The continuing under-representation of minority populations in clinical studies is depriving some of the most vulnerable people in the US of better tailored treatment options, the founder of a trial search website warns.
This year the National Partnership for Action to End Health Disparities reported that minorities in the US “live sicker and die younger”, with a significantly higher prevalence of chronic disease, notes Dr Bruce Moskowitz, founder of MyClinicalTrialLocator.com, in an Op-Ed article for LiveScience.
Yet Hispanics, for example, make up more than 16% of the overall US population while accounting for only 1% of clinical-trial participants.
“It is important to increase the diversity of clinical-trial participants because there is growing evidence that gender and ethnicity play important roles in healthcare outcomes,” writes Moskowitz, who is also chairman of the board of the Biomedical Research and Education Foundation.
“Not only are certain groups at higher risk for specific diseases, but race and ethnicity play a role in how patients respond to drugs.”
These disparities in representation are despite efforts by the US Food and Drug Administration (FDA) and the National Institutes of Health to encourage clinical-trial data that more accurately reflect real-world diversity, Moskowitz points out.
This summer marks the first anniversary of the FDA Safety and Innovation Act (FDASIA) becoming law.
Under FDASIA, the US drug agency must report to Congress by 9 July 2013 on the diversity of participants in clinical trials, and the extent to which safety and effectiveness data based on such factors as sex, age, race and ethnicity are included in applications filed with the FDA.
There is lingering mistrust among minorities of the system that conducted the notorious Tuskegee syphilis experiments on rural black men from 1932 to 1972, Moskowitz suggests.
Other obstacles include lack of insurance; low awareness of clinical-trial treatment options; language and health-literacy barriers to an often complex informed-consent process; eligibility criteria that exclude minority patients with multiple health problems; and practical concerns such as the cost of travel, lack of childcare and missing work.
All the same, a recent Research!America survey found that more than 72% of Americans were willing to take part in a clinical trial if their doctor recommended one, Moskowitz observes.
Capitalising on this positive sentiment means raising awareness that clinical trials can extend or save lives, he says.
“But to succeed in this effort, we need more ethnic diversity among physicians and researchers, and partnerships with community health centres.”
When more people, and more diverse populations, participate in clinical trials, “everyone stands to benefit”, Moskowitz insists.