This document summarizes a presentation on translational research given to the Wisconsin Health Science Librarians Association. It defines translational research as research that facilitates moving findings from basic science into practical applications to improve human health. It discusses how clinical and translational research centers (CTSAs) were established by the NIH to help re-engineer the clinical research enterprise and speed the translation of research results. CTSAs work to build infrastructure, support innovative research, and provide education and training across 60 centers nationally.

1. Transla'onal
Research:
Hastening
Research
Results,
Reducing
Research
Fraud,
Protec'ng
Pa'ents
and
the
New
Importance
of
Research
Data
Wisconsin
Health
Science
Librarians
Associa'on
Annual
Mee'ng
–
September
21,
2012
Dorothea
Salo
UW-­‐Madison
School
of
Library
&
Informa'on
Science
Allan
Barclay
UW-­‐Madison
Ebling
Library
for
the
Health
Sciences

2. Class
Outline
! Introduc'ons
! Background:
What
is
Transla'onal
Research?
! Break
! Save
the
Cows!
! Break
! How
Librarians
Can
Help/Discussion/Q&A

3. Transla'onal
Research
"Transla'onal
research
is
scien'fic
research
that
facilitates
the
transla'on
of
findings
from
basic
science
to
prac'cal
applica'ons
that
enhance
human
health
and
well-­‐being.
It
is
prac'ced
in
the
medical,
behavioral,
and
social
sciences.”
Source:
Wikipedia,
accessed
9/19/12

4. Clinical
Research
“Clinical
research
is
a
branch
of
medical
science
that
determines
the
safety
and
effec'veness
of
medica'ons,
devices,
diagnos'c
products
and
treatment
regimens
intended
for
human
use.
These
may
be
used
for
preven'on,
treatment,
diagnosis
or
for
relieving
symptoms
of
a
disease.
Clinical
Research
is
different
than
clinical
prac'ce.
In
clinical
prac'ce,
one
used
established
treatments
while
in
clinical
research
evidence
is
collected
to
establish
a
treatment.”
Source:
Wikipedia,
accessed
9/19/12

5. Clinical
+
Transla'onal
Research
! Basic
research
! Specula've
! Long
term,
big
picture
! Scaershot
or
uncoordinated
! Can
lead
to
major
breakthroughs,
paradigm
shi^s
! Applied
research
! Prac'cal
! Short
term,
here
&
now
impact
! Incremental
! Clinical
+
Transla'onal
=
basic,
applied
+
evalua'on
and
follow-­‐up

6. So
Why
Change
Anything?
Houston,
we
have
a
problem
“…need
to
s'mulate
the
development
of
novel
approaches…”
“…reduce
cultural
&
administra've
barriers…”
“…clinical
research
was
increasingly
less
aErac've
to
new
inves'gators…”
“…clinician-­‐scien'sts
were
increasingly
moving
away
from
pa'ent-­‐oriented
research…”
Source:
"Transla'onal
and
Clinical
Science
-­‐
Time
for
a
New
Vision"
-­‐
Elias
A.
Zerhouni,
director
NIH;
NEJM,
335.15,
October
13,
2005,
p.
1621-­‐1623

7. But
Change
is
Hard!
Houston,
we
really
have
a
problem
here
“…difficul'es
in
the
recruitment
&
reten'on
of
human
subjects
in
clinical
trials…”
“…increasingly
complex
resources
needed
to
conduct
modern
clinical
and
transla'onal
research
are
either
missing
or
scaEered…”
“…their
interac'ons
were
becoming
more
remote
and
difficult…”
Source:
"Transla'onal
and
Clinical
Science
-­‐
Time
for
a
New
Vision"
-­‐
Elias
A.
Zerhouni,
director
NIH;
NEJM,
335.15,
October
13,
2005,
p.
1621-­‐1623

8. OK,
You
Win
–
We’ll
Change
The
3rd
Roadmap
Theme:
Re-­‐engineering
the
Clinical
Research
Enterprise
Source:
hp://www.starshipdatalink.net/enterprise/1701-­‐refit.html

