Clinical trials are at the heart of the process for bringing new medicines to patients. While modern researchers can do more with molecules in the laboratory than ever before, and preclinical analysis of a compound can provide important evidence about its potential value in treating disease, it’s impossible to determine the safety and effectiveness of a new medicine until it’s tested in human beings.
Critical to the conduct of any clinical trial is identifying the right group of people to include in the study. Unfortunately, most of the clinical trials conducted in this country suffer from a pronounced lack of diversity. Minority populations are consistently underrepresented. And, too often, there is a lack of appreciation of cultural and genetic factors particular to Asian, African-American, Hispanic, and other ethnic communities. This diversity gap can lead to sub-optimal development of new medicines and can further exacerbate minority health disparities.
According to the Food and Drug Administration, while African-Americans represent 12 percent of the total U.S. population, they comprise just 5 percent of clinical trial participants. Hispanics account for 16 percent of the total population but just 1 percent in trials.
A new study from the University of California at Davis shows that, despite a Congressional mandate that research financed by the National Institutes of Health include minorities, non-whites comprise fewer than 5 percent of participants in NIH-supported studies.
The numbers are even worse when you look at clinical trials aimed at diseases disproportionately affecting minority communities.
African-American men are twice as likely as their white counterparts to die from prostate cancer. Yet they represent just 4 percent of prostate cancer clinical trial participants. Suicide is one of the top three causes of death among Asian-American women under 45 years of age; this cohort constitutes just 1 percent of trials for potential treatments for major depressive disorder. And while the prevalence of diabetes among Mexican-Americans and Puerto Ricans is more than double that of Caucasians, those groups combined represent just 4 percent of diabetes trial patients.
This diversity problem can have serious consequences. The effectiveness of a given medicine can vary depending on a patient’s ethnicity, lifestyle, culture, and genetic makeup. Certain blood pressure drugs, for instance, simply don’t work for many African-Americans.
When participant pools for clinical trials are skewed towards Caucasians, researchers risk missing key drug-gene interactions. And they certainly don’t get the data needed to customize treatments for diseases disproportionately affecting minority populations.
Trial diversity has become even more important with the emergence of personalized medicines. Breakthrough research techniques are making it increasingly possible for drug developers to tailor pharmaceutical agents for a patient’s genetic profile. But effective tailoring depends on harvesting an array of underlying data from human testing.
There are a variety of reasons for the low rate of clinical participation among ethnic communities. Some are distrustful of clinical trials or understandably wary of sharing the most intimate details of their health in a clinical trial setting. Many simply haven’t learned about the vital role these trials play in creating new treatments and cures.
There can be other practical matters that interfere. Sometimes trial materials haven’t been translated into someone’s native language or are insufficiently sensitive to their religious beliefs. Transportation to and from clinical sites can be prohibitively expensive for some potential participants. Others can’t afford to miss work.
The pharmaceutical industry recognizes that these issues can and must be addressed and is playing a lead role in forging solutions.
Recently, the Pharmaceutical Research and Manufacturers of America (PhRMA) has teamed up the National Minority Quality Forum to launch “I’m In,” a national education program designed to engage underrepresented participant populations and communicate the value of clinical trials. “I’m In” identifies and connects with prominent local figures and care providers to encourage patients to enroll.
Lilly has launched a first-of-its-kind program to train, mentor and equip minority investigators to conduct clinical trials that are well-designed and relevant to minority populations. For example, we have found that people are much more likely to volunteer for a trial if their contact person is familiar with their culture.
That’s why our program draws directly from communities that are currently underrepresented. Investigators in the program speak the right language – figuratively and often also literally. Since we increased efforts to enroll minorities in clinical trials in 2008, Lilly has initiated more than 400 new minority clinical trial sites nationwide.
These steps will help us to more effectively develop medicines, to diminish minority health disparities and to achieve a stronger overall public health benefit. But in order to close the diversity gap, we need more companies and public agencies to throw their weight behind initiatives like these. Increasing minority participation in clinical trials should be a top priority throughout the health care system.
