Minority groups are severely underrepresented in clinical trials, and the discrepancy poses serious risks for drug safety and patient health.
African-Americans make up 12 percent of the United States population, but they account for only 5 percent of participants in clinical trials, according to a 2011 Food and Drug Administration study. Hispanics make up 16 percent of the population and a mere 1 percent of trial participants.
A new campaign, led by the Pharmaceutical Research and Manufacturers of America, and the National Minority Quality Forum, launches this week to try to narrow this chasm. It will be the first large-scale national effort focused on increasing participation and diversity in clinical trials, and it will focus on furthering connections between physicians, investigators, and patients, particularly in minority populations.
PhRMA President and CEO John Castellani blames "institutional inertia" for why a similar large-scale response to minority underrepresentation hasn't happened earlier.
"We're good at doing what we've always done the same way we've always done it," he says. "But the imperative is, science is changing. The future of medicine is in medicines aimed more and more at genetically homogenous populations, and those populations need to be participating in the discovery process."
Demographic discrepancies are worrisome because clinical trials play a major role in the way drugs and medical treatments are developed, yet genetic differences mean that medications affect different populations in different ways.
Certain diseases — including type 2 diabetes, cardiovascular disease, HIV/AIDS, some types of cancer, and neuropsychiatric illnesses such as schizophrenia and depression — disproportionately affect minority populations, yet the demographics of clinical-trial participants don't reflect the incidences. Thirty-seven percent of new diabetes patients each year are black, compared with 10 percent of diabetes trials participants; 36 percent of patients are Hispanic, compared with 4 percent of participants, according to data from the FDA and the National Institutes of Health.
The danger is that the the population being studied is not the population likely to receive the medication.
"Not having this information, you don't know what you don't know," says Dr. Jonca Bull, director of FDA's Office of Minority Health. "So you would be faced with an inadequate characterization of the product's safety and efficacy profile. Everyone loses when you don't have this information, because the population characteristics are absolutely critical to ensuring that the health care provider has the information they need to make a well-guided decision as to whether a particular medical product is appropriate for their individual patient."
Appropriate medications and dosages can vary by population. Recent research indicates that certain cancer treatments may have significantly higher toxicity in Asian patients than Caucasian patients. Evidence has also found ethnic variations in drug metabolism and toxicity of immunosuppressant drugs, cardiovascular medications, and others.
Advocates of increased diversity cite historic distrust in clinical trials and lack of awareness as the major cause of the discrepancy. Participation in clinical trials overall is quite low, with only about 10 percent of Americans having participated in one, yet the demographic discrepancy is of particular concern.
"In most cases within communities, there's not awareness of clinical trials or understanding of why they take place," says Dr. Salvatore Alesci, vice president of Scientific and Regulatory Affairs at PhRMA, who is involved in the campaign. "This is as much an issue among patients as among physicians."
A Research!America survey in 2013 asked whether groups would be willing to share personal health information to further medical research, and 78 percent of Asians said yes, as did 76 percent of Hispanics, 75 percent of non-Hispanic whites, and 72 percent of African-Americans. On how important the opportunity to improve the health of others would be in deciding whether to participate in a clinical trial, 62 percent of African-Americans said very, along with 57 percent of Hispanics, 50 percent of Asians, and 49 percent of non-Hispanic whites.
Yet the percentage that said they or a family member had participated in a trial was below 20 percent across all groups.
PhRMA and NMQF take these findings to indicate a willingness on the part of these groups to participate, with the barrier being lack of communication and access. Their "I'm In" campaign involves educational outreach and events with both patients and providers, as well as an online database where individuals can register to be connected with relevant clinical trials in their area.
According to Alesci, the focus of more in-depth initial pilot programs will be in southern Texas and Florida, with a particular emphasis on the Hispanic population; Atlanta for African-Americans; and San Francisco for Asian Americans.