9. New
Funding
Models
–
the
CTSA
Timeline
! 2003
–
NIH
Roadmap
for
Medical
Research
! 2006
–
CTSA
program
launched
by
NIH
! 2007
–
UW
ICTR
founded,
one
of
12
centers
! 2009
–
Program
expands
to
46
centers
! 2011
–
NCATS
established
to
coordinate
CTSA
awards
! 2012
–
Full
implementa'on
of
60
centers;
Miami
CTSI
just
added
(61)

10. CTSA
Centers
Source:
hp://www.ncats.nih.gov/research/cts/ctsa/about/ins'tu'ons/map.html

11. How
are
they
organized?
• Not
the
800
lb
gorilla
–
they
complement,
don’t
compete
with
exis'ng
infrastructure
– UW-­‐ICTR
&
Marshfield
Clinic,
United
Community
Center
– WREN
– TEAM
Scholars
program
(cohort
prior
to
KL2
scholars)
– Miami
CTSI
–
funding
from
NCATS
&
Nat’l
Ins'tute
on
Minority
Health
and
Health
Dispari'es
• Each
center
is
unique
–
no
common
structure,
only
common
goals
• Transforma'onal
goals
è
dynamic
structure

12. What
do
they
do?
• Research,
of
course
–
with
specific
targets
– This
year
is
all
about
drug
development
– Novel,
innova've
approaches
– Too
risky,
too
rare
for
private
sector
support
– Exis'ng
local
research
programs
– Exis'ng
popula'ons
• Build,
grow,
strengthen,
standardize
infrastructure
• Educa'on
&
professional
development

13. Types
of
Transla'onal
Research
T1
–
First
phase
of
transla'onal
research,
or
“Bench
to
Bedside,”
moves
a
basic
discovery
into
a
clinical
applica'on
T2
–
“Bedside
to
Prac'ce”
research
provides
evidence
of
the
value
of
taking
the
basic
discovery
in
the
clinical
setng
T3
–
Research
that
moves
the
evidence-­‐based
guidelines
developed
in
phase
2
into
health
prac'ce;
“Prac'ce
to
Profession”
T4
–
Research
to
evaluate
the
“real
world”
health
outcomes
of
the
original
T1
development;
“Profession
to
Public”
Adapted
from:
hp://www.michr.umich.edu/about/clinicaltransla'onalresearch

14. Type
1
Example:
Experimental
Mul'ple
Sclerosis
Drug
BG-­‐12
! Biogen
Idec
licenses
rights
to
develop
drug
in
2003
! Clinical
trials
are
ini'ated

15. Type
2
Example:
Experimental
Mul'ple
Sclerosis
Drug
BG-­‐12
! Clinical
trials
show
promise,
few
side
effects
–
given
Fast
Track
designa'on
by
FDA
! News
media
promote
the
drug
discovery
! Business
media
promote
the
company’s
good
fortune

16. Type
3
Example:
Experimental
Mul'ple
Sclerosis
Drug
BG-­‐12
! If
approved
will
likely
be
widely
prescribed
quickly
–
recent
research
shows
current
therapies
are
largely
ineffec've,
leaving
a
void
in
treatment
! Rapid,
widespread
adop'on
combined
with
high
public
profile
&
large
number
of
pa'ents
will
likely
lead
to
its
inclusion
in
clinical
prac'ce
guidelines
! Prac'ce
guidelines
will
lead
to
changes
in
clinical
educa'on
as
well
as
prac'ce

17. Type
4
Example:
Experimental
Mul'ple
Sclerosis
Drug
BG-­‐12
! Clinical
prac'ce
guidelines
will
drive
use
in
the
profession,
providing
a
much
wider
basis
for
evalua'on
of
effec'veness
and
results
! Pa'ents
taking
BG-­‐12
will
be
recruited
for
follow-­‐up
studies
! Impact
“in
the
field”
will
be
assessed
! Based
on
results
new
drug
development
may
occur
to
respond
to
observed
issues
(e.g.
side
effects,
ineffec'veness
in
some
popula'ons)

