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From YouTube: Examining Diversity in COVID 19 Trials
Description
Finding a safe and effective treatment for COVID-19 remains a top priority for policymakers in the U.S. As the nation comes closer to a vaccine, many individuals have volunteered to join clinical trials. However, racial and ethnic minority groups have been underrepresented in these trials. During this webinar, hear from experts on how clinical trials operate, current COVID-19 clinical trials and efforts to include broader demographics in the research.
A
Good
afternoon
and
thank
you
for
joining
us
for
today's
national
conference
state
legislatures
webinar,
examining
diversity
in
covit
19
clinical
trials.
My
name
is
sydney
enlin,
and
I
am
a
policy
specialist
in
ncsl's
health
program
and
I'll
be
your
moderator.
For
today,
before
we
introduce
our
speakers,
I
want
to
review
a
few
housekeeping
items.
Today's
webinar
is
a
platform
for
information
exchange
and
engagement
over
the
next
60
minutes.
A
We
encourage
participation
through
our
chat
box,
so
feel
free
to
type
your
questions
and
answer
any
questions
in
the
chat
box
on
your
screen
to
begin
building
some
comfortability
with
the
chat
function
and
also
to
learn
who
is
on
the
line
today,
I
invite
you
to
type
in
the
state
from
which
you
are
calling
from
right.
Now
we
will
hold
a
formal
q,
a
after
our
presenters
are
finished.
Presenting
I
want
to
briefly
mention
the
resources
above
the
presentation.
A
A
These
tabs,
at
any
time
during
the
presentation,
the
webinar
platform
we
are
using,
is
optimized
for
use
in
google
chrome,
while
other
web
browsers,
such
as
firefox
may
work.
We
recommend
anyone
experiencing
technical
difficulties,
try
signing
in
through
chrome.
Instead,
if
you
continue
to
experience
technical
issues,
please
email
registration
at
ncsl.org,
where
our
team
is
ready
to
assist
you.
A
A
Staff,
so
again,
we
are
here
today
to
talk
about
diversity
in
clinical
trials.
Finding
a
safe
and
effective
treatment
for
covid19
remains
a
top
priority
for
policymakers
in
the
u.s.
As
the
nation
comes
closer
to
a
vaccine,
many
individuals
have
volunteered
to
join
clinical
trials.
However,
racial
and
ethnic
minority
groups
have
historically
been
under-represented
in
these
trials.
A
During
this
webinar
we'll
hear
from
experts
on
how
clinical
trials
operate,
current
covid19
clinical
trials
and
efforts
to
include
broader
demographics
in
the
research
state
legislators
across
the
country
have
increasingly
become
interested.
In
this
topic.
Broadly
and
since
the
covit
19
pandemic
began,
there
has
been
a
particular
interest
in
diversity
in
clinical
trials
as
the
infection
hospitalization
and
death
rates
for
covet
19
in
the
united
states
are
significantly
higher
for
black
hispanic,
american,
indian
and
alaska
native
populations.
A
A
clinical
trial
is
a
research
study
on
human
patients
to
test
the
safety
and
effectiveness
of
new
treatments.
These
trials
offer
patients
access
to
new
and
potentially
life-saving
drugs
and
cures.
More
than
half
of
the
states
have
enacted
laws
to
mandate.
The
coverage
of
or
insurers
have
agreed
to
cover
clinical
trials.
A
Several
states
have
enacted
legislation
related
to
clinical
trials
this
year,
for
example,
colorado
enacted
a
bill
called
equity
and
access
to
clinical
trials
and
medicaid.
The
act
authorizes
the
state
medicaid
program
to
cover
routine
costs
associated
with
phase
1
through
phase
4
clinical
trials
involving
the
prevention,
detection,
diagnosis
or
treatment
of
life-threatening
or
debilitating
diseases
or
conditions.
B
A
A
Dr
mensah
is
a
clinician
scientist
trained
in
internal
medicine
and
and
the
subspecialty
of
cardiovascular
diseases.
His
professional
experience
includes
17
years
of
public
service
between
the
u.s
department
of
veterans
affairs
and
the
centers
for
disease
control
and
prevention.
His
bio
is
available
under
the
bios
tab.
Thank
you.
So
much
for
joining
us
today,
dr
mensah.
The
floor
is
now
yours.
B
Thank
you
very
much
sydney.
I
really
appreciate
the
introduction
and
thank
all
of
you
for
making
time
to
listen
to
us.
I
must
tell
you
agreeing
to
participate
in
this.
Webinar
was
very
easy
because
I
recall
two
decades
ago,
in
a
previous
life,
when
I
worked
at
the
cdc,
the
ncsl
was
a
major
partner
and
you
were
actually
very,
very
effective
in
helping
us
when
we
put
together
the
state-based
heart
disease
and
stroke
prevention
program.
