For immediate release
March 5, 2024
Contact: Matt Holzapfel
Diversity Action Plan requirements, when finalized by FDA, will improve inclusion of communities historically underrepresented in medical research
Washington, DC (March 5, 2024) – Last week members of the Congressional Committee on Energy and Commerce wrote a letter to the Food and Drug Administration (FDA) urging the regulator to prioritize the requirements of the Food and Drug Omnibus Report Act (FDORA) of 2022 to make clinical trials more representative.
To address the requirements of FDORA on biopharma companies, two leading social impact consultancies – Pyxis Partners and Rx4good -- formally announced this week that they are uniting to guide biopharmaceutical companies in taking steps to engage diverse communities in medical research and fulfill the requirements of diversity action plans.
Pyxis Partners is the leading Washington, DC-based public affairs firm focusing on advancing equity, access, and affordability of healthcare for all. Rx4good is a virtual global firm specializing in patient engagement and patient advocacy to advance what is humanly possible in healthcare. The firms will partner with biopharmaceutical companies to help them develop, implement, and measure high impact community engagement strategies designed to bring urgency to their recruitment efforts and fill their trials with the diversity needed to ensure that new therapies resulting from research will benefit all. The following services will be offered as part of the collaboration:
Listening and learning from representative patients and communities to:
identify and understand the human dimensions of a disease experience, the physical and psycho-social impact, demographic and geographic barriers to care, personal hurdles, and unmet needs
understand the needs of the community on a local and regional level and their trust hurdles with the industry and health systems
Engaging representative communities to demonstrate long term commitment:
co-developing strategies with clients and communities for building trust relating to medical innovation
co-creating clinical protocols that address community and company needs for progressing research
co-creating clinical trial communications that address community perspectives in educating about trials
Pyxis Partners has unique expertise in authentic work around equity, diversity, and inclusion in the healthcare and clinical trial universe with deep roots into diverse communities in the US. Rx4good has expertise in guiding companies, government, academia and nonprofits in forging partnerships to improve the lives of patients.
FDORA requires clinical trial sponsors of any Phase III or other pivotal drug study to submit diversity action plans. The purpose of the law is to require researchers to have a strategy to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the United States at the beginning of the research. The purpose of the new requirement is to address knowledge gaps on how drugs would work in more representative samples of the US population. Currently most clinical trial research is done with white men.
According to last week’s Congressional letter to FDA, “despite FDA’s current recommendations on how to operationalize diversity plans, historically marginalized populations, such as certain racial and ethnic groups and women, are still underrepresented in many clinical trials. In fact, at least one report shows that inclusion of Black patients in clinical trials declined over the last decade.”
“We are eager to collaborate with Pyxis Partners to guide clients in trust-building activities with diverse communities so that clinical trial representation becomes an industry standard,” said Ann Moravick, Rx4good CEO. “We know that our combined expertise will bring strategic, thoughtful and results-oriented solutions to companies as they formulate diversity action plans.”
“Community engagement takes time and an investment to build trust,” said Ronnie Tepp, principal at Pyxis Partners, and community engagement practice lead. “It’s about developing mutually beneficial, long-lasting relationships in communities that are skeptical - and for good reason - of the biomedical research enterprise. Our community engagement approach is grounded in best practices and fueled by the knowledge that impactful engagement requires meeting people where they are - not only where they live, work and play, but also where they are in their personal journey from awareness to action.”
Achieving diversity in clinical trials requires an ability to go deep into communities through trusted messengers and an investment in time, energy, and resources to educate communities about participation in clinical research, build trust and learn about how different communities think about value. It requires a move away from the transactional approach focused on engaging with a specific community to fill a specific trial. Pyxis’ ability to build networks of key influencers that represent ethnic and demographic diversity allows for sustained, impactful engagement that advances precision medicine.
“We are uniquely positioned to help researchers and industry sponsors make this shift. We have the right team, the right relationships, and a proven track record working with public and private sector clients to build long-lasting relationships with communities underrepresented in biomedical research throughout the country based upon trust, transparency, and bi-directional communication to advance a wide variety of health-related issues.” Tepp continued.
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