Empowering Black Americans for Greater Clinical Trial Representation
In honor of Black History Month, Janssen is spotlighting its commitment to increase diversity among its clinical trial participants, and to expand community engagement to build awareness of, and trust in, clinical research within Black communities and other communities of color.
In this blog post, Staci Hargraves, Vice President, Global Head, Patient & Portfolio Solutions, Janssen Research & Development, L.L.C., speaks about Janssen’s efforts to make clinical research more inclusive and equitable for all. She also shares how her experience as a Black woman has inspired her approach to creating a more equitable playing field in clinical research participation and in getting critical medicines to historically underrepresented patients.
What is your background in clinical research? How has your African American heritage shaped your approach in creating more inclusive trials?
I have spent more than 20 years in clinical development strategy, operations and supply chain across various pharmaceutical companies and clinical research organizations (CROs). Over time, I have seen first-hand the lack of representation among people of color in clinical trials and am fortunate to have the privilege to impact change where it truly matters. As a Black woman, I understand the challenges our community faces when it comes to access to healthcare and understanding the full paradigm of options available. As a result, I am motivated each and every day by the desire to address the known health disparities that exist, and more specifically, how clinical trials can be a care option for all. It is important we develop and evaluate treatments for all the populations they intend to treat.
What are the typical participation rates among Black Americans in clinical trials? Where do we need to be as an industry in representing Black patients proportionally as a demographic? What are Janssen's goals in this regard?
While African Americans make up 12.1 percent of the entire U.S. population,1 we have comprised only 8 percent of trial participants as of 2020.2 In some diseases, the facts are more worrisome. In oncology trials we represent only 4 percent of participants in the United States,3 despite having the highest death rates and lowest survival rate of any ethnic group diagnosed with cancer.4
Trial sponsors should have an obligation to enroll study participants with race and ethnicities that are in line with the demographics the disease affects. Janssen has committed to doing so wholeheartedly through our focus on diversity, equity, and inclusion in clinical trials by partnering with CROs and trial sites nationally to make sure our trials’ recruitment efforts reflect the rates of diseases across traditionally underrepresented populations. We have already demonstrated success in this effort: in our ENSEMBLE trial for the COVID-19 vaccine, for example, 13 percent of U.S. participants were Black/African American. That said, there is much more to do across our portfolio and as an industry.
How does Janssen combine patient engagement with a focus on diversity, equity, and inclusion to create meaningful impact in clinical trials?
Our Research Includes Me platform has been an opportunity to educate potential participants on clinical trials and help address any misperceptions the public may have that act as barriers to enrollment. We have equipped healthcare professionals with educational materials to prepare them for conversations about the importance of diversity, equity, and inclusion in clinical trials. We have also partnered with key industry groups, such as the Society of Clinical Research Sites Diversity Awareness Program and Transcelerate’s Diversity in Clinical Trials workstream, to develop programs and tools that foster better patient experiences and care. Overall, we are managing to meet patients where they are with resources and initiatives to uncover and address barriers to participation.
We have also seen that an important factor to increasing Black participation in clinical trials is encouraging the training and recruiting of diverse staff at clinical sites.5 This is why we have sponsored the NMF Diversity in Clinical Trials Research program, which seeks to increase patient diversity in clinical trials by training underrepresented minority clinicians to serve as Principal Investigators.
How is Janssen coordinating with Black community leaders and organizations to increase Black participation in clinical trials?
Janssen is actively strengthening partnerships within our programming in the Black community to start conversations and increase awareness. For one, we have partnered with Chicago’s YWCA chapter to survey its staff and community members on their knowledge of clinical trials. The survey found that only 23% of respondents had ever been asked to participate in a clinical trial, and of those, a little more than half agreed to do so. We have therefore continued working with YWCA Chicago on events with several of our Black leaders in the clinical trials space to offer perspective and help build trust within the community.
Additionally, in partnership with U.S. Mobile Health, we sent a team of clinical trial educators through Southeast U.S. communities to educate people on the importance of diverse participation in clinical research and encourage them to visit ResearchIncludesMe.com. The mobile unit engaged more than 2200 people across these communities, which is a massive success when accounting for social distancing protocols across these jurisdictions.
This kind of grassroots work is so crucial to engaging and empowering people within these communities to make more informed decisions in managing their health and enrolling in trials. It is especially important within Black communities where trust in clinical trials is markedly low due to bad historical experiences such as the Tuskegee study. We acknowledge that we cannot do this alone, and in this we have realized the importance of listening to communities to understand and incorporate their perspectives in our work.
We are looking forward to growing in this space to see how we can continue to drive conversations forward and foster meaningful progress. Diversity and inclusion in clinical trials not only progresses the goals of science and medicine but is also key to advancing health equity and creating a better future for our patients.
February 22, 2022
1 2020 U.S. Population More Racially and Ethnically Diverse Than Measured in 2010. United States Census Bureau website. https://www.census.gov/library/stories/2021/08/2020-united-states-population-more-racially-ethnically-diverse-than-2010.html. Published August 12, 2021. Accessed January 18, 2022.
2 2020 Drug Trials Snapshots Summary Report. U.S. Food and Drug Administration website. https://www.fda.gov/media/145718/download. Accessed January 18, 2022.
3 Nazha B, Mishra M, Pentz R, Owonikoko TK. Amer Soc Clin Oncol Educ Book. 2019. 39:3-10. doi: 10.1200.
4 American Cancer Society. Cancer Facts & Figures for African Americans 2019-2021. https://www.cancer.org/research/cancer-facts-statistics/cancer-facts-figures-for-african-americans.html Accessed January 17, 2022.
5 Impact Report: New Study Finds Site Personnel Race and Ethnicity Highly Correlated with Diversity of Patients Enrolled. Tufts Center for the Study of Drug Development. 2021;23(5). Published November 2021. Accessed January 7, 2022.