So
thank
you
very
much.
B
I
remember
the
last
time
I
spoke
with
you
was
16
years
ago,
so
hopefully
I
will
be
in
touch
more
often,
and
I
wouldn't
have
to
wait
another
another
16
years
to
speak
with
you.
So
a
big
thank
you
and
I
bring
you
greetings
from
the
leadership
at
nih,
in
particular
dr
francis
collins,
who
has
been
very,
very
passionate
about
our
scientific
response
to
this
covet
pandemic.
B
I
was
very
delighted
to
hear
what
sydney
went
through
in
terms
of
the
legislation
and
the
laws
that
you've
passed
in
your
state
and
again
a
big
thank
you
for
that.
We
know
there's
a
lot
that
you
can
do
in
my
portion
of
the
presentation,
I'll
try
to
answer
these
five
questions
that
you
see
here.
I've
actually
put
in
more
slides
only
for
your
benefit,
so
I
know
you
have
access
to
it
and
you
can
go
to
each
one
later
on,
so
I
do
not
intend
to
spend
a
lot
of
time
on
each
slide.
B
I
really
want
to
make
sure
we
save
enough
time
for
questions
so
I'll
go
ahead
and
begin
with
the
first
question:
what
are
clinical
trials,
and
why
are
these
clinical
trials
important
as
sydney
mentioned
in
the
introduction?
It's
fairly
simple.
By
way
of
definition,
a
clinical
trial
is
a
type
of
research
or
experiment
that
is
done
in
people
for
two
main
reasons
to
determine
if
an
intervention
is
safe
and
if
it
is
effective
and
these
interventions
can
be
drugs
or
they
can
be
test.
But
the
most
important
message
on
this
slide
is
safety.
B
B
Give
you
a
sense
of
some
of
the
assurances
we
provide,
for
example,
before
even
anyone
begins
to
participate,
the
entire
set
of
risks
and
the
benefits
of
the
trial
I
explained,
and
then
they
sign
an
informed
consent.
That
is
the
process
to
make
sure
that
volunteers
don't
have
any
questions
and
there
are
very
rigorous
ethical
standards
that
every
researcher
must
follow
and,
again
importantly,
the
participant
is
at
will
to
stop
participation
at
any
time.
So
safety
is
critical.
B
We're
going
to
a
phase
two
trial?
The
bottom
part
of
the
chart
shows
the
relative
numbers
of
people
you
need
in
in
each
of
these
phases.
So
in
a
phase
one
trial,
you
need
only
about
20
to
80
in
a
phase
2
trial.
You
certainly
need
more
than
that
can
be
a
few
dozen
to
several
hundred
and
about
a
third
of
these
trials.
Progress
into
a
phase
three,
the
one
that
you
most
likely
hear
about
more
often
is
the
phase
three
trial.
B
It's
important
that
we
highlight
in
diversity
and
inclusion
in
clinical
trials,
because
that
is
really
really
critical
because
to
find
a
vaccine
or
drug
that
is
safe
and
effective
in
all
kinds
of
people.
It
makes
sense
that
it
be
tested
in
all
kinds
of
people,
so
clinical
trials
that
include
men
and
women
from
diverse
racial
and
ethnic
backgrounds,
give
us
a
much
greater
assurance
that
it
will
be
safe
and
effective
in
both
men
and
women
in
people
from
diverse
backgrounds.
B
So,
ideally,
these
trials,
for
example,
for
a
covert
19
vaccine
are
best
designed
when
they
are
raw
participants
from
communities
that
have
been
harvested
by
the
pandemic,
because,
obviously,
when
we
have
an
effective
vaccine,
this
is
a
community.
We
also
want
to
make
sure
we
get
to
so
we
can
save
the
most
lives.
B
This
slide
shows
you
some
of
the
reasons
why
it's
important
to
pay
attention
to
underserved
racial
and
ethnic
communities
that
have
been
hit
really
hard
by
this
pandemic.
For
example,
when
you
look
at
in
the
communities
of
african
americans,
even
though
they
make
up
only
13
of
the
us
population,
they
contribute
about
20
of
the
cases
and
about
as
much
in
terms
of
proportion
of
deaths
for
hispanics
and
latinos,
though
they
make
up
only
18.
B
B
The
reason
why,
in
spite
of
these
challenging
numbers,
we've
historically
had
difficulty
in
ruling
african
americans,
hispanics
and
american
indian
alaska
natives
is
because
of
the
the
exclusion
in
previous
trials
and
also
in
cases
where
they
have
been
exploited
and
so
we're
dealing
with
a
major
problem
of
distrust
mistrust
in
addition
to
misinformation,
and
that's
why
it's
important
that
we
tackle
this
head-on
now
the
the
problem
of
the
lack
of
diversity
in
clinical
trials.
