Eli Lilly announced findings from a prospectively designed observational study that resulted in new ways to increase minority participation in clinical trials. 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.

The study assessed the impact of ethnicity on the second-line treatment of non-small cell lung cancer, or NSCLC. When the study began, it had 19% minority representation, including 28 African Americans, 7 Asian Americans and 10 Hispanic Americans.

Lilly took steps to increase the number of underserved minority participants. This include the selection of new trial sites likely to include more than 50% 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. Moreover, all patient materials were translated into Spanish.

The company 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.

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% of the remaining enrollees representing multicultural populations, with the trial ultimately not reaching critical mass on the Asian American and Hispanic American arms.

Coleman Obasaju, senior medical director at Lilly Oncology, said, "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."