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Preparing for the FDA’s Diversity Action Plan requirements.

With the release of the FDA’s 2024 draft guidance about diversity action plans this past June, the industry as a whole is beginning preparations for how to best adhere to these important guidelines.

While sponsors will be responsible for developing their diversity action plans (DAPs), Praxis will work collaboratively to ensure an aligned and focused approach to incorporating an appropriate diversity strategy within each study we support. Our internal Patient Engagement department takes a number of steps to shape our strategy, including collaborating with sponsors to identify the specific diversity, equity, and inclusion (DEI) goals that align with our approach to patient recruitment and retention.

Depending on the sponsor’s diversity goals, protocol, and the scope of the project, this may include:

  • Integrating inclusive imagery and messaging in our creative
  • Customized versioning of materials
  • Thoughtful retention program support
  • Targeting and channels specific to diverse/underrepresented populations for media campaigns
  • Engaging specialized third-party partner relationships
  • Ongoing monitoring and analysis of relevant KPIs
  • Customized materials, videos, or strategies to support sponsor-led initiatives such as site training materials, sustained community outreach, and more

As we await the final guidance and begin to see our sponsors’ DAP approaches come to life, Praxis looks forward to supporting these meaningful efforts.

Connect with us today to start talking about how Praxis can support your DAPs.

 

Praxis is committed to supporting diversity, equity, and inclusion both within the clinical trials we support and throughout our organization and community. Internally, we have an established DEI Council that coordinates initiatives designed to build awareness, grow education, and support local minority-owned businesses and students through dedicated programs. Some of these efforts include ensuring a diversified roster of third-party vendors among our vetted suppliers, completion of Racial Equity Impact Analysis training by all employees, and developing a community initiative to donate agency services to small local and minority-owned businesses.