It's
not
a
new
problem,
we've
known
about
it
for
a
while
and
in
the
next
few
slides.
B
B
And
if
you
look
in
this,
the
the
the
diagram
to
the
right
that
shows
the
total,
although
by
720
people
were
recruited
into
both
trials,
there
are
only
five
people
recruited
who
were
black
and
all
other
racial
and
ethnic
groups
about
22
about
74
asian.
So
this
is
only
one
example
showing
that
it's
it's
a
real
challenge
in
addressing
disparity,
one
of
the
main
questions
you
wanted
us
to
address
as
the
extent
of
racial
and
ethnic
diversity
in
the
current
vaccine
trials
and
obviously
the
most
current
real-time
data.
B
So
I'm
showing
you
two
types
of
bars,
the
darker
cyan
or
green
bar
is
the
data
on
race,
ethnicity,
in
the
registry
and
in
the
lighter
green
of
each
couple
of
bars
is
the
first
one,
the
lighter
green,
that's
the
race
ethnic
proportion
in
the
particular
trial,
so
for
the
astra
zelicah
vaccine
trial,
for
example.
At
the
time
this
was
done
about
80
percent
of
the
people
in
the
registry,
as
well
as
people
in
the
trial
were
white.
B
If
you
ask
how
many
were
hispanic
less
than
ten
percent,
both
in
the
registry,
as
well
as
in
the
trial
itself
for
black
or
african
americans,
was
less
than
five
percent.
That
picture
is
the
same
when
you
look
in
the
johnson
vaccine
trial
and
you
look
at
the
modern
vaccine.
Try
I'll
have
a
little
bit
more
to
share
with
you
on
more
recent
data
for
the
modern
vaccine
trial.
B
The
important
message
from
what
we
know,
given
the
three
slides
I
shared
with
you,
but
also
the
lack
of
diversity
in
clinical
trials,
whether
it's
cancer
or
diabetes
or
heart,
disease
and
stroke.
A
few
things
one
is
that
the
misconception
that
minorities
in
general
don't
like
to
participate
in
trials.
So,
let's
not
waste
time.
There
is
a
real
misconception,
because
there
have
been
very
good
trials
well
done,
trials
that
have
showed
that
minorities
actually
are
just
as
willing
to
participate.
B
If
you
take
the
time
to
explain,
take
the
time
to
respect,
take
the
time
to
pay
attention
to
culture
and
environmental
issues,
they
they
participate
just
as
well,
and
I
have
an
example
to
share
with
you.
It's
also
important
to
dismiss
the
notion
that
minorities
are
not
interested
in
research
in
general.
They
are
when,
given
the
right
information
when
reached
using
the
right
media,
the
right
channels,
we
can
have
success
in
recruiting
and
enrolling
them
in
trials.
B
So
what
we've
learned
is
that
our
approaches
need
to
be
modified
so
that
simply
having
a
website
and
asking
people
to
go
to
the
website
or
distributing
leaflets
may
not
be
adequate.
We
need
to
use
targeted,
directed
messages
and
trusted
messengers,
so
it's
really
really
critical
to
address
institutional
mistrust
as
opposed
to
automatically
just
saying
they
don't
want
to
participate
and
then
moving
on.
B
This
is
the
specific
example
I
wanted
to
share
with
you,
I'm
showing
you
data
from
the
moderna
phase,
3
vaccine
trial,
the
most
recent
four
weeks
from
august
31st
through
last
week,
september
21
and
the
example
here
is
prior
to
august,
meaning
the
first
four
weeks
after
launch.
The
proportion
of
african
americans
enrolling
showing
in
blue
was
only
four
or
five
percent.
B
Hispanics
was
only
around
10
percent,
so
it
was
very
low.
They
did
all
the
right.
Things
began:
engaging
using
appropriate
public
service
announcements,
appropriate
targeted
messages
using
trusted
voices
in
the
communities
and,
in
the
last
four
weeks,
you've
seen
the
gradual
increase
african-americans
going
from
five
percent
in
july
to
9
10.
B
Actually,
the
african-americans
shown
in
blue
and
most
recently,
almost
30
of
in
the
last
week
of
sampling,
same
thing
for
hispanics
went
from
under
10
to
17.
23
31
was
recently
42.
So
when
you
take
the
right
steps
and
you
use
the
right
and
appropriately
targeted
engagement
and
outreach,
you
can
have
success
in
recruiting
and
african-americans.
