Clinical Diversity Strategy
In the U.S., minority populations have historically and consistently been under-represented in clinical trials, which evaluate the safety and efficacy of new medicines and treatments. Therefore, important information about how medicines work in diverse patients often is unavailable.1 This issue is critical because patients’ responses to medicines can vary by ethnicity, lifestyle and genetic backgrounds.2,3
Diseases impact patient populations differently, and medicines behave differently in some populations, impacting certain racial groups in greater numbers and causing variability in safety and efficacy results.3,4 These factors compel Lilly to thoroughly consider these differences as populations are shifting in the United States and globally.
A greater representation of diverse populations in clinical trials is needed to make medicines most effective for all people who use them.
As part of Lilly’s goal to improve health outcomes for patients, the company is taking a leading role in the pharmaceutical industry to increase minority representation in clinical trials. Lilly is increasing enrollment of diverse populations and making trials more accessible in minority communities. The approach is simple: Match the disease prevalence rate in clinical trials to reflect the general population. To do that, Lilly is identifying and investing in new relationships with clinical investigators who are likely to treat more diverse populations — making it easier for patients to participate.
“Diversity is non-negotiable. Diversity is at the core of who we are, what we value and who we serve. Our team, our partnerships and our values empower us to deliver individualized medicines to patients who depend on us.” John Lechleiter, Ph.D., Chairman, President, and Chief Executive Officer, Eli Lilly and Company
Resources
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Learn more about Lilly’s Clinical Diversity Strategy, the importance of clinical trials and how to become a clinical trial investigator.
New diversity resources coming soon! |
1 Increasing Minority Population in Clinical Research. The Endocrine Society, 2007. Available at www.hormone.org/Public/clinical_trials_content/loader.cfm?csModule=security/getfile&pageid=1131. Accessed on January 5, 2011.
2 Annelle B. Primm, M.D., MPH; Richard A. Levy, Ph.D.; Debra Cohen; Alison Bondurant. Improving Outcomes for Adult Depression in Ethnically and Racially Diverse Patients. Available at www.medscape.org/viewarticle/702891. Accessed on January 5, 2011.
3 Guidance for Industry Collection of Race and Ethnicity Data in Clinical Trials. U.S. Department of Health and Human Services; Food and Drug Administration; Center for Dug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiologic Health; Office of the Commissioner. September 2005. Available at www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.pdf. Accessed on January 5, 2011.
4 Investigational New Drug Applications and New Drug Applications. U.S. Food and Drug Administration. February 11, 1998. Volume 63, Number 28. Available at www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm120254.htm. Accessed on January 5, 2011.