapy." Cruzan said, "The vast majority of drugs appear to behave similarly in all humans and do not show subgroup differences." Meanwhile, industry representatives contend that a minimum inclusion mandate would slow the innovation process, CQ HealthBeat reports (CQ HealthBeat, 4/1).