Observational Study Leads to Systemic Approach to Improve Minority Enrollment
Racial and ethnic minorities are more likely to develop cancer and die from it than the general U.S. population. However, as the next generation of cancer medicines are being evaluated, only 17 percent of clinical trial participants are, in fact, minorities.
Eli Lilly and Company has announced findings from a prospectively designed observational study that resulted in new ways to increase minority participation in clinical trials. The study, released at the American Association for Cancer Research (AACR) annual “Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved” meeting in Washington, D.C., assessed the impact of ethnicity on the second-line treatment of non-small cell lung cancer (NSCLC).
As part of Lilly’s goal to improve health outcomes for all patients, the company is working to increase enrollment of diverse populations in clinical trials, and making trials more accessible in minority communities.
“Our mission is to develop tailored therapies for some of the most difficult-to-treat tumors, in the populations that need them most,” said Coleman Obasaju, M.D., Ph.D., senior medical director at Lilly Oncology. “Since lung cancer outcomes differ for different racial groups, it is imperative that these populations are represented in clinical trials.”
When the study began, it had 19 percent minority representation, including 28 African Americans, 7 Asian Americans and 10 Hispanic Americans. Historically, there are a variety of reasons that minorities don’t participate in clinical research, including: lack of awareness of clinical trial research; economic factors; language and cultural barriers; and participant mistrust.
Lilly then took steps to increase the number of underserved minority participants, including: the selection of new trial sites likely to include more than 50 percent minority patient populations; providing patients with information regarding patient assistance programs that help them secure treatment; and on-site visits to trial sites to identify and address existing barriers. In addition, all patient materials were translated into Spanish. Following the trial, Lilly began creating culturally competent patient tools, such as a Latino Toolkit that provided trial sites with information that supported efforts in recruiting and supporting Hispanic American patients on future trials, which were developed in partnership with the Education Network to Advance Clinical Trials.
Lilly also sponsored multiple advisory boards and conducted a survey of 241 clinical trial investigators and coordinators to assess the impact of protocol design on minority participation. The results showed that certain improvements, such as the use of patient navigators who help guide a patient through the treatment process, and taking into account language and ethnic considerations of potential participants when designing trial protocols, were called for. With these enhancements in place, minority participation increased, with 43 percent of the remaining enrollees representing multicultural populations (37 African Americans, 30 Asian Americans and 18 Hispanic Americans), with the trial ultimately not reaching critical mass on the Asian American and Hispanic American arms.
“While the study fell short of its planned patient accrual, with only 434 of 1,000 patients enrolled, it proved that minority participation in clinical trials can increase dramatically with targeted interventions,” said Dr. Obasaju. “We will apply these learnings to future trials right from the start,” he added.
Lilly’s clinical trial strategy includes efforts to educate and encourage physicians and patients to understand the importance of diversity in clinical trials, as well as partnerships with other organizations committed to the same goal.