Dallas, TX June 28, 2024 PR Newswire – Total Diversity Clinical Trial Management (TDCTM)

With the release of the FDA draft guidance on June 26, 2024 the clock starts running on enacting the Food and Drug Omnibus Reform Act (FDORA). The legislation will be enacted 180 days after final guidance is released. This is another step in the process towards the mandate for Diversity Action Plan (DAP) for all Phase 3 and pivotal studies. Do you have a plan to incorporate DAPs in your drug and device development? The experts at Total Diversity are at the ready to help develop these plans.

Specifics on the draft guidance:

    • Broadens the definition of diversity beyond race/ethnicity to include geography, gender, socioeconomic status, comorbidities, pregnancy status – this does raise the level of data to be collected to ensure further safety. This will better ensure broader applicability of results across populations. We can help.
    • Requires descriptions, in detail, the operational measures used to enroll and retain underrepresented communities. This means detailing the actions taken to engage with communities – this is labor labor-intensive and essential.
    • Describes the format and content of the DAP, as well as timing and process for submission. Missing from earlier guidance this version describes the evaluation process the FDA will use to evaluate a waiver.

“Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M Califf, M.D. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”

This is the premise that has driven Total Diversity’s focus around diversity planning and integration for a decade. Total Diversity is the only CRO built with hitting diversity targets as a primary outcome. Total’s team of experts helps clients to meet enrollment targets in all populations and is ready to execute on your behalf.

The Total team has experience developing detailed DAPs for oncology, expansive and rare diseases. We have experience handling FDA responses to DAPs. We have experience designing and executing the community engagement efforts essential to getting the goals of the DAPs accomplished. Our results have exceeded diversity targets and we can do the same for you.

About TOTAL Diversity Clinical Trial Management, Dallas, TX

TOTAL Diversity Clinical Trial Management is a full-service Contract Research Organization with an integrated focus on support services highlighting diversity and inclusion in clinical trials. Service offerings directed at diversity include consulting, training programs, patient recruitment, retention services and more. The growing network of diverse capable sites includes experienced diversity-oriented researchers as well as those who have access to diverse populations.

CONTACT:

Dyan Bryson
VP, Diversity Services
Total Diversity Clinical Trial Management
201-803-0301
[email protected]
www.totaldiversity.com