NIH Review and Funding of
Clinical Research
Norka Ruiz Bravo, PhD
Deputy Director for Extramural Research
NIH/DHHS
Clinical Research Forum
26 April 2006
Today’s conversation
• Part I
– Starting from the same page…
• Part II
– Hypothesis
– Definitions and methods
– Presentation order for data
– Data
• Part III
– Conclusions
The Basics
• NIH separates the technical and scientific
merit review of applications from funding
• Peer review panels conduct reviews
• Funding decisions are made by Institutes
and Centers
• CSR reviews ~70-75% of NIH applications;
~ 50% of dollars
• Trans-NIH peer review policy – OER
responsibility
Part II
Review and Award of NIH Grants
for Clinical Research
• Hypothesis
– Clinical research grant applications have
lower success rates* than basic research
applications
– Success rate correlates with locus of review
* SR = Number of applications funded
Number of unique applications reviewed
Definitions (1)
• Clinical Research:
– Patient-oriented research. Research conducted with
human subjects (or on material of human origin such
as tissues, specimens and cognitive phenomena) for
which an investigator (or colleague) directly interacts
with human subjects. Excluded from this definition
are in vitro studies that utilize human tissues that
cannot be linked to a living individual. Patient-
oriented research includes: (a) mechanisms of
human disease, (b) therapeutic interventions, (c)
clinical trials, or (d) development of new
technologies.
– Epidemiologic and behavioral studies.
– Outcomes research and health services research.
Definitions (2)
Research Grants: Research grant mechanisms employed in
FY 2005 (Distributed to Budget Categories and Reporting
Groups)
• Research Project Grants
• Research Project Grants: DP1, P01, P42, PN1, R01, R03,
R15, R21, R29, R33, R34, R36, R37, R55, R56, U01, U19, UC1
• Small Business Grants: R43, R44, U43, U44, R41, R42
• R01 Equivalent Grants: R01, R23, R29, R37
• Research Centers
– Research Center Grants: G12, M01, P20, P30, P40, P41, P50,
P51, P60, U41, U42, U54
• Research Careers (Mentored and Other)
• Other Research (excluding research careers)
– Other Research Grants
R&D Contracts
Definitions (3)
• Human subjects (HS+) applications
– For the analyses shown, involvement of human
subjects (HS+) is used as a surrogate for clinical
research.
– Records employing coded human specimens and
information (Exemption 4) are included in the non-
human subjects research category
• How good a surrogate for clinical research is
HS+?
– $8.7 Billion is NIH Office of Budget estimate for
clinical research (FY2005)
– $9.6 Billion is HS+ (FY2005)
Presentation order for data
#
Number Applications
HS+
reviewed HS- HS+ HS-
Success rt. Success rt.
CSR # Awards # Awards
$ Awarded $ Awarded
CSR Locus IC
Review Review
of Success rt. Success rt.
review IC # Awards # Awards
$ Awarded $ Awarded
HS+
HS- HS+ HS-
Success rate
Research Grants (FY 2005)
RG Applications
Total
55,546 Applications
21.32 HS+ (38%)
34,244 HS- (62%)
Locus of Review
CSR IC
42,124 Applications 13,422 Applications
13,926 HS+ (33%) 7,376 HS+ (55%)
28,198 HS- (67%) 6,046 HS- (45%)
Awards
HS+ HS- HS+ HS-
2,624 Awards 6,705 Awards 1,912 Awards 2,128 Awards
Success Rate 19% Success Rate 24% Success Rate 26% Success Rate 35%
Human Subjects Research Grant Applications Reviewed in CSR and ICs with Success
Rates
16,000 CSR HS+ Applications 50%
CSR HS+ Awards
14,000 IC HS+ Applications
IC HS+ Awards
CSR HS+ Success Rate 40%
12,000 IC HS+ Success Rate
10,000
30%
Success Rate
Number
8,000
20%
6,000
4,000
10%
2,000
- 0%
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
Number of Research Grant Awards involving or not involving Human Subjects by Locus
of Review Compared to NIH Appropriations (FY 1996 to 2005)
8,000 $30.0
CSR HS+ Awards
CSR HS- Awards
7,000 IC HS+ Awards
IC HS- Awards $25.0
Approprations (Billions)
6,000
NIH Appropriations (billions)
$20.0
5,000
Number of Awards
4,000 $15.0
3,000
$10.0
2,000
$5.0
1,000
- $-
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
Dollars Awarded for Competing and non-Competing Research Grants with and without
Human Subjects by Locus of review Compared to NIH Appropriations (Fiscal Years 1996
to 2005)
$8.00 30.000
CSR HS+
CSR HS-
$7.00
I/C Review HS+
25.000
I/C Review HS-
$6.00 NIH Appropriations
NIH Appropriations (Billions)
Dollars Awarded (Billions)
20.000
$5.00
$4.00 15.000
$3.00
10.000
$2.00
5.000
$1.00
$- -
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
