Diversity in Clinical Trials
The development of new medicines is a lengthy, complex process that would not be possible without the patients who volunteer to participate in clinical trials to evaluate potential therapies for safety and effectiveness. For trial results to apply to all patients, the demographic mix of patient volunteers must mirror that of the U.S. population. If FDA approves the medicines, they will be prescribed for people of different ages, genders, races, and ethnicities, so it is essential that data reflect the effectiveness and potential side effects for all groups.
However, African Americans, Latinos, Asians, and others are significantly underrepresented in clinical research in the U.S. According to U.S. Census data, Black or African Americans represent 13.4 percent of the U.S. population, yet FDA reports that those populations make up only 5 percent of clinical trial participants. The disparity is even greater for those of Hispanic or Latino origin. They represent 18.1 percent of the U.S. population but only 1 percent of clinical trial participants.
Studies show significant variations in how some diseases and medications affect populations. For example, the blood thinner Plavix is less effective at preventing blood clots in African-American patients with stents because African-American patients metabolize CYP enzymes differently. Findings are similar for Coumadin, another blood thinner. In African Americans with heart failure, the vasodilator Bidil proved more effective than ACE inhibitors and resulted in fewer adverse reactions. If more African Americans participated in clinical research, such drug reactions would be discovered and reported during clinical trials. Instead, the differences in disease and medication response often don’t become known until after a drug is approved and in widespread use.
Identifying and removing barriers to participation
Clinical Research Pathways seeks to increase diversity in clinical research by removing barriers to minority recruitment and participation. The first step is to improve awareness of clinical trials among minority populations and open access. Research indicates that physicians can play a key role in such efforts. Studies show that:
- Patients are more likely to enroll in clinical trials at the recommendation of their healthcare provider.
- Minorities are willing to participate in clinical trials but are not asked to participate as often as White patients.
- When the quality of care is equivalent, patients prefer physicians of the same ethnicity or race as
- Historically, minority providers have not participated in clinical trials at the same rate as nonminority providers. Minority providers are less likely to be recruited and to have experience as clinical investigators.
Clinical Research Pathways has developed an innovative program—Training Minority Clinical Teams: Getting New Quality Medicines to All Americans—that tackles all of these obstacles.
Reaching out to minority patients at the point of care
Clinical Research Pathways launched our Training Minority Clinical Teams: Getting New Quality Medicines to All Americans program in 2018 with a three-year grant ($200,000 for the first year) to Morehouse School of Medicine (MSM) in Georgia, where 31.7 percent of the population is African American and 9.4 percent is Latino. The program acknowledges the singular role of minority healthcare providers and helps equip them to recruit and enroll minority patients in appropriate clinical trials at the point of care. Because the invitation to enroll will come from a trusted provider in a familiar location, the patient may be more likely to participate.
MSM is the ideal partner for this program. MSM has a national reputation as a leader in the creation and advancement of health equity and as a culturally competent community partner. Its Community Physicians’ Network includes 133 physicians who work to eliminate healthcare disparities. Together, the physicians have over 460,000 patients, and at least 30 percent of patients in each practice are minorities. This network presents significant opportunities to recruit both minority physicians and patients.
For the first year, the program will concentrate on cardiovascular disease. The leading cause of death worldwide, cardiovascular disease presents even higher risk for African Americans and Latinos. Therefore, initial recruitment, training, and mentoring efforts will target primary care physicians and cardiologists. In subsequent years, the project will be expanded to include other significant treatment areas, such as cancer, arthritis, and neuroscience.
A pathway to improved public health
Longer term, Clinical Research Pathways intends to expand our Training Minority Clinical Teams: Getting New Quality Medicines to All Americans program nationwide. We will reach out to potential partners that serve African-American and Latino patient populations. We also will work with major research institutions, including MSM, to develop and share practices for recruiting patients from underrepresented populations to participate in clinical trials.
The benefits of increased diversity in clinical research are considerable. Enrolling minority patients in clinical trials improves the likelihood that they will benefit from research discoveries. Trial results will be more representative and, therefore, more relevant for all segments of the population. In addition, studies suggest that increasing access to clinical trials also improves access to healthcare services in general. That, in turn, will lead to better medicines and health equity for all.