18. How
is
it
different
from
tradi'onal
medical
research?
! Complete
lifecycle
research
–
T1
è
T4
è
T1
! Emphasis
on
public
health,
health
outcomes
! Emphasis
on
mul'disciplinary
research
! Emphasis
on
health
equity,
underserved
popula'ons
! Fills
in
the
gaps
in
tradi'onal
research
prac'ce
and
infrastructure
! Aempts
to
create
a
transparent
scien'fic
environment

19. A
Structural
Metaphor
-­‐
Pace
Layering
“The
fast
parts
learn,
propose,
and
absorb
shocks;
the
slow
parts
remember,
integrate,
and
constrain.
The
fast
parts
get
all
the
aEen'on.
The
slow
parts
have
all
the
power.”
Source:
Brand
S.,
"Ci'es
and
Time",
The
Long
Now
Founda'on
hp://blog.longnow.org/2005/04/11/stewart-­‐brand-­‐ci'es-­‐and-­‐'me/

20. Pace
Layering
Elements
! The
lessons
learnt
and
changes
that
occur
at
the
outer
layers,
where
change
happens
the
fastest,
filter
down
to
the
inner
layer
where
change
happens
slowly
! The
differing
rates
of
change
in
each
layer
are
likely
to
cause
fric'on
between
the
layers
! The
different
rates
of
change,
and
resolving
the
resul'ng
fric'on,
are
beneficial
to
the
overall
development
of
complex
systems
Source:
The
Evolving
Web:
A
Pace
Layering
view
of
the
development
of
the
Web
and
the
WC3,
Roger
Hudson,
hp://www.usability.com.au/resources/evolving-­‐web.cfm

21. The
Research
Enterprise
-­‐
Layers
! Starfleet
! Funding
agencies
! Research
ins'tu'ons
! Researchers
! Publishers
and
other
disseminators
! Professional
socie'es
(prac'ce
guidelines,
accredita'on)
! Clinicians
! The
public

22. Why,
yes,
I
am
a
hopeless
op'mist!
Source:
hp://dollydileante.blogspot.com/2007/10/all-­‐about-­‐pollyanna.html

23. End
Part
I

24. Part
III
–
Opportuni'es
for
Librarians

25. The
tradi'onal
! Lit
searching
–
general
&
now
for
compliance
issues
! Database
exper'se
! Reference
&
instruc'on
! Current
awareness
services
(RSS,
TOC,
etc.)

26. Scholarly
communica'on
! PMCID,
NIHMSID,
grant
numbers
&
acknowledgment
! Repositories
! Journal
publica'on
selec'on
! Open
Access
issues

27. Altmetrics
! Twier
! Blogs
! Social
literature
tools
-­‐
Mendeley,
Papers
! News
sources

28. Clinical
trials
! Clinicaltrials.gov
&
the
usual
suspects
! Local
clinical
trials
–
recrui'ng,
lis'ngs
! Cohort
selec'on
! hp://i2b2.org
-­‐
Informa'cs
for
Integra'ng
Biology
and
the
Bedside
! Taxonomy
development
done
by
librarians!
Who
look
like
Lisbeth
Salander!

29. Funding
! Finding
sources
of
funding
! Grants.gov
! Non-­‐governmental
sources
(e.g.
founda'ons,
programs)
! Local
sources
(e.g.
healthcare
ins'tu'ons,
CTSA
centers)
! Help
with
grants
(background
research,
data
plans)

30. Informa'cs
! Electronic
medical
records
! Tools
to
help
(semi)
automate
other
tasks
like
publica'on
tracking,
finding
funding,
etc

31. “CTSA
Ins'tu'onal
Navigator”
! Crappy
website
figurer-­‐outer
! Matchmaker
! Neutral
3rd
party
! Ins'tu'onal
memory

32. Educa'on
&
Awareness
! CTSA
center
opportuni'es
–
finding
and
promo'ng
! Library
instruc'on
! Research
data
issues
&
awareness

33. And
now
for
something
completely
different…