Lilly Steps Up Efforts to Improve Diversity in Clinical Trials

INDIANAPOLIS, Sept. 20, 2011 /PRNewswire/ — 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.(1)

Today, Eli Lilly and Company (NYSE: LLY) 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.

About Lilly Oncology

For more than four decades, Lilly Oncology, a division of Eli Lilly and Company,
has been dedicated to delivering innovative solutions that improve the care of
people living with cancer. Because no two cancer patients are alike, Lilly
Oncology is committed to developing novel treatment approaches. To learn more
about Lilly’s commitment to cancer, please visit www.LillyOncology.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -
through medicines and information – for some of the world’s most urgent medical
needs.

P-LLY

(1) American Cancer Society. “Cancer Facts & Figures 2011.”

http://www.cancer.org/Research/CancerFactsFigures/CancerFactsFigures/cancer-facts-figures-2011

(Accessed August 3, 2011)

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

SOURCE Eli Lilly and Company