B
B
The
two
main
objectives
are
to
use
strategies
that
have
been
shown
to
be
effective
in
community
engagement
and
outreach
that
we
can
specifically
target
misinformation
and
mistrust
and
promote
and
facilitate
inclusion
in
clinical
trials
in
the
next
slide.
I
just
want
to
show
you
to
make
it
easier
for
those
who
want
to
access
information,
putting
as
much
of
our
trusted
information
in
one
place
as
possible.
One
single
website.
B
Covet19Community.Nih.Gov
and
you
get
access
to
all
the
information
that
we
have
available.
In
addition,
we've
leveraged
all
the
years
of
experience
from
hiv
vaccine
trials,
other
vaccine
trials
and
other
infectious
disease
trials
to
put
together
the
covet
19
prevention
network.
This
is
their
website
shown
in
the
bottom
right
and
they
provide
similarly
very
useful
information,
as
well
as
an
opportunity
for
individuals
to
volunteer
for
the
research
I'll
finish
up
by
dwelling
on
this
slide
for
just
a
minute,
because
this
is
critical,
we
know
there
is
a
lot
that
ncsl
can
do
as
you
as
individuals.
B
State
legislators,
as
well
as
your
legislatures,
can
do
definitely
highlighting
the
mechanisms
we
have
in
place
at
the
state
level,
as
well
as
the
federal
level
that
ensures
safety
and
emphasize
that
safety
is
the
number
one.
Priority
is
key.
All
of
you
are
trusted
voices
in
your
community
and
we
need
your
help
to
emphasize
the
importance
of
this
work.
B
These
communities
that
have
been
hard
as
this
doing
all
you
can
to
engage
them
in
this
effort
would
be
really
really
worth
it.
Certainly
supporting
policies
and
legislation
in
your
state
that
are
based
on
scientific
evidence
would
be
crucial
and
helping
us
all
work
together
to
promote
health
equity
for
all
and
address
structural
racism
and
all
forms
of
institutionalized
discrimination
and
barriers
that
stand
in
the
way
of
participation
would
be
crucial.
B
This
final
slide
provides
several
of
the
links
that
can
lead
to
trustworthy
information.
All
of
you
you're
paying
the
taxpayers
dollars
that
support
us,
and
we're
very
grateful
for
that.
So
these
are
the
sources
I've
listed
for
nih
as
well
as
cdc,
and
you,
of
course
know
of
other
sources
of
trustworthy
information.
B
So
I
will
stop
there
and
say
if
you
need
more
detailed
information
on
diversity
in
clinical
trials.
The
fda
has
a
wonderful
resource,
here's
the
website.
It
provides
at
least
the
last
three
to
five
years
of
how
we're
doing
in
diversity
and
drug
trials
and
at
nih
we
also
provide
on
the
right
side.
I've
shown
you
the
web
link
that
tells
you
about
how
we
do
in
the
research
we
fund
in
terms
of
inclusion
of
women
and
minorities,
as
well
as
inclusion
of
individuals
across
the
lifespan
and
I'm
going
to
stop
there.
B
A
I
do
want
to
invite
any
of
our
participants
to
use
the
chat
function,
to
submit
any
questions
so
right
now
we
are
going
to
go
to
our
next
speaker.
We
have
audrey
sunivassian
he's
the
head
of
global
development
operations
at
novartis.
Audrey
has
more
than
25
years
of
experience
in
clinical
trial,
design
and
execution.
A
Audrey
works
on
removing
obstacles,
fostering
innovation
and
data-driven
decision-making
and
harnessing
the
collective
energy
of
teens
for
effective
collaboration.
Much
of
his
work
has
been
on
challenging
and
disrupting
assumptions
and
ways
of
working
better
to
serve
patients.
He
has
worked
in
the
industry
with
over
25
years
of
experience
audrey.
Thank
you
so
much
for
joining
us
today.
The
floor
is
now
yours.
C
Thank
you
very
much
sydney
and
thank
you,
dr
mensa,
for
a
fantastic
presentation.
I
will
attempt
to
build
on
dr
mensa's
presentation
and
provide
a
little
bit
more
color
into
clinical
trials
challenges,
addressing
diversity
and
then,
obviously,
looking
for
all
of
your
help.
It's
delighted
to
be
here
delighted
to
be
with
you
all
very
important
group.
You
have
a
lot
of
influence
and
can
indeed
influence
a
lot
in
how
we
not
only
do
clinical
trials,
but
do
good
with
clinical
trials
with
the
right
population.
C
In
there
the
flow
of
my
presentation,
I
will
introduce
a
little
bit
of
novartis
to
you
and
then
also
the
particular
division
that
I
run,
which
runs
all
the
clinical
trials
in
novartis
global
development
operations.
