Abstract B16: Improving representation of diverse patients in clinical trials

Background: Eli Lilly and Company makes medicines that help people live longer, healthier, more active lives. The company9s commitment to clinical diversity is based on the goal of improving individual patient outcomes through tailoring the drug, dose, timing of treatment and relevant information. In a prospectively designed observational study to assess the impact of ethnicity on the effect of second-line treatment in non-small cell lung cancer (NSCLC), accrual fell short of the planned sample size, among African Americans (65 of 200 planned, or 33% of plan), Asian Americans (37 of 200 planned, or 18%), and Hispanic Americans (28 of 200 planned, or 14%). This failure led to the development of new efforts to increase clinical trial participation among traditionally underrepresented populations. Methods: Historically, barriers to participation by minorities in clinical trials included lack of awareness of clinical trial research, financial/economic factors, lack of opportunity, language and cultural barriers, and participant mistrust. To combat these barriers, Lilly has taken several proactive steps. These included selection of sites likely to include >50% minority patients, education initiatives regarding patient assistance programs, and visits to sites to proactively identify and address barriers to minority enrollment. All patient materials have been translated into Spanish. Lilly employees have participated in the AACR Minority in Cancer Research Council and have partnered with the NMA, NHMA, and ENACCT to develop culturally competent patient tools, such as a Latino Toolkit. More than 600 investigators/coordinators were contacted to participate in a survey assessing the impact of protocol design and informed consent documents on diversity of enrollment; it has received 241 responses (37%). Resulting process improvements have included the use of patient navigators and language on ethnic considerations in protocols. Lilly has also sponsored multiple advisory boards focused on diversity in clinical trials. Results: When these steps were undertaken, 242 of 434 total patients had already been enrolled in the observational study. At the time, the study had 19% minority representation, including 28 African Americans, 7 Asian Americans, and 10 Hispanics. After these steps were taken, 43% of the remaining 192 patients who were enrolled in the observational study were minority, including 37 African Americans, 30 Asian Americans, and 18 Hispanic Americans. Eli Lilly also subsequently observed improvements in minority enrollment in lung cancer trials generally. Among both African Americans and Hispanics, the difference between US lung cancer prevalence and participation in Lilly trials has been reduced. In 2006, the difference between US lung cancer prevalence and trial participation among African Americans was 7%, a difference that was reduced every year until 2010, when trial participation exceeded lung cancer prevalence. Caucasians, who have historically been overrepresented in trials relative to disease prevalence, now participate in Lilly lung cancer trials at a rate that better reflects disease prevalence. Conclusion: The observational study prompted Lilly to take a systematic approach to minority enrollment. Because these initiatives began after the start of the observational study, accrual in that trial fell short of plan. Nonetheless, this report indicates that targeted interventions can make a difference. These steps should be taken prior to trial initiation. Citation Information: Cancer Epidemiol Biomarkers Prev 2011;20(10 Suppl):B16.