Targeted trial sites, information on patient-assistance programmes, on-site visits, culturally sensitive patient materials and amended protocol designs can all help to increase minority participation in clinical trials, a US study by Eli Lilly has indicated.
Findings from the prospectively designed observational study, which assessed the impact of ethnicity on the second-line treatment of non-small cell lung cancer, were released at the American Association for Cancer Research’s (AACR) annual ‘Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved’ meeting in Washington, DC.
As Lilly points out, racial and ethnic minorities are more likely to develop and die from cancer than the general US population. Yet only 17% of clinical trial participants in oncology are minorities, according to the American Cancer Society.
In line with the shift towards personalised medicine, the company is working to step up enrolment of diverse populations in clinical trials and to make these studies more accessible in minority communities.
“Our mission is to develop tailored therapies for some of the most difficult-to-treat tumours, in the populations that need them most,” commented Dr Coleman Obasaju, 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,” Dr Obasaju noted.
When Lily started the observational study highlighted at the AACR meeting, only 19% of participants came from minority populations, including 28 African Americans, seven Asian Americans and 10 Hispanic Americans.
Historically, the company observes, a variety of reasons have limited minority enrolment in clinical trials. These include mistrust among patients, lack of awareness of clinical research, economic factors, and linguistic/cultural barriers.
Among the steps Lily took to boost the proportion of underserved minority participants in its study were:
- Selecting new trial sites likely to include more than 50% minority patient populations.
- Giving patients information about assistance programmes that would help them to secure treatment.
- On-site visits to trial sites to identify and address existing barriers.
- All patient materials were translated into Spanish.
- Sponsoring multiple advisory boards and conducting a survey of 241 clinical trial investigators and co-ordinators to assess the impact of protocol design on minority participation.
The survey results highlighted the need for improvements such as using patient navigators to help guide patients through the treatment process, as well as taking into account the linguistic and ethnic considerations of potential participants when designing trial protocol.
With these adjustments in place, minority participation in the study increased, with 43% of the remaining enrollees representing multicultural populations (37 African Americans, 30 Asian Americans and 18 Hispanic Americans) – although the trial ultimately did not reach 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,” Dr Obasaju commented.
“We will apply these learnings to future trials right from the start,” he added.