Talk
to
you
a
little
bit
about
challenges
in
running,
recruiting
clinical
trials
and
also
from
a
diversity
perspective.
C
Talk
a
little
bit
about
our
covet
response.
How
novartis
responded
to
covet?
We
will
give
you
a
little
bit
of
a
snapshot
into
how
companies
like
us
responded
to
covet
what
we
are
doing
about
diversity,
which
also
then
bring
approaches
a
broader
topic
of
diversity
and
then,
hopefully,
will
end
with
seeking
your
help
and
participation
going
forward.
C
We
go
to
the
next
slide.
Let
me
use
this
to
introduce
novartis
novartis
is
we
are
one
of
the
largest
pharmaceutical
companies
in
the
world?
I'm
sure
you
all
have
heard
about
it.
We
have
a
pretty
broad
and
diverse
portfolio
of
medicines
that
we
develop
at
any
given
point
in
time
as
of
right
now,
for
example,
we're
in
about
50
different
disease
areas
addressing
unmet
need
in
those
50
different
disease
areas
in
the
u.s
we
have
about
15
000
associates
who
work
in
novartis.
C
We
invest
somewhere
of
the
order
of
about
four
billion
dollars
annually
globally
in
research
and
development,
all
towards
finding
medicines
towards
finding
cures,
and
we've
supported
over
about
a
half
a
million
patients
to
our
co-pay
assistance
program.
That's
just
a
broad
brush
of
novartis
and
some
key
statistics.
There.
C
C
Spent
a
lot
of
time
in
the
u.s
I'm
now
based
in
basel
switzerland,
which
is
the
headquarters
of
novartis,
but
20
plus
years
of
my
life,
was
spent
in
the
us,
primarily
in
raleigh
north
carolina,
where
I
went
to
school
and
then
subsequently
worked
in
a
number
of
companies
over
there.
This
essentially,
hopefully
gives
you
a
frame
for
what
novartis
is
and
what
the
particular
division
that
I
run
in
novartis
is.
C
If
you
go
to
the
next
slide,
I
want
to
key
off
of
what
dr
mensah
said.
Clinical
trials
are
a
pretty
complicated
set
of
activities.
Drug
development
in
general
is
a
trial
and
error
activity.
We
know
a
lot
about
the
human
body
and
the
biology
of
the
human
body,
but
yet
what
we
know
is
very
little
of
what
there
is
to
know
and
every
day
new
discoveries
every
day
we're
finding
out
more
and
inherent
to.
C
That
is
the
challenge
of
running
clinical
trials,
and
I
want
to
showcase
you
some
of
the
trial
and
recruitment
challenges,
because
that
can
then
juxtapose
against
the
particular
challenges
of
diversity.
We
have
and
probably
adds
a
little
bit
more
color
to
that
as
well,
typically
from
beginning
to
end
from
when
something
enters
phase,
one
as
as
dr
mensah
showed
in
his
slides
two
when
it
goes
for
registration,
gets
approved,
phase
three
and
then
for
approval
to
the
fda
can
be
a
long
time.
C
If
I
look
at
just
some
of
the
statistics
here
from
a
trials
perspective,
tufts
university
does
repeat
analysis.
The
number
of
analysis
on
how
clinical
trials
are
executed,
how
productive
they
are
et
cetera,
et
cetera
in
2020
tufts
analysis,
found
that
the
average
time
to
conduct
studies
increased
by
about
five
months
compared
to
the
previous
periods
of
2008-2013
or
2014
to
18.,
and
this
is
despite
regulatory
approval
process,
actually
getting
shorter.
So
on
the
one
hand
we
have
the
regulators
being
very
efficient
at
what
they
do
are
getting
more
and
more
efficient.
C
If
you
look
at
the
recruitment
side,
on
the
other
hand,
of
all
of
the
patients
eligible
to
participate
in
trials
somewhere
between
two
and
five
percent
of
patients
actually
participate
in
trials.
Now,
this
is
pertinent,
because
the
more
we
increase
diversity
in
trials,
the
more
we
go
to
populations
that
we
are
today
not
including
in
trials.
The
more
is
our
ability
to
not
only
conduct
the
right
child,
but
also
have
more
participants
into
to
the
trial.
C
As
you
look
at
the
amount
of
u.s
trials
that
fail
to
meet
their
recruitment
deadlines.
80
percent
of
trials
today,
in
one
way
shape
or
form
do
not
actually
meet
their
original
commitment
of
of
timelines
or
or
recruitment
goals.
If
you
will,
which
again
contributes
to
that
five
months,
increase
that
we
are
seeing
in
time
to
conduct
a
study.
