This special supplement is the product of collaboration between the National Institute on Minority Health and Health Disparities (NIMHD) and the Food and Drug Administration (FDA) Office on Minority Health. The goal of this issue is to highlight advances in addressing health disparities and suggest future strategies for the field. The research articles in this issue will inform a larger effort to assess the field and define a vision that will guide the development of the science of eliminating health disparities research for the next decade.
The combined efforts to generate this supplement come at an exciting time when the advent of systems science, large scale databases, and precision medicine lead the paradigm for scientific discovery (http://www.whitehouse.gov/precisionmedicine). Historically, most medical treatments have been designed for the average patient—too often not reflecting the likely diversity and patient mix in the real-world setting. Clinical trials often lack adequate inclusion of diverse groups relevant to the therapy. Thus, label characterization of a medical product’s safety and effectiveness profile may lack sufficient information on key population subgroups. As a result of this one-size-fits-all approach, treatments may be characterized for safety and efficacy for certain patients but not for others. This is changing with the emergence of precision medicine, an innovative approach to disease prevention, early detection, and treatment that takes into account individual differences in people’s genes, environments, and lifestyles.
Precision medicine gives clinicians tools to better understand the complex biological and environmental mechanisms underlying a patient’s health, disease, or condition, and to better predict which treatments will be most effective. As part of its response to a Congressional mandate (http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm389100.htm), the FDA’s recent initiative—the “Drug Trials Snapshots”—provides an unprecedented transparency of demographic subgroup data for new drug approvals (http://www.fda.gov/Drugs/InformationOnDrugs/ucm412998.htm). The National Institutes of Health (NIH) is embarking on a visionary initiative involving teams of experts, to help chart the course for the President’s Precision Medicine Initiative research (http://www.nih.gov/precisionmedicine/index.htm). As part of this effort, the NIH proposes to create a national cohort of at least one million Americans—committed to participate in research—to advance understanding of heath and disease. The national cohort will be unprecedented in scope, and will recruit expertise from multiple sectors to make genomic, environmental, lifestyle, and electronic medical record information available to researchers (http://www.nih.gov/precisionmedicine/whitepapers/Building-Consortium-Cohorts.pdf).
Advances in precision medicine have already led to new discoveries and several new treatments that are tailored to specific characteristics of individuals, such as a person’s genetic makeup, or the genetic profile of an individual tumor. These innovations are leading to a transformation in cancer treatment. Because of these advances, patients with breast, lung, or colorectal cancers, as well as melanomas and leukemia, now routinely undergo molecular testing as part of their disease evaluation and treatment management. These efforts are enabling clinicians to select treatments that can improve survival and reduce possible adverse effects.
The potential for precision medicine to revolutionize care in the development of new treatments has only just begun. Translating these initial successes to a larger scale will require a coordinated and sustained national effort, and must include careful attention to the broader public health impact. Lack of inclusion of ethnic minority and socially disadvantaged population subgroups in this resource-intense era of genomic research and development has the troubling potential to further already existing health disparities. Given the investment of resources and the potential impact on health, it is imperative that future research include diverse populations—moving beyond race to greater precision to the impact of ancestry, sociocultural environment, and genomic adaptation. This will ensure that scientific advances are impactful to all population groups by harnessing innovations in precision medicine to reduce and eventually eliminate health disparities.