WHY WE NEED ETHNIC DIVERSITY IN MEDICAL RESEARCH
by, Victor Chin, MD
Imagine you are being treated for cancer with a chemotherapeutic drug. You assume the drug is approved by the U.S. Food and Drug Administration (FDA) to be safe and effective for your particular cancer condition based upon results from medical research trials. Did you know if you are a person of color your cancer drug may have never been tested in your unique ethnic or racial group? In essence, you could be an unwitting participant in an unregistered medical experiment.
MINORITIES ARE UNDERREPRESENTED IN RESEARCH STUDIES:
Cancer specialist Dr. Jonathan Loree and colleagues in the August 15, 2019 edition of Journal of the American Medical Association Oncology reviewed 230 cancer drug trials conducted from 2008-2018 that involved over 112,293 participants. Only 7.8% of the 230 studies documented participants from the 4 major races in the United States (white, Hispanic, black, Asian). The percentage of trials including participants from different racial groups did not change significantly over the 10 year period. The percentage of Hispanic and black participants in the cancer studies was far lower than the proportion of Hispanic and black patients who would have disease in the general population. The burden of disease among minority groups was not addressed in the makeup of participants in cancer research studies.
THE EFFICACY OF A MEDICATION CAN VARY IN DIFFERENT RACIAL GROUPS:
Why is it important to study medications in various racial/ethnic populations? A particular medication’s efficacy may vary depending on the patient population. For example, current guidelines from the American Heart Association recommend that for treatment of hypertension in black patients a physician starts with a thiazide-type diuretic or a calcium channel blocker. In research studies, these medications have shown relative greater efficacy in blacks for hypertension as opposed to an angiotensin converting enzyme (ACE) inhibitor, which is often used first-line in other patients.
THE ARGUMENT FOR SOCIAL JUSTICE IN MEDICAL RESEARCH:
Numerous advocates raise the issue of social justice in medicine – the idea that racial group disparities in the delivery of healthcare and outcomes in health should be eliminated. The inclusion of people of color in medical research is crucial to improving health for all people in our society. The FDA has recognized the importance of diversity in medical research and in 2016 issued a non-legally-binding guidance statement encouraging study sponsors to include more racially/ethnically di- verse participants in trials:
“FDA expectations are that sponsors enroll participants who reflect the demographics for clinically relevant populations with regard to age, gender, race, and ethnicity.” In June 2019 the FDA released a new draft guidance statement furthering its encouragement of diversity in medical research in which it stated:
“Broadening eligibility criteria and adopting more inclusive enrollment practices will open clinical trials to a diverse participant population reflective of the population that will use the drug if the drug is approved.”
Personalized healthcare and medicine have brought this issue front and center. The keyword here is ‘personal’ which for me involves the reality that every male on my biological father’s side of the family died from cancer. The fact that I have sons that may be affected by the lack of racial diversity in medical research hits home. I could no longer be a bystander when witnessing the lack of ethnic diversity in both genomic research and clinical trials. I thought that if government and policy makers will not address this form of health disparity and health inequality, then it is up to me to intervene and make a positive impact. I want to ensure the treatments of the future apply to people of color.”
-Delmonize “Del” Smith, founder and CEO of Acclinate Genetics explaining his inspiration to diversify medical research.
A CALL TO ACTION FROM ACCLINATE GENETICS:
Calls for social justice alone in medicine have resulted in inadequate results. It is time to utilize the unique problem-solving abilities of the world of business to reduce racial differences in health.
More than just a headhunter to match people of color to medical trials, Acclinate Genetics aims to build and maintain relationships with college graduates of color. Acclinate Genetics serves as a liaison between the medical research industry and well-educated patients of color by vetting research opportunities and educating its participants about medical research. Acclinate Genetics strives to bridge the lack of trust many minority patients have in the medical research system.
By having well-educated active participants of color in research trials, pharmaceutical companies can produce better quality research trials with fewer patients lost to follow-up. By testing in a diverse population, unique efficacies/toxicities of drugs may be found in specific racial/ ethnic groups that would go undiscovered if only a white male study population were used.
601 Genome Way Huntsville, AL 35806 acclinategenetics.com