A
group
of
131
healthcare
organizations
sent
a
letter
on
Monday
to
U.S.
House
Representatives
supporting
the
recent
introduction
of
the
Clinical
Trial
Modernization
Act.
The
bill
aims
to
make
it
easier
for
patients
to
participate
in
clinical
trials.
The
signatories
include
the
American
Cancer
Society
Cancer
Action
Network,
the
National
Health
Council,
the
American
Pharmacists
Association,
the
National
Alliance
on
Mental
Illness,
the
Association
of
Black
Cardiologists
and
many
more.
It
was
addressed
to
Reps.
Raul
Ruiz
(D-California)
and
August
Pfluger
(R-Texas).
Specifically,
the
bill
would
allow
sponsors
to
cover
both
medical
(like
copays)
and
non-medical
costs
(such
as
travel,
lodging
and
childcare)
related
to
clinical
trials,
and
provide
patients
with
digital
health
tools
needed
for
remote
participation
at
no
cost.
It
would
also
support
outreach
to
underrepresented
communities
through
HHS
grants
and
ensure
that
up
to
$2,000
in
trial-related
financial
support
is
not
taxed
or
counted
against
eligibility
for
safety
net
programs
like
Medicaid.
“These
important
provisions
are
key
to
increasing
clinical
trial
participation
and,
thereby,
driving
innovation
and
the
development
of
new
treatments,”
the
letter
stated.
The
organizations
noted
that
getting
patients
enrolled
in
clinical
trials
is
a
frequent
challenge.
And
some
groups
are
often
underrepresented,
such
as
rural
populations,
certain
racial
and
ethnic
groups,
older
adults
and
those
with
lower
incomes.
Costs
are
also
a
significant
barrier
for
many
patients,
as
there
are
often
cost-sharing
requirements
in
order
to
be
covered
for
medical
trials.
In
addition,
patients
sometimes
have
to
travel
so
they
can
participate
in
clinical
trials,
which
means
they
have
to
pay
for
transportation,
lodging
and
meals.
This
is
especially
true
when
it
comes
to
cancer-related
clinical
trials,
as
there
are
fewer
locally
available
trials.
Due
to
these
costs,
there
is
often
a
disparity
in
participation
rates
between
high
and
low-income
patients
and
patients
from
different
geographies,
the
letter
noted.
For
example,
cancer
patients
from
households
with
an
income
of
less
than
$50,000
a
year
are
about
30%
less
likely
to
enroll
in
clinical
trials.
The
organizations
stated
that
offering
reimbursement
for
non-medical
costs
like
travel
can
increase
participation
from
underrepresented
groups.
“While
some
trial
sponsors
provide
financial
support
for
non-medical
costs,
those
that
do
not
often
cite
concerns
about
violating
federal
restrictions
on
providing
patients
with
what
could
be
viewed
as
a
financial
incentive,”
they
said.
“For
patients,
especially
low-income
patients,
the
receipt
of
financial
support
can
create
challenges
with
potential
tax
burdens
for
any
stipend-style
payments,
or
potential
disqualification
from
safety
net
programs
if
such
trial
support
is
considered
income.”
Photo:
Deidre
Blackman,
Getty
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