Pyxis Partners uniquely positioned to help clinical trial sponsors meet new diversity mandate
Washington, DC (February 15, 2023) – Pyxis Partners, a Washington, DC based public affairs and social impact firm that advances health equity, access and affordability with a unique expertise in authentic work around equity, diversity and inclusion in the healthcare and clinical trial universe, is ramping up support to clinical trial researchers as they work to comply with the new mandate to submit diversity plans for FDA clinical trials. The move is in response to new FDA requirements that clinical trials sponsors will need to provide diversity plans to ensure racial and ethnic diversity of underrepresented populations.
“Implementing diversity, equity, and inclusion strategies to advance health is the hallmark of our community engagement expertise,” said Michael Manganiello, President and CEO of Pyxis Partners.
“We are the nation’s leading consulting firm applying these techniques to medical research, clinical trials, and recruitment by focusing on reaching, engaging and motivating individuals from communities that have been historically underrepresented in medical research. Our expert ability to build networks of key influencers that represent ethnic and demographic diversity enables us to sustain impactful engagement that advances precision medicine,” he said.
The recently enacted Food and Drug Omnibus Reform Act (FDORA) requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol. 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 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.
“Congress has made clinical trial diversity a priority and for the first time created a legal requirement that drugmakers implement actual plans to recruit more diverse participants,” said Bobby Clark, principal at Pyxis Partners, and health policy practice lead. “The biopharmaceutical industry is going to have to apply new tools and techniques to achieve these goals. They are going to have to think differently about how to engage communities that have traditionally been left out of clinical trial research."
The firm partners with clients to help them develop, implement, and measure high impact community engagement strategies designed to bring urgency to their priorities and move decision-makers to action. The firms’ 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.” says Ronnie Tepp, principal at Pyxis Partners, and practice lead for community engagement.
“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.
For more information about working with Pyxis Partners on engagement strategies to ensure diversity in clinical trials, Ronnie Tepp
Pyxis Partners is a public affairs and social impact firm that advances health equity, access and affordability. Leading the way in health policy, advocacy, engagement, government relations, and communications, our team of accomplished leaders has a proven track record of success and delivering results for those we serve. We are a certified LGBT Business Enterprise with the National Gay and Lesbian Chamber of Commerce, and a certified small business with the Department of Small and Local Business Development in the District of Columbia. We operate as a full-service, solution-oriented consulting firm that works as a true partner with our clients to advance policies and programs resulting in positive change and improved health outcomes.