A new report by the U.S. Food and Drug Administration and the National Alliance for Hispanic Health revealed a lack of diversity in clinical research and personalized medicine, and that such lacking diversity could actually be setting back scientific advances in health care.

"Genes, Culture, and Health: Ensuring the Best Health Outcomes for All," a report prepared by the U.S. Food and Drug Administration and the National Alliance for Hispanic Health, revealed incredible advances made in genetic research and clinical applications.

It also documented the lack of diversity in clinical trials and personalized medicine and revealed how a lack of racial diversity in clinical research undermines scientific efforts.

The report unearthed a number of important findings, but the most important were the topics of inclusion and access. Advancements in genetics-driven personalized medicine depends on diverse research populations to determine the most effective biological therapies and personalized medicines for major ethnic and racial U.S. populations.

Nonetheless, women and non-whites continue to be underrepresented in genetic studies. In fact, only 4 percent of genome-associated studies include individuals of non-European descent. And without diversity in studies, genetic variants significant to the study of disease and therapy response can go undiscovered.

Failure to focus studies on wider audiences can and will result in genomic medicine largely benefiting a privileged few, according to the report. 

There are genetic variants found in less than 5 percent of people, and examining a more diverse population for study could lead to a better understanding of responses to particular therapies and disease risks.

"A lack of inclusion in genetic research is creating a genomic divide putting the frontiers of science and medicine at risk.  Without a dramatic reversal in the quality of genetic studies, the benefits of personalized medicine will not be realized by all," said Dr. Jane L. Delgado, President and CEO of the Alliance, in a statement.

Dr. Jonca Bull, Director of the U.S. Food and Drug Administration's (FDA) Office of Minority Health, praised the findings of the report, calling it "an important update on the status of genetic research and personalized medicine" and noting that the findings call on the medical community to improve on including more ethnic groups in their studies in order to figure out how medical products will work within the public they serve.

"Ensuring that all patients benefit from discoveries in genetic science and personalized medicine is critical to our nation's health. The FDA is committed to working with diverse partners on the road forward for access to the best science and treatment," said Dr. Bull.

The National Alliance for Hispanic Health report established that incorporating multiple demographic groups including sex, age, race and ethnicity could produce better health outcomes for women and non-white populations, and it could likely produce better outcomes in general, leading to the treatment of chronic conditions, disorders, diseases and viruses.

Recommendations for improvements include implementing federal research guidelines for inclusion; launching efforts to use genetic information to advise health decision-making; guaranteeing access to counseling, testing and companion diagnostics; and enhancing quality of care based on knowledge gained from genetic studies.

The process of involving a complex variety of ethnic groups also means eliminating barriers to participation and forcing compliance of regulatory mandates, which are critical to achieving the promise of identifying unique genetic and environmental profiles; offering personalized medicines; and identifying novel or rare functional genetic variants for Hispanics and other unexamined demographic groups.