New approaches to advance equity in clinical trials
Global inclusion & diversity
New approaches to advance equity in clinical trials
One of the many barriers to recruiting diverse clinical trial cohorts is the location of trial research sites — typically at major academic medical centers, whose patient populations tend to include fewer members of typical underrepresented groups than those found in many other healthcare settings. To solve for this, BMS is working to ensure that research sites are accessible to underrepresented groups, based on U.S. census and epidemiological data.
This approach is making an impact. In 2020, we committed to locating at least 25 percent of U.S. research sites for new clinical trials in racially and ethnically diverse communities. By the end of 2022, 58 percent of our U.S. research sites were located in such communities — more than double the percentage reached the previous year.
To further expand access, our clinical trials provide patient support ranging from extended clinic hours to home nursing visits and telehealth consultations. “As part of our commitment, we are working to remove barriers when it comes to participating in our clinical trials — from transportation challenges to flexible scheduling,” explained Hirawat. “We incorporate patients’ experiences, perspectives, priorities and needs into our trial designs.”
Because research shows that patients from underrepresented groups often feel a greater level of trust with healthcare workers who share their racial or ethnic background, we are also developing initiatives aimed at diversifying the demographics of our principal investigators.
The BMS Foundation, funded by Bristol Myers Squibb, has developed initiatives to increase the number of diverse investigators in underserved areas. Learn more about diversity in clinical trials and developing talent through experience.
Taking a more comprehensive view of diversity to reach more patients
Beyond issues of race and ethnicity, BMS is working to ensure that our clinical trials address the needs of other underrepresented groups. In May 2022, we announced the launch of the Disability Diversity in Clinical Trials (DDiCT) Initiative — a collaboration with Disability Solutions, a U.S.-based nonprofit organization that supports companies globally in achieving disability inclusion — with the objective of assessing the needs of people with disabilities and their participation in clinical trials.
Addressing disparities for LGBTQI+ people
Another cohort that has long been overlooked in clinical trial design is the LGBTQ+ community. The scarcity of available data creates obstacles to addressing health disparities by sexual orientation, gender identity and intersex status (SOGIIS).
To help remedy this, BMS began collecting SOGIIS data in 2022 from adult patients in the U.S. who voluntarily self-identify, using electronic patient report outcome (ePRO) methodology.
“This is a huge step forward that will contribute to more meaningful dialogue during clinical encounters, increase quality care, and address health disparities affecting LGBTQ+ persons,” said Estelle Vester-Blokland, global head of medical affairs and executive sponsor of the PRIDE Alliance PBRG. “Including SOGIIS data in our trial design benefits all patients by ensuring there is a place for everyone in the healthcare system to receive equitable quality care.”
Expanding our GI&D strategy to address local diversity
As a global business, we know that the term “diversity” is defined differently around the world. Our GI&D strategy addresses the nuance of diversity by creating market strategies to address inclusion on a local level. We believe that the value of making pharmaceutical research more inclusive transcends borders, and we are pursuing country-specific efforts to increase clinical trial diversity, reflecting local needs and priorities.
In 2022, two new initiatives in Latin America demonstrated the promise of that approach.
In Argentina, the majority of the population is treated at public hospitals, yet most clinical trials take place in the private health sector. To address this imbalance, BMS Argentina launched the ESSENCE project, which is proactively working with stakeholders across the system to increase the number of company clinical trials in the public sector.
In Brazil, 91 percent of clinical trials are conducted in the country’s urbanized southern and southeastern regions, and only 9 percent in other areas, where larger proportions of the population are Black or Indigenous. The Inclusion in Focus initiative, launched by BMS’ Regional Clinical Operations Brazil (RCO-Brazil), aims to substantially increase participation in those underrepresented regions by 2025.
The project will identify and assess potential sites, select feasible candidates and develop strategies for building a robust infrastructure for those facilities. “Inclusion in Focus puts BMS at the forefront of study sponsors striving to increase clinical trial diversity in the world’s seventh-most-populous nation,” observed Sharon Hanlon, senior director, Clinical Trial Engagement & Enrollment.
The company is investigating ways to further equity in clinical trials in other countries where we conduct such research. “We’ve made advances, but there’s still more to do,” said Hirawat. “Remembering that keeps us inspired and motivated.”