Why All Stakeholders Must OWN The Mission
It has been 25 years since Congress passed the National Institutes of Health Revitalization Act requiring federally funded clinical research programs to prioritize inclusion of women and minorities. Since then, both the NIH and the Food and Drug Administration have mounted numerous initiatives, including regulatory guidance aimed at shoring up the law’s intent.
Despite parallel efforts by biopharmaceutical innovators, the demographics of clinical trials today still do not reflect the racial, ethnic or gender diversity of target patient populations around the world. This is true for trial subjects, of whom an estimated 83 percent are white. And it’s true for the race/ethnicity/gender representation of investigators at many trial sites as well.
As of 2018, some 78 percent of individuals included in genome-wide association studies were of European descent, while those of African or Hispanic ancestry made up just 2 percent and 1 percent, respectively, according to a report in the journal Cell. The bias in the data harms our understanding of genetic and environmental causes of disease and impedes both individualized and population-wide efforts in prevention and treatment.
Many experts worry that population trends will magnify the negative impact of racial/ethnic imbalances in clinical research. After all, in the U.S., the percentage of minority participants in studies rarely exceeds low double digits at a time when racial and ethnic minorities make up nearly 40 percent of the population overall. The picture will be more complex as we move beyond the year 2045, a crossover point when Caucasians will comprise just less than half (49.7 percent) of the U.S. population.
“Future population shifts will magnify the negative impact of disparity in our clinical research—with grave implications for precision medicine,” says Syneos Health Behavioral Scientist Kathleen Starr, who, in June 2019, chaired a panel exploring both the causes and potential corrective approaches to research disparities at the BIO International Convention in Philadelphia. In short, the panel warned that translational relevance of biomedical research will shrink over time unless societies address intrinsic bias issues as results are generalized from a white European subject base.
There is, however, good news: Even as the challenges persist, education and outreach efforts by agencies, industry organizations, patient groups and private companies are accelerating. The strong consensus among all these stakeholders is that, by tackling these issues today, we can build for the 21st century.
The report that follows will describe some of the strategies different stakeholders employ to address a diversity deficit, along with their insights and experiences on the front lines of this endeavor.