The Food and Drug Administration has declared a renewed focus for 2016 exploring diversity in clinical trials.  Data gathered from FDA shows that there is still a significant lack of patient diversity in clinical trials. “While African-Americans/Blacks represent 12% of the total U.S. population, they comprise just 5% of clinical trial participants. Hispanics account for 16% of the total population but just 1% of trial participants.” 
As researchers aim to understand how a drug’s effectiveness can vary in different patient groups, it is important to consider how U.S. demographics have begun dramatically shifting. According to the U.S. Census Bureau’s latest projection “It is predicted that by 2043, the U.S. will be a majority non-white nation.  White Americans will have gone from comprising 85% of the U.S. population in 2012 to just 43%. Hispanic and African Americans/Blacks will have grown substantially over that period, together making up 45 percent of the population with Hispanics being one of the fastest growing groups making up 31%.” Therefore the inclusion of minorities in clinical trials will only become more critical. To demonstrate the safety and effectiveness of a new treatment, healthcare industry leaders should ensure the inclusion of a diverse population in clinical trials. Underrepresentation of minorities can skew vital trial and treatment data.
Some causes for lack of diversity and inclusion in clinical trials stem from lack of trust in trials, lack of awareness of what trials are, and barriers to participation of minority population in trials. For example, based on the history of medical research in the Tuskegee study, an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service studying the natural progression of untreated syphilis in rural African-American men in Alabama under the guise of receiving free health care from the United States government, there is a fear of exploitation in medical research. Second, there is often a lack of misunderstanding about the process of clinical trials. Third, there are barriers to participation or feasibility for minority populations to enroll in clinical trial.
To attempt solve these complex diversity and inclusion issues, it is critical to go beyond the current one-size fits all approach and raise awareness, build trust, and reach out to under-represented population. Increased diversity in the population pool of clinical trials might just even result in greater confidence in the results and benefits of drugs to the population.
The Center for Healthcare Innovation’s Diversity, Inclusion, & Life Sciences Symposium on June 22, 2016 will address these issues in-depth. The Symposium is the leading annual, collaborative event for life sciences and healthcare executives, physicians, HR professionals, clinical trial professionals and patients, entrepreneurs, patient groups, researchers, academics, and diversity and inclusion advocates to discuss diversity and inclusion in healthcare. Please visit chisite.org/education/diversity-symposium/ for more information.
- 2016: The Year of Diversity in Clinical Trials | FDA Voice. http://blogs.fda.gov/fdavoice/index.php/2016/01/2016-the-year-of-diversity-in-clinical-trials/.
- Bridging the Diversity Gap in Clinical Trials | Thought leadership and innovation for the Pharmaceutical Industry – EyeforPharma. http://social.eyeforpharma.com/clinical/bridging-diversity-gap-clinical-trials.
- Census: White majority in U.S. gone by 2043 – U.S. News. http://usnews.nbcnews.com/_news/2013/06/13/18934111-census-white-majority-in-us-gone-by-2043.
- A Study On The Changing Racial Makeup Of “The Next America.” http://www.huffingtonpost.com/2014/04/13/changing-racial-makeup-_n_5142462.html.