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Press Release: 2021-05-13

The FDA Office of Minority Health and Health Equity: Working to advance health equity through diversity in research:

Guest Contributor | May 12, 2021 |

Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.

Today, we are pleased to welcome a guest post from RADM Richardae Araojo, Pharm.D., MS, the Associate Commissioner for Minority Health Director, Office of Minority Health and Health Equity, U.S. Food and Drug Administration.

The FDA’s Office of Minority Health and Health Equity (OMHHE) was established in 2010 with the mission of protecting and promoting the health of racial and ethnic minority and other diverse populations through research, outreach, and communication of science that addresses health disparities. The office’s dedicated staff in the Research and Collaboration and Outreach and Communication programs work with a wide variety of public and private stakeholders to address the needs and concerns of diverse communities through developing tailored educational, outreach, training, and scientific initiatives that advance health equity.

One of our most notable and long-term initiatives over the last decade is the Diversity in Clinical Trials Initiative, a key priority area for OMHHE. In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law. This piece of legislation, specifically section 907, emphasized the need for increased racial and ethnic minority participation in clinical trials. In response to FDASIA, OMHHE created the Diversity in Clinical Trials Initiative which includes an ongoing, multi-media, culturally and linguistically tailored, public education and outreach campaign to raise awareness on the need for racial and ethnic minority participation in clinical trials.

Historically, racial and ethnic minority populations have been underrepresented in clinical trials and the trend persists today. These same communities are often disproportionately burdened by many chronic and debilitating diseases like heart disease and diabetes, making the need for their participation in clinical research even more critical. There are many factors that can be attributed to lower participation rates among racial and ethnic communities in clinical research such as lack of trust in the medical system—in part due to past historical mistreatment—as well as a lack of transportation, time, language barriers, and knowledge or awareness of clinical research opportunities, to name a few.

Addressing barriers to diversifying clinical trials is critical to closing the health equity gap. The OMHHE Diversity in Clinical Trials Initiative includes a public education campaign with new resources added on a continual basis. The underlying premise of the campaign is to add positive messaging reflecting diverse spokespersons who are representative of diverse communities, while tailoring resources to be culturally and linguistically appropriate and translated into multiple languages (e.g. Spanish, Tagalog, Chinese, Vietnamese, among others). The campaign aims to combat myths and educate consumers about key issues while also helping to stimulate dialogue among peers and peer to provider groups.

The multi-faceted campaign includes public service announcements, patient videos, listening sessions, stakeholder engagement, public meetings, webinars, a dedicated website, podcast, print and digital health education, and social media outreach. Materials are easy to read and understand, feature culturally relevant images, and are translated into multiple languages. Videos within the campaign include specific disease and topic areas such as diversity in sickle cell disease clinical trials, Veterans and clinical trials, and the need for diversity in medical device clinical trials. Many videos also feature diverse spokespersons sharing their personal stories about clinical trial participation.

Another key component to the Initiative is stakeholder engagement. We realize that we cannot do this work in a silo and actively find opportunities to engage with stakeholders—including federal partners, industry, non-profit organizations, academia, community organizations, consumer groups, medical providers, among others to encourage diversity and inclusion in clinical trials. For example, we established a memorandum of understanding (MOU) with The Alliance for Multicultural Physicians and with Yale University. With The Alliance, we aim to collaborate on developing educational, outreach, and training initiatives for physicians and the diverse patients they serve to advance health equity. Our MOU with Yale focuses on advancing the Yale Cultural Ambassadors Program, an engagement of community partners to increase participation of diverse and historically underrepresented populations in clinical research. We have worked with many medical professional associations, non-profits, academia, among a range of other stakeholders to amplify the campaign’s reach. FDA also engages with industry collectively as industry is organizing efforts on clinical trial diversity.

Our office continues to work with patients to increase understanding and awareness within diverse communities of the benefits and risks of clinical research and to provide current and accurate information to help make informed decisions.

Achieving health equity requires commitment and dedication from stakeholders from all corners of the public health and research community. We can continue to make a difference when we work together towards this goal.