As partners dedicated to advancing diversity and inclusivity in clinical trials, Pyxis Partners and Rx4good welcome the recently released U.S. Food and Drug Administration (FDA) draft guidance on diversity action plan requirements for clinical studies. This crucial step by the FDA underscores the importance of ensuring that clinical trial participants reflect the diversity of the populations that will ultimately benefit from new therapies as a result of these trials and future innovations in health.
The guidance provides a framework for drug manufacturers to enhance diversity in clinical trials, which is not only essential for ethical reasons but also critical for measuring the efficacy and effectiveness of medical treatments across diverse patient populations.
This new guidance is a win for patients and care providers because of the emphasis that the FDA has placed on sustained community and patient organization engagement in guiding trials, cultural proficiency training for clinical trial centers, interpretation and translation services for trial participants, and reducing participant burden by providing transportation and other participant support services, including the possibility of participating remotely, to make these trials more accessible.
In March 2024, Pyxis Partners and Rx4good began a new partnership to guide biopharmaceutical companies in taking steps to engage diverse communities in medical research and fulfill the requirements of diversity action plans. We stand ready to assist biopharmaceutical companies and device manufacturers in developing robust diversity action plans that align with the FDA's guidelines, leveraging our combined expertise in clinical trial strategy and diversity, equity, accessibility and inclusion initiatives. As part of the collaboration, Pyxis Partners and Rx4good offer the following services to biopharmaceutical companies:
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 industry and the health system
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
Together, we believe that by fostering greater diversity in clinical trials, we can improve healthcare outcomes for all patients and contribute to a more equitable healthcare system. We look forward to working collaboratively to achieve meaningful progress in diversity and inclusion within the biopharmaceutical industry. Through these strategies, we will empower these clinical trial sponsors to diversify their recruitment efforts and ensure that new therapies resulting from research will benefit all Americans.
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