C
So
the
reason
I
wanted
to
share
some
of
these
statistics
with
you
is
to
to
underscore
the
fact
that
it
is
a
a
pretty
complex
environment
that
we
are
getting
into
and
then
into
this
environment.
If
you
will,
we
have
a
situation
of
diversity.
That
is
not
right
as
well
as
dr
menses.
It
african
americans
constitute
about
13
and
a
half
to
14
of
the
population,
but
less
than
9
actually
participate
in
trials.
C
C
So
we
know
that
minority
groups
not
only
are
underrepresented
in
trials,
but
they
also
have
a
different
expression
of
the
disease
which
we
need
to
study,
and
we
need
to
understand
why
that
is
the
same.
If
you
look
at
asthma,
for
example,
you
have
in
the
same
population,
if
you
take
mortality
rates
for
regular
asthma
patients
and
the
rate
for
children,
it's
ten
times
higher.
C
Otherwise,
we
have
a
situation
where
we
have
drugs
that
get
approved,
and
perhaps
we
think
that
it
is
applicable
to
the
population
when
it
may
not
be,
and
then
we
have
marketing
safety
concerns.
We
have
post
marketing
investigations.
We
need
to
do
et
cetera,
post
marketing
investigations
being
investigations
done
after
the
drug
gets
approved,
so
that
gives
you
a
little
bit
of
a
flavor
and
not
just
on
the
challenges
on
the
recruitment
and
on
the
diversity.
Now,
in
addition
to
this
I'll
say
one
more
point
before
I
move
to
the
next
slide.
C
In
addition
to
this,
if
you
look
at
the
cost
of
clinical
trials,
the
cost
of
clinical
trials
has
pretty
much
gone
up
substantially.
In
2003,
the
total
cost
of
bringing
a
medicine
to
patients
was
about
800
million
in
2018
that
same
number,
the
same
figure
stood
at
2.6
billion,
800
million
2.6
billion,
again
undisclosed.
The
fact
that
we
need
to
look
at
this
challenge
in
a
very
different
way
and
look
at
this
in
a
very
inclusive
way
going
to
the
next
slide.
C
We
joined,
for
example,
the
active
public-private
partnership
that
nih
helped
put
in
place
as
part
of
the
nih
efforts
to
to
to
look
at
covert
and
combat
coding.
The
bill
and
melinda
gates.
Therapeutic
accelerator
was
put
in
place
and
we
joined
that
as
well,
as
did
many
pharmaceutical
companies
to
come
together
to
collaborate
on
how
we
could
respond
to
the
covet
pandemic.
C
University
of
california
berkeley
put
together
a
collaborative
drug
discovery,
effort
which
again
a
number
of
pharmaceutical
companies,
including
novartis
joined
for
us.
In
addition,
we
made
launch
a
not-for-profit
for
portfolio
of
medicines
or
our
15
generics
that
we
had
through
our
sandoz
division
and
tried
and
made
that
available
for
low
and
lower
middle-income
countries.
C
Now
from
a
clinical
trials
perspective,
what
we
wanted
to
do
was
make
sure
that
we
looked
at
our
portfolio
of
of
medicines
that
we
had
of
therapies.
We
had
and
tried
to
understand
what
is
the
ones
that
could
actually
help
with
the
covet
pandemic
and
bring
that
to
clinical
trials
and
bring
that
to
an
approval
pathway
as
fast
as
possible.
C
C
These
were
areas
we
went
into
deliberately
to
ensure
that
our
representation
of
of
diversity
in
these
in
the
clinical
trials
was
was
good,
robust
and
appropriate.
We
also
took
steps
to
ensure
that
the
site
personnel
that
were
involved
in
the
clinical
trials
also
had
not
only
diversity
but
also
a
good
background
and
a
diverse
background.
We
had
40
female
clinical
investigators,
21
of
which
were
non-white
and
32
of
the
males
were
non-white
as
well.
That
was
important
because
it
was
important
as
again
dr
mensah
mentioned.
There
is
a
trusting,
trustworthy
environment.
C
C
These
were
some
of
the
ways
in
which
we
tried,
with
a
focus
on
covid,
increased
participation
going
to
the
next
slide.
I
have
a
couple
of
slides
and
I'm
going
to
stop
in
the
interest
of
time,
because
we
want
to
preserve
some
time
for
questions
and
answers
as
well.
Our
efforts
at
diversity
and
inclusion
essentially
falls
into
four
buckets.
C
Partnerships
allow
us
to
do
more
effectively.
What
no
single
organization
can
do.
Things
like
investigator
training
things
like
building
common
recruitment
methodologies
reaching
into
and
creating
these
trustworthy
entities
trustworthy
folks
with
appropriate
training
who
can
go
into
the
communities
and
enroll
these
patients.
