Diversity in Clinical Trials

Minority populations have historically and consistently been underrepresented in clinical trials. As a result, important information about how medicines work in minority populations is not always available.

This issue is critical because patients’ responses to medicines can vary by ethnicity, lifestyle, and genetic background. For example, African Americans and Hispanics are 2.2 times and 1.6 times more likely, respectively, to die from diabetes than non-Hispanic whites[1], yet combined they have historically represented only 15 percent of diabetes clinical trial participants[2].

More diverse representation in clinical trials is needed to gain insights that will make medicines most effective for all people who use them. Across the industry, pharmaceutical companies are aiming to better match the demographic composition of clinical test groups with the disease-prevalence rate in the general population.

Lilly has taken a leadership role, boosting enrollment of diverse populations in trials and making trials more accessible to minority communities. We have goals across our therapeutic and product lines to achieve greater diversity among patients enrolling in new clinical trials.

For more about Lilly's Diversity in Clinical Trials, click here.

[1] The Office of Minority Health. Diabetes and African Americans and Diabetes and Hispanic Americans. 2009. Available at: http://minorityhealth.hhs.gov/templates/content.aspx?lvl=3&lvlID=5&ID=3017 and http://minorityhealth.hhs.gov/templates/content.aspx?lvl=3&lvlID=5&ID=3324. Accessed November 16, 2009.

[2] B. Evelyn, K. Gray & R. Rothwell (Office of Special Health Issues, U.S. FDA), U.S. Black Participation in Clinical Trials: A Review of Selected New Molecular Entities Approved 1998-2001, Presented at the NMA Annual Meeting, Honolulu, Hawaii, 2002. Data on file, Lilly USA, LLC: B2B07092009A.

[3] A "diverse clinical site" is defined as any clinical-trial site where the patient population (of the medical practice, not necessarily who they enroll into trials) is more than 25 percent non-Caucasian.