April is Minority Health Month, which gives everyone in clinical research a chance to review the importance of including minorities in our medical trials. In the past weeks representatives of the National Institutes of Health, the FDA, NGOs, and pharmaceutical companies all have contributed to the conversation. And on April 28, the NIH appointed a new Director for its National Institute on Minority Health Disparities.
Under-representation is a challenge in clinical trials
The under-representation of ethnic minorities in clinical trials presents an ongoing challenge. Centers for Disease Control (CDC) reports on the incidence of cancer show that rates of the disease are dropping overall, but that some ethnic groups still are affected disproportionately. A 2014 article in Cancer also provided some insight:
- African Americans have the highest incidence rates and the highest mortality rates in cancers of the prostate, the lungs, the colon and rectum, the pancreas, the esophagus, and the kidneys
- African Americans have the highest mortality rates of breast cancer
- Native Americans have the highest incidence of kidney cancer and the highest mortality rates for lung cancer
- Cancer is the leading cause of death for Asian Americans and for Latinos
That same article found that since 1996 the proportion of minorities participating in oncology studies has decreased. In 1996, 3.7% of cancer study participants were African American; by 2012, that number was 3%. For Hispanics, the drop was sharper, from 11% to 7.9%. As the article concluded, “the proportion of racial/ethnic minorities participating in cancer clinical trials is persistently lower than the proportion of minorities in the US population at large (36.3%) and minorities remain disproportionately burdened with cancer and under-representation in cancer clinical trial enrollments.”
That quote captures the cultural, scientific, and human consequences of under-representing minorities in research. The cultural consequence: not all of our citizens realize equal health opportunities; the scientific consequence: a study cohort that does not reflect the population; and the human consequence: people suffering from a disease may miss opportunities for improvement, or may undergo treatment that is inappropriate for them.
While these statistics focus on cancer, other diseases have similar patterns, and some organizations are working on changing things. The FDA has launched its Action Plan for minorities and established an Office of Minority Health. The pharmaceutical group PhRMA has teamed with the Minority Quality Forum to launch the I’m In program.
An interview with Dr. Owen Garrick
Dr. Owen Garrick works with Bridge Clinical Research, a California contract research organization (CRO) dedicated to bringing minority representation to more clinical trials. Dr. Garrick also served on Quorum’s IRB, and we recently corresponded about Bridge Clinical Research and the challenges of minority representation in clinical trials.
Q: How did Bridge Clinical Research start, and how did you become involved with it?
A: The predecessor company was started by a urologist in New York City who had been doing studies in BPH and prostate cancer. At investigators meetings he noticed he often was the only Black Principal Investigator (PI) in a therapeutic area where Black men were overburdened from a disease perspective. He formed the original company as a result and I served on his advisory board.
Q: What particular challenges and rewards have you found pursuing Bridge Clinical’s mission of uniting minority populations with clinical trials?
A: We have been excited to find that there is an unmet demand by both minority investigators and subjects to participate in clinical trials. One of the key challenges is getting sponsors to take on minority investigators who are often naive and have less research infrastructure than some of their non-minority peers.
Q: In 2013, researchers tracked down a sampling of people who had considered participating in a clinical trial. The researchers found that African Americans were almost twice as likely not to join a study as whites. Does that seem consistent with your CRO’s experience?
A: Most of the published literature and our experience show similar rates of participation and willingness to participate in clinical trials among ethnic groups. Some things to consider with the above sampling is the complexity of the protocol, the ethnicity of the PIs or research coordinators, whether or not the study was conducted in an academic setting versus a private practice and if the recruitment materials included messaging and content that would resonate.
Q: What would you suggest to someone at a site, a research institution, a pharmaceutical company, or an IRB who wants to recruit and engage more minorities in clinical research?
A: There is a real opportunity to improve minority health as more minorities participate in clinical trials and we learn if potential new medications are effective in those populations. Also, as the demand to meet study timelines increases, minority populations are a ready source of available and willing research participants.
Q: Some of these statistics paint a rather bleak picture. Have you seen any positive trends or developments?
A: We have certainly seen much more public discourse about the importance of minority participation in clinical trials. We have also seen a few examples of minority investigator research networks develop. From a tactical perspective, it would be great to begin to change the numbers in say one therapeutic area. We could use that success to turn the overall tide.
And agency efforts such as the FDA’s Office of Minority Health also represent a positive trend. The OMH was created in 2010 as part of the Affordable Care Act, and its new director, Dr. Jonca Bull, is a well-respected researcher.
Minority Health Month focuses our attention on the people who strive to provide everyone with equal health care opportunities. Statistics such as those from the CDC and in the Cancer article show there is still a lot of work to do. But some of the solutions, as with so many health care challenges, can start with the right clinical trial.