As reports of COVID-19 morbidities and mortalities rose in the United States (U.S.), inequities in the healthcare landscape quickly became apparent, with cases, hospitalizations, and deaths due to the virus disproportionately affecting Black/African American and Hispanic/Latino communities. With these disparities in mind, Janssen, the Pharmaceutical Companies of Johnson & Johnson, knew it was critical to enroll a diverse population of participants in ENSEMBLE, the clinical trial for its COVID-19 vaccine candidate, to ensure that all people who would eventually receive the vaccine were represented.
To ensure diversity and inclusion in the ENSEMBLE trial and based on years of clinical trial experience, Janssen rapidly implemented a multifaceted plan for recruitment and enrollment of participants from underrepresented communities. The approach included intentional site selection, community engagement and awareness building, and educational and training support for investigators. Janssen also took steps to remove barriers clinical trial participants often face, including the use of demographic data to identify and utilize clinical trial sites located in underrepresented communities.
“We are committed to developing medicines and therapies that meet the needs of all people, and we know that diseases and drugs may impact people differently based on their race and ethnicity, so the alignment of clinical trial enrollment with patient population demographics is key,” said Staci Hargraves, Vice President of Patient and Portfolio Solutions, Janssen Research & Development, LLC, and Executive Sponsor of Janssen’s Diversity, Equity & Inclusion in Clinical Trials program. “Simple yet impactful decisions, such as making sure trial sites were located in accessible places within historically underserved communities, made a big difference in our ability to reach more participants.”
Once Janssen selected the ENSEMBLE sites and began recruitment efforts, Janssen’s employees built relationships with trial site investigators and staff to provide cultural competency training to help stimulate dialogue about diversity and maintain focus on enrolling and supporting underrepresented groups. These close collaborations with site leaders allowed Janssen to identify any roadblocks in real time and make changes to the recruitment efforts as needed.
Identifying clinical trial sites in diverse communities was only the first step, because other barriers to recruitment and enrollment also exist. Clinical research in the U.S. has a complicated history when it comes to marginalized populations. Past events such as the Tuskegee Syphilis Study, combined with ongoing systemic disparities in the healthcare system, have contributed to distrust in clinical research among many people. Building trust is critical, particularly given the urgency the pandemic presented.
“We felt it was our role to help people understand how clinical trials work — and how trials have evolved to ensure that participant safety and human rights are protected today,” said Hargraves.
To build trust with communities of color, Janssen worked with both local and national organizations, including prominent community advocacy groups and leaders, along with healthcare professional organizations. These groups helped Janssen identify trusted voices within communities who could disseminate information about ENSEMBLE and clinical research in general. Janssen also used its Research Includes Me patient education program to conduct local outreach, including the consumer-facing website ResearchIncludesMe.com, and the dispatch of mobile units of bilingual educators to large community events. These tools helped to dispel misinformation about present-day medical research by providing accessible and empowering education about the clinical trial process and the protections given to participants’ rights and privacy.
Setting the Bar for Diversity in Clinical Trial Enrollment
Collectively, Janssen’s efforts successfully promoted diverse enrollment in ENSEMBLE. There were 43,783 participants from eight countries across North America (44%), Central and South America (41%), and Africa (15%). More than one-third (34%) of participants were over the age of 60, and 45% were female. In the United States, 74% of participants were White/Caucasian, 15% were Hispanic/Latino, and 13% were Black/African American. Participants with comorbidities were also well-represented in ENSEMBLE, with 41% of participants having obesity, hypertension, type 2 diabetes, or HIV-positive status or other immune system disorders.
The Future of Diversity and Inclusion in Clinical Trials
The pharmaceutical industry must continue to confront underrepresentation in clinical trials and devote time and resources to inclusion, however, it is an evolving process. Using lessons learned from ENSEMBLE and experiences with previous clinical research in other disease areas, Janssen will continue to shape the future of clinical trial recruitment by applying strategic operational practices, making thoughtful investments of time and resources, and facilitating collaborations that build trust in clinical research and reduce barriers to diverse enrollment.
“We are working together with leaders across the pharmaceutical industry to make diversity, equity and inclusion in clinical trials a reality,” Hargraves said. “ENSEMBLE is just one example of how collective efforts can result in success.”
Further Reading
1. Loree JM, Anand S, Dasari A, et al. Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018. JAMA Oncol. 2019;5(10):e191870. doi:10.1001/jamaoncol.2019.1870
2. Diverse Trials Act. 117th Congress (2021-2022). S.2706.
3. The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. Achieving Diversity, Inclusion, and Equity in Clinical Research, Version 1.1. August 2020. https://mrctcenter.org/diversity-in-clinical-research/guidance/guidance-document/. Accessed September 2, 2021.
This article was originally published in Fierce Pharma.