When
we
take
a
partnership
approach,
we
feel
that
is
much
more
strengthened
and
it
becomes
a
voice
of
the
entire
population
rather
than
a
single
pharmaceutical
company
trying
to
do
something.
C
So
we
believe
a
lot
in
these
strategic
partnerships
and
have
invested
a
lot
and
continue
to
invest
a
lot
in
these
strategic
partnerships,
data
and
technology.
As
with
anything
else,
it
is
important
for
us
to
understand
what
is
the
problem
we're
facing?
The
data
allows
us
to
go
in
with
appropriate
interventions,
understand
what
is
the
population
prevalence,
what
should
be
the
representation
of
african
americans
of
hispanics,
etc
and
then
to
understand?
How
do
we
at
least
meet
the
population
prevalence
in
our
clinical
trials?
C
We
use
a
strategy
which
is
a
gender
health
equity
strategy
to
understand
how
we
need
to
go
and
how
we
need
to
populate
these
trials.
We
have
a
tool
called
map
of
life
which
we've
built,
which
allows
us
very
quickly
for
any
given
protocol
for
any
given
program.
A
disease
program
understand:
where
should
we
go
and
how
should
we
recruit
these
patients?
C
Now?
That's
all
great!
It
only
comes
to
life
if
we
actually
practice
it
every
day
and
there
therein
lies
the
processes
and
tools.
What
we
are
doing
actively
is
embedding
each
of
these
interventions
into
how
we
conduct
clinical
trials
just
day
to
day.
Diversity
is
not
a
special
thing.
We
should
do
every
other
week
or
on
fridays
of
the
last
friday
of
the
month
or
anything
special.
It
should
become
part
of
the
fabric
of
how
we
do
clinical
trials
and
embedding
it
into
our
process.
C
On
the
last
slide,
let
me
let
me
stay
on
this
for
for
a
minute
when
covid
came
before
code,
I
would
I
would
put
it
this
way.
Many
of
our
actions
in
clinical
trials
were
dictated
by
policy
policies
such
as
gcp
policies,
policies
such
as
the
guidance
documents
issued
by
the
various
regulatory
authorities.
C
C
If
we
needed
to
do
telemedicine,
we
just
had
to
do
it
to
ensure
the
safety
of
patients
to
ensure
that
we
serve
the
patient
community
well
and
many
times,
policies
caught
up
after
the
fact
to
the
practices
that
happened
on
the
ground
as
a
result
or
because
of
coving,
but
what
it
showcased
was.
The
policy
limitations
that
we
were
saying
was
simply
artificial.
C
Where
there
is
a
will,
we
actually
can
make
things
happen,
and
the
regulators
also
saw
that
there
was
a
way
in
which
we
could
be
very
agile
with
the
way
we
do
this
with
how
we
practice.
As
long
as
we
are
doing
it
within
certain
bounds
and
within
certain
norms-
and
we
can
work
together
that
it's
not
policy
or
practice,
but
it's
actually
policy
and
practice
working
together
to
achieve
many
of
these
solutions,
I
believe
we
are
at
a
similar
inflection
point
with
regards
to
diversity.
C
Diversity
is
not
something
we
do
and
then
afterwards
claim
or
diversity
is
not.
Something
we
say
is
a
problem
and
then
find
solution,
diversity
and
how
we
do
this
in
clinical
trials
has
to
become
part
of
the
fabric
of
how
we
think
about
it.
How
we
design
trials,
how
we
execute
trials,
and
it
has
to
be
done
collaboratively
just
like
pharmaceutical
companies
and
regulators,
join
together
from
a
covet
perspective.
C
I
believe
the
power
of
that
is
when
we
do
that,
together,
we're
able
to
travel
further
travel
faster,
put
in
more
lasting
solutions,
put
in
more
solutions
that
really
are
meaningful
on
the
ground,
and
I
think
that's
what
we're
committed
to
that's
what
I'm
personally
committed
to,
and
I
can
say
with
all
with
all
clarity
that
that's
what
novartis
is
committed
to
as
well.
Thank
you
very
much
for
the
time.
Thank
you
for
listening.
Listening
to
this
presentation
and
thanks
for
the
opportunity
to
be
here
with
you
all
today,
back
over
to
you.
A
A
We
have
a
few
already
in
the
chat
box.
One
question
is
for
dr
mensah
on
your
slide
slide.
19
about
what
can
ncsl
and
state
legislators
do.
It
would
be
great
to
drill
down
on
more
of
an
action
plan
and
resources
to
address
the
areas
that
you
reference
on
that
slide.
