Clinical Trial Diversity and You

When the masses hear the term “racial gulf,” one of the issues that typically springs to mind is education. But that gulf has also long been a thorn in pharma’s side when it comes to clinical trials.

“The reasons that diverse patients have historically been under-represented
in clinical trials comprise a complex problem set that requires collaborative solutions,” said Michael Jones, senior director for Regional Clinical Operations at Eli Lilly. “These [reasons] range from disparities in healthcare access and quality to cultural beliefs about health and the healthcare system.”

Studies analyzing different populations are key to discovering problems in potential treatments before they reach the market. Increasing minority enrollment in clinical studies, especially in trials for drugs designed to treat diseases with high incidence rates among those populations, can only benefit the drugmaking process.

With this information in mind, Lilly recently began reaching out to minority communities and get them involved in more clinical trials. In 2008, the company added 83 clinical trial sites in areas of the US with high minority populations, and gave a presentation detailing the process at the AMA’s Commission to End Health Care Disparities Conference last weekend.

Following the event, Jones answered a few questions for Pharm Exec.

Pharmaceuctical Executive: How did the company put this initiative into action?

Michael Jones: We are working to identify and develop new relationships with clinical investigators, who are more likely to treat more diverse patient populations, thereby making it easier for these patients to participate in our clinical trials. To ensure that our objectives for improving minority participation are acted upon consistently and woven into the fabric of our central business processes, we have established clear standards of accountability and measures of our progress. In addition to our focus on improving minority groups' enrollment in our clinical trials, we have instituted processes and measures to ensure that medically relevant differences among patient populations are considered early in the drug development process and at key decision points throughout the development lifecycle.

PE: There are 83 new sites; how many sites are there in total, now? What
geographic locations have the greatest number of sites in general?

MJ: Across therapeutic areas Lilly has thousands of active investigative sites. These 83 are new sites established since 2008, where we have focused specifically on increased minority participation in clinical trials.

PE: Did you focus on trying to reach into more Hispanic markets, or were you equally determined to reach other diversity groups?

MJ: We were determined to reach non-Caucasian patients, because they are under-represented in all clinical trials. Lilly's strategy was to reach sites where at least 25 percent of the patients were non-Caucasian.

PE: The new oncology sites seem to only appear in Puerto Rico. Is there a logistical reason for that?

MJ: The main reason there are fewer oncology sites is simply because we didn't have any new oncology Phase III or Phase IV trials that started in the US during this time frame, with at least 25 US-based sites planned.

PE: How did you determine where to locate specific types of trials?

MJ: Our field-based clinical operations staff is charged with identifying and engaging new clinical trial sites, including new diverse sites. They use a number of sources to determine where the intended patient population lives and receives care, and where that intersects with physicians who may already participate or be interested in participating in research.

PE: What was the purpose of this presentation?

MJ: The purpose was threefold. First, to encourage greater participation of minority physicians-educate them on both becoming clinical trial investigators and/or build their knowledge on speaking to their patients about participating. Second, to illustrate that this is a complex problem, and that Lilly is collaborating with credible minority organizations with roots in multicultural communities across the country whose goals address specific disease states among their community members. Our goals align. And third, to share the success that Lilly is realizing based on these efforts and partnerships.