Diversity in Clinical Research

People respond differently to medicines based on their age, sex, race, ethnicity and other factors – and that means diverse representation in clinical trials, where medicines are tested for safety and effectiveness – is critical.  

Lilly has been working for more than a decade to increase enrollment of underrepresented populations in our studies, but there is more to be done, particularly in oncology. We’ve created a robust strategy to broaden our reach, including intentionally selecting a diverse range of trial sites and investigators, and collaborating with other groups across the cancer care community.  

Reducing Barriers

Lilly Oncology is taking steps to locate clinical trials closer to where minority populations live and work, as well as incorporating more virtual visits. We are leveraging decentralized clinical trial capabilities, using technology, services and updated processes to reduce or eliminate some of the barriers patients face when deciding whether or not to participate in a research study.  

Clinical trial design is another area for improvement. For example, we’re looking at inclusion/exclusion criteria and concomitant medication requirements to ensure we aren’t disproportionately excluding minority patients who have multiple health conditions at higher rates than white patients.  

We’re also reexamining data collection and gathering only what is truly necessary in an effort to further save participants’ time and energy. 

Forming Partnerships

Addressing the deep-rooted problem of diversity in clinical trials requires collaboration, and Lilly Oncology has formed a number of partnerships with patient advocacy groups and community organizations to develop and implement solutions.  

Along with the National Minority Quality Forum (NMQF), a research and educational organization dedicated to ensuring high-risk populations receive optimal health care, Lilly is working to advance health equity in oncology care.

Collaborating with patient advocacy groups is having a direct impact on Lilly Oncology’s work, including helping to find, enroll and build trust among populations historically left out of clinical research.  

Protecting Patients

Medicine’s dark history of exploitation and unethical experimentation (e.g., the harvesting of Henrietta Lacks’ cancer cells) has left many people of color skeptical or even mistrustful of medical research. Lilly is committed to education and honest conversations about today’s clinical trials, which protect participants’ rights with laws and ethics committees such as institutional review boards. 

Lilly is working to recruit more clinical trial investigators and external advisors who represent women, as well as racial and ethnic minority populations, to increase our depth of diverse thought, and to support an up-and-coming group of investigators with the career development that clinical research offers. Another benefit, people are more likely to volunteer for a trial if the investigator speaks their native language or is familiar with their culture.  

These initiatives, along with new learnings and ongoing flexibility, will help Lilly Oncology continue to identify and address potential obstacles – imperative as we work to ensure our oncology advancements reflect all those who may need them.