DALLAS, July 1, 2024
/PRNewswire/ -- 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With the release of the FDA draft guidance on June 26, 2024 the clock starts running on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Specifics on the draft guidance: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Robert M Califf, M.D. "The agency's draft guidance is an important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
dbryson@totalcro.com
www.totaldiversity.com
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SOURCE TOTAL Diversity