[US regulatory agency makes ‘big change’ to increase the
number of participants from under-represented groups in drug testing.]
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FDA TO REQUIRE DIVERSITY PLAN FOR CLINICAL TRIALS  
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Max Kozlov
February 16, 2023
Nature [[link removed]]

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_ US regulatory agency makes ‘big change’ to increase the number
of participants from under-represented groups in drug testing. _

The US Food and Drug Administration regulates products such as
vaccines and over-the-counter medicines., Pavlo Gonchar/SOPA
Images/LightRocket via Getty

 

The US Food and Drug Administration (FDA) will soon require
researchers and companies seeking approval for late-stage clinical
trials to submit a plan for ensuring diversity among trial
participants.

Many scientists have applauded the move, which was laid out in a
spending bill signed into law by US President Joe Biden in December
2022. They say that broadening participant pools is important to make
medicines more effective across the whole population. But they are not
yet convinced that the FDA will adequately enforce the new
requirement.

Nonetheless, “this is the biggest change in the regulatory landscape
for clinical-trial diversity in the last three decades”, says Thomas
Hwang, a physician at the Dana-Farber Cancer Institute in Boston,
Massachusetts, who has expertise in pharmaceutical regulation1
[[link removed]].

Stalled efforts

The diversity requirement arrives in the wake of a 2022 report from
the US National Academies of Sciences, Engineering and Medicine
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which found that, although the representation of white women in
clinical trials has improved, progress has “largely stalled” for
minority racial and ethnic groups. Older adults, pregnant people and
individuals with disabilities remain severely under-represented —
and, in some cases, excluded — from US clinical research, the report
found. For example, a recent analysis of new cancer therapeutics
approved by the FDA between 2012 and 2017 found that 79% of the
clinical trials that were used to support the FDA’s decisions
adequately represented women — but only 27% adequately represented
older adults, and only 11% met the bar for minority racial and ethnic
groups2 [[link removed]].
(In this case, ‘adequately represented’ means that the percentage
of, say, women enrolled in a cancer trial approximately matches the
proportion of women in the United States who have that type of
cancer.)

When the make-up of a pool of participants doesn’t reflect the
population that could benefit from a particular drug, it suggests that
the clinical-research findings will not be relevant for everyone, says
Marian Knight, a perinatal epidemiologist at the University of Oxford,
UK. It also undermines trust in the medical establishment, she adds.

During the early stages of the COVID-19 pandemic, for example, some
pregnant people were reluctant to get vaccinated
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the trials that tested the jabs did not include participants who were
pregnant, she says. There ended up being a disproportionate number of
COVID-19-related deaths in pregnant people compared with the rest of
the population, perhaps as result of vaccine hesitancy, says Knight,
who co-authored a 6 February analysis3
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researchers to include more pregnant individuals in clinical trials.

To comply with the diversity requirement, researchers and
pharmaceutical firms will need to list their demographic goals for the
participant pool, their rationale for the goals and an explanation of
how they intend to meet them. This process looks promising, says
Jennifer Miller, a bioethicist at Yale School of Medicine in New
Haven, Connecticut, and a co-author of the cancer-therapeutics
analysis. “This is the first time we’re going to have companies
proactively plan enrolment targets and submit them to regulators.”

Challenges ahead

Before the requirement takes effect, however, the FDA must first
finalize its draft guidance, and then offer the public an opportunity
to comment. These steps could take more than two years.

Aside from the time until implementation, researchers are concerned
about a provision in the December spending bill that allows the FDA to
waive the need for a diversity-action plan in certain circumstances;
for example, during public-health emergencies, or if a disease or
condition is not considered prevalent in the general population. This
broad waiver authority takes the teeth out of the legislation, Hwang
says.

Scientists say it’s unclear how strictly the FDA will enforce the
requirement, and what options it has if a researcher fails to follow
through on their action plan. “Monitoring and enforcing laws has
been a challenge for the FDA in the past,” says Miller.

Charles Kohler, a spokesperson for the FDA, says that the agency is
committed to ensuring that trial participants reflect the populations
that are likely to use the product, and that it is currently reviewing
the powers that it was granted by the December legislation.

Once the FDA implements its diversity requirement, it will be up to
companies and researchers to recruit people to take part in their
trials. To achieve their goals, they will have to focus on the
structural problems that underlie the lack of diversity in
clinical-trial populations, Miller says. For instance, they’ll need
to consider relocating research sites to places that are more
accessible for members of under-represented groups, and should try to
build trust in local communities made wary by past instances of
exploitative medical research.

By itself, the legislation won’t be sufficient to address
long-standing disparities in clinical-trial enrolment, Hwang says. But
Knight says: “It’s fantastic the FDA is taking the approach.” It
could even inspire countries such as the United Kingdom to introduce
similar requirements, she adds. “Having these kinds of levers is the
way to make researchers think about diversity.”

_doi: [link removed]

References

*
Hwang, T. J. & Brawley, O. W. _N. Engl. J. Med._ 387, 1347–1349
(2022).

Article [[link removed]] PubMed
[[link removed]] Google
Scholar
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*
Varma, T. _et al._ _BMJ Medicine_ 2, e000395 (2023).

Article [[link removed]] Google Scholar
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*
Vousden, N. _et al._ _BMJ_ 380, e071278 (2023).

Article [[link removed]] PubMed
[[link removed]] Google
Scholar
[[link removed].]

_MAX KOZLOV is a science journalist whose work has appeared in The
Atlantic, Nature, Quanta Magazine, The Scientist, St. Louis
Post-Dispatch, Behavioral Scientist, and The Public’s Radio._

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* Science
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* Medicine
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* health
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* drug development
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* diversity
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* FDA
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* regulation
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