In our current age of medicine, we often tout the benefits of evidence-based medicine for our patients: better outcomes with fewer unneeded interventions. However, even the name of this approach depends upon the nature of the evidence, which then leads to the question: Who are we studying?
Acknowledging the disparities in federally funded clinical trials, the United States Congress passed the NIH Revitalization Act in 1993 to provide guidelines for the inclusion of women and minority groups, which was then amended in 2001. Despite some improvement since this measure, we still see relatively fewer minority individuals in clinical studies. As an Asian-American medical student, I often noticed my ethnic group missing from data reported in our lectures. If racial designations were provided, we would often see White/Caucasian and Black/African-American data first before expecting Hispanic/Latino and then Asian-American/Pacific Islander and Native American. This difference in available evidence could have a significant impact on the diverse individuals who make up our patient populations. For instance, without specific research into the ethnic differences in cardiovascular medications, we would not now be familiar with the differing effects of drugs like ACE inhibitors and hydralazine on black versus white patients.
Courtesy of wenzday through Creative Commons attribution 2.0
Underrepresented minority populations, especially black Americans, have had many reasons to doubt the medical community, hearkening back to the Tuskegee syphilis study and many other historical injustices. While this distrust persists to some degree, it is not enough to fully explain the lack of participation in clinical trials. In fact, the consent rates of African-American, Hispanic, and non-Hispanic whites to participate in clinical research may not be significantly different from one another. The number of individuals from each group who are invited to participate, however, continues to be disproportionate. Here, one can then contemplate the deficiencies in recruiting participants and facilitating their access to studies. In addition to advertising clinical trials to a diverse array of individuals, researchers could also reduce their subjects’ barriers to care by choosing nearby research sites and providing or reimbursing transportation.
Even with future improvement in racial representation in clinical studies, our next challenge comes with the appropriate interpretation of these data. Some may assume that this stratification by ethnic groups implies biological differences, but race, after all, is a designation that encompasses many complex physical, social, and cultural factors without discrete boundaries. The astute clinician would remember the socioeconomic conditions that vary between different minority groups and how those may have an even more significant effect than biology.
While we work towards improving representation of all individuals in medical research to be truly generalizable to the population at large, we also live in a time when we are developing the technology to personalize medicine as never before. Since the successful sequencing of “the” human genome, several groups have been working on human genome diversity projects to sample enough genomes to represent our genetic variability. This certainly comes with the ethical dilemma of judging what is correct or healthy based on pure biology, but it also opens up new opportunities for diversity research. As we discover genes and their variants, we will require more inclusive data to determine the purpose of these findings and how we can use them in medicine. With some effort on our part as health providers and the acceleration of scientific findings, we can ensure that evidence-based medicine is founded upon evidence that can benefit all of our patients.
- Chen MS, Lara PN, Dang JHT, Paterniti DA, Kelly K. Twenty Years Post-NIH Revitalization Act: Renewing the Case for Enhancing Minority Participation in Cancer Clinical Trials. Cancer. 2014;120(0 7):1091-1096. doi:10.1002/cncr.28575
- Cavalli-Sforza LL, et al. The Human Genome Diversity Project: past, present, and future. Nat Rev Genet. 2005;6:333-340. doi:10.1038/nrg1596
- Mallick S, et al. The Simons Genome Diversity Project: 300 genomes from 142 diverse populations. Nature. 2016;538:201-206. doi:10.1038/nature18964
- NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research – Amended, October, 2001. National Institutes of Health. October 1, 2001. https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. Accessed November 12, 2017.
- Jacewicz N. Why Are Health Studies So White? The Atlantic. June 16, 2016. https://www.theatlantic.com/health/archive/2016/06/why-are-health-studies-so-white/487046. Accessed November 12, 2017.
- Oh SS, et al. Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled. PLOS Med. 2015;12:e1001918. doi:10.1371/journal.pmed.1001918
- Wendler D. Are Racial and Ethnic Minorities Less Willing to Participate in Health Research? PLOS Med. 2005;3(2):319. doi:10.1371/journal.pmed.0030019
Sophie Sun is a medical student at The University of Arizona College of Medicine – Phoenix, class of 2018. She completed her undergraduate degree at UC Berkeley and earned a PhD in chemical biology from The Scripps Research Institute, where she focused on unnatural amino acid incorporation and antibody engineering. Some of her current academic interests include student-run free clinics, vaccine compliance, and accountability in research. However, she might sound more excited when talking to you about classic American cinema, urban compost collection, and French dessert recipes. She is currently pursuing a career as a Med-Peds physician.