The ABCs of why Diverse Clinical Trials are Essential
The ABCs of Why Diverse Clinical Trials are Essential
June 2016 | White Paper
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Key Insight
"Diversity in clinical trials is important for 3 reasons: Altruism can ultimately benefit biopharmaceutical companies, better science is important for clinical trials as greater diversity in sample sizes of clinical trials means better data, and changing U.S. demographics are disrupting the healthcare marketplace."
Introduction
A recent story on NPR’s Morning Edition noted that about “40 percent of Americans belong to a racial or ethnic minority, but clinical trial participants tend to be more homogeneous.” Lack of diversity in clinical trials is still a problem, despite that the fact that increased diversity in clinical trials has been on the National Institutes of Health’s (NIH) priority list for almost 30 years.
"For years we have known that it is crucial to incorporate the right group of individuals into studies, as evidence shows that effectiveness of a particular drug can vary depending on a patient's race, ethnicity, gender, and genetic makeup."
For instance, in a study on a drug used for schizophrenia, it was found that one side effect – “the urge to move continuously” – was more common in African- American/Black patients. An- another clinical trial focusing on blood pressure drugs was found to be less effective on African- American/Black patients as compared to Caucasian patients, and another drug used for heart failure is found to be more effective in African- American/Black patients than Caucasians. These examples suggest the importance of making clinical trials more inclusive and diverse, but unfortunately, despite efforts to make trials more diverse, there is a wide gap in patient diversity while conducting clinical trials. "According to the Food and Drug Administration, while African-Americans/Blacks represent 12 percent of the total U.S. population, they comprise just 5 percent of clinical trial participants. Hispanics account for 16 percent of the total population but just 1 percent of trials." And the University of California concluded in a study that, despite a mandate for National Institutes of Health to include a diverse population in their studies, minorities and non-Whites comprise less than 5 percent of participants in NIH- supported research. This is particularly challenging since the lack of diversity can substantially overshadow the bio- pharmaceutical industry's vital role in developing medications for the benefit of all communities.
This research report will explore diversity and inclusion in clinical trials to help biopharmaceutical organizations understand the importance of making clinical trials more diverse. The biopharmaceutical industry can bring value to their businesses as well as the community by understanding the ABC’s of why diversity in clinical trials is essential. First “Altruism” (A) can ultimately benefit biopharmaceutical companies. For-profit biopharmaceutical organizations have a responsibility to shareholders, but these organizations are also increasingly understanding that making the world a better place is good for business. More organizations are valuing corporate social responsibility (CSR), as it’s also good for the bottom line, and this is particularly important as biopharmaceutical companies attempt to make the historically exclusive clinical trial ecosystem open to diverse patient populations. Next “Better Science” (B) is important for clinical trials as greater diversity in sample sizes of clinical trials means better data. More diverse samples can show any variations in responses and effectiveness of the drugs concerning differences in race/ethnicity or gender. And it has also been suggested that more diverse data samples can increase the probability of FDA approval. Finally, “Changing U.S. Demographics” (C) indicates that the racial/ethnic minority of the U.S. is rapidly changing, and biopharmaceutical organizations cannot continue taking a “one size fits all” approach to marketing and selection. It’s particularly important to understand cultural variables when branding and marketing to certain groups, as the U.S. is expected to become majority-minority nation by 2043. This report will explore the “ABCs” of diversity in clinical trials, and why it’s important in the 21st century.
Key Statistics and Infographics
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Authors
Dr. James Gillespie, PhD, JD, MPA
President & Co-Founder at CHI
Joseph Gaspero
CEO & Co-Founder at CHI
Mr. Doug Harris
CEO at The Kaleidoscope Group
Ms. Asra Khalid
Senior Analyst at CHI
Joseph Gaspero is the CEO and Co-Founder of CHI. He is a healthcare executive, strategist, and researcher. He co-founded CHI in 2009 to be an independent, objective, and interdisciplinary research and education institute for healthcare. Joseph leads CHI’s research and education initiatives focusing on including patient-driven healthcare, patient engagement, clinical trials, drug pricing, and other pressing healthcare issues. He sets and executes CHI’s strategy, devises marketing tactics, leads fundraising efforts, and manages CHI’s Management team. Joseph is passionate and committed to making healthcare and our world a better place. His leadership stems from a wide array of experiences, including founding and operating several non-profit and for-profit organizations, serving in the U.S. Air Force in support of 2 foreign wars, and deriving expertise from time spent in industries such as healthcare, financial services, and marketing. Joseph’s skills include strategy, management, entrepreneurship, healthcare, clinical trials, diversity & inclusion, life sciences, research, marketing, and finance. He has lived in six countries, traveled to over 30 more, and speaks 3 languages, all which help him view business strategy through the prism of a global, interconnected 21st century. Joseph has a B.S. in Finance from the University of Illinois at Chicago. When he’s not immersed in his work at CHI, he spends his time snowboarding backcountry, skydiving, mountain biking, volunteering, engaging in MMA, and rock climbing.