Do
you
have
anything
else
to
add
dr
mensah
like?
If
a
state
legislator
wants
to
be
more
involved
in
the
process,
how
would
you
recommend
they
get
started
or
who
should
they
reach
out
to
in
their
state.
B
City,
thank
you
very
much.
I
think
that's
a
very
important
question.
We
always
we're
happy
when
we
see
actions
follow
discussions
to
the
extent
that
we
get
approval
we'll
be
delighted
to
work
with
you.
I
think
the
process
would
be
maybe
a
letter.
If
you
send
a
letter
to
me
I'll,
be
happy
to
direct
it
to
our
office
of
policy
and
legislation,
they
would
get
the
appropriate
approval
and
we
can
certainly
work
on
this.
B
Dr
francis
collins
has
made
it
very
clear
that
this
is
an
all
hands
on
deck
effort.
Obviously,
there's
a
great
deal
of
benefit
from
working
together
and
I'll
be
delighted
to
follow
up.
If
you
send
an
email,
either
through
sydney
or
through
hhs
or
to
nih,
it
would
get
to
me
I'm
one
of
two
staff
who
are
co-leading
the
seal
effort
and
that's
ceal
as
a
community
engaged
alliance
against
covet
19
disparities.
A
B
A
B
In
in
addition,
we
recognize
that
it's
very
challenging
frankly,
because
every
company
has
access
to
its
own
real-time
data.
You
have
to
go
to
every
company's
website
to
get
that.
The
good
news
is
the
nih
funded
covet
19
prevention
network.
Again,
it's
called
vpn
ceo
vpn.
If
you
google,
that
you
get
that
they're
working
on
trying
to
put
together
a
one
website
where
you
can
go
and
have
access,
I
know
that
moderna
has
a
site
and
it's
modern
tx.
B
C
Thanks
dr
mentor,
just
two
other
points
for
to
the
to
the
great
information
already
provided
by
documentary.
One
is
you
could
go
to
clinic
clintonchilds.gov,
which
is
the
fda
website,
and
it
has
a
repository.
All
pharmaceutical
companies
register
any
trial
that
they
start
at
that
website
and
it'll
tell
you
what
the
status
of
this
trial
is
as
well
is
it
recruiting?
Is
it
closed?
Is
it
just
opening?
Where
is
it
which
countries
which
states
etc?
So
that
is
another
great
source
of
information?
C
Very
easy
to
use,
got
a
lot
of
filters,
search
capabilities,
etc.
There's
a
second
part
of
that
question:
is
it
possible
to
know
how
they're
working
before
the
trial
finishes?
Let
me
answer
in
general
in
any
clinical
trial.
These
days
we
have
what
are
known
as
interim
analyses.
Interim
analysis
could
be
for
a
number
of
reasons
they
predominantly
either
predominantly
actually
for
ensuring
that
there
is
no
safety
concern.
A
C
Efficacious
and
we
need
to
stop
it
because
it
makes
no
sense
for
people
to
let's
say
continue
on
a
placebo
or
a
comparator
when
we
actually
have
evidence
of
efficacy,
then
that
is
one
way
to
find
out
now.
This
is
in
general.
Not
all
trials.
Have
this
but
I've
given
this
as
a
general
information
sydney
back
to
you,.
B
B
So
when
it
says
60
to
100,
depending
on
the
trial
for
phase
one,
they
may
use
60
people.
Another
may
use
a
hundred,
but
usually
that
range
tends
to
be
accurate.
So
if
you
look
at
the
phase
three
trial,
for
example-
and
this
is
actually
a
very
important
question
for
the
moderna
trial,
if
you
look
on
my
slide-
and
we
say
several
hundreds
to
several
thousand-
there
could
be
a
phase
three
trial.
B
So,
instead
of
enrolling
a
thousand
people,
if
you
enroll
30
000
people,
meaning
you
have
the
resources
to
do
that,
you
may
not
have
to
wait
three
years,
but
you
could
get
enough
events
in
just
one
year.
So
the
two
part
answer
is
the
numbers
are
approximate,
but
in
general,
if
you
have
the
resources,
you
can
enroll
a
whole
lot
more
and
you're
likely
to
get
results
faster.
That
is
how
we
are
able
to
accelerate
the
vaccine
covet
19
vaccine
trials
without
sacrificing
safety.
A
A
I
would
again
like
to
thank
novartis
for
their
support
of
this
webinar
and
thank
you
to
our
attendees
for
participating
in
today's
webinar.
As
a
reminder
of
the
recording
of
today's
webinar
and
the
slides
will
be
available
on
ncfl's
website
within
the
week.
Thank
you
very
much
for
attending
and
hope
you
all
have
a
great
day.