Research Project Grants (FY 2005)
RPG Applications
RPG
43,268 Applications
16,603 HS+ (38%)
26,665 HS- (62%)
Locus of Review
CSR IC
35,208 Applications 8,060 Applications
11.955 HS+ (34%) 4,648 HS+ (58%)
23,253 HS- (66%) 3,412 HS- (42%)
Awards
HS+ HS- HS+ HS-
2,177 Awards 5,530 Awards 1,041 Awards 900 Awards
Success Rate 18% Success Rate 24% Success Rate 22% Success Rate 26%
Human Subjects Research Project Grant Applications Reviewed in CSR and ICs with
Success Rates
14,000 50%
CSR HS+ Applications
CSR HS+ Awards
IC HS+ Applications
12,000
IC HS+ Awards
CSR HS+ Success Rate 40%
IC HS+ Success Rate
10,000
30%
Success Rate
8,000
Number
6,000
20%
4,000
10%
2,000
- 0%
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
Number of Research Project Grant Awards involving or not involving Human Subjects by
Locus of Review Compared to NIH Appropriations
6,000 $30.0
CSR HS+ Awards
CSR HS- Awards
IC HS+ Awards
5,000 IC HS- Awards $25.0
Approprations (Billions)
NIH Appropriations (billions)
4,000 $20.0
Number of Awards
3,000 $15.0
2,000 $10.0
1,000 $5.0
- $-
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
Dollars Awarded for Competing and non-Competing Research Project Grants with and
without Human Subjects by Locus of Review Compared to NIH Appropriations
(Fiscal Years 1996 to 2005)
$8.00 30.000
$7.00 CSR HS+
CSR HS- 25.000
I/C Review HS+
$6.00
I/C Review HS-
NIH Appropriations (Billions)
Dollars Awarded (Billions)
NIH Appropriations 20.000
$5.00
$4.00 15.000
$3.00
10.000
$2.00
5.000
$1.00
$- -
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
R01 and Equivalent Grants (FY 2005)
R01 Equivalent Applications
R01 Equiv.
28,423 Applications
10,199 HS+ (36%)
18,224 HS- (64%)
Locus of Review
CSR IC
26,243 Applications 2,180 Applications
8,687 HS+ (33%) 1,512 HS+ (69%)
17,556 HS- (67%) 668 HS- (31%)
Awards
HS+ HS- HS+ HS-
1,627 Awards 4,298 Awards 298 Awards 240 Awards
Success Rate 19% Success Rate 24% Success Rate 20% Success Rate 36%
Human Subjects R01 Equivalent Applications Reviewed in CSR and ICs with Success
Rates
10,000 CSR HS+ Applications 50%
CSR HS+ Awards
9,000 IC HS+ Applications
IC HS+ Awards
8,000 CSR HS+ Success Rate 40%
IC HS+ Success Rate
7,000
6,000 30%
Success Rate
Number
5,000
4,000 20%
3,000
2,000 10%
1,000
- 0%
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
R01 Equivalent Awards involving or not involving Human Subjects by Locus of Review
Compared to NIH Appropriations
6,000 $30.0
CSR HS+ Awards
CSR HS- Awards
IC HS+ Awards
5,000 IC HS- Awards $25.0
Approprations (Billions)
NIH Appropriations (billions)
4,000 $20.0
Number of Awards
3,000 $15.0
2,000 $10.0
1,000 $5.0
- $-
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
Dollars Awarded for Competing and non-Competing R01 Equivalent Grants with and
without Human Subjects by Locus of review Compared to NIH Appropriations
(Fiscal Years 1996 to 2005)
$7.00 30.000
CSR HS+
CSR HS-
$6.00 I/C Review HS+
25.000
I/C Review HS-
NIH Appropriations
NIH Appropriations (Billions0
$5.00
Dollars Awarded (Billions)
20.000
$4.00
15.000
$3.00
10.000
$2.00
5.000
$1.00
$- -
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
Center Grants (FY 2005)
Center Applications
Center
818 Applications
481 HS+ (59%)
337 HS- (41%)
Locus of Review
CSR IC
39 Applications 779 Applications
14 HS+ (36%) 467 HS+ (60%)
25 HS- (64%) 312 HS- (40%)
Awards
HS+ HS- HS+ HS-
10 Awards 18 Awards 153 Awards 121 Awards
Success Rate 71% Success Rate 72% Success Rate 35% Success Rate 39%
Human Subjects Research Center Grant Applications Reviewed in CSR and ICs with
Success Rates
700 100%
CSR HS+ Applications
CSR HS+ Awards
90%
IC HS+ Applications
600
IC HS+ Awards
CSR HS+ Success Rate 80%
IC HS+ Success Rate
500
70%
60%
Success Rate
400
Number
50%
300
40%
30%
200
20%
100
10%
- 0%
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
Number of Center Grant Awards involving or not involving Human Subjects by Locus of
Review Compared to NIH Appropriations
250 $30.0
CSR HS+ Awards
CSR HS- Awards
IC HS+ Awards
IC HS- Awards $25.0
200 Approprations (Billions)
NIH Appropriations (billions)
$20.0
Number of Awards
150
$15.0
100
$10.0
50
$5.0
- $-
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
Dollars Awarded for Competing and non-Competing Center Grants with and without
Human Subjects by Locus of Review Compared to NIH Appropriations
(Fiscal Year 1996 to 2005)
$2.00 30.000
CSR HS+
$1.80 CSR HS-
I/C Review HS+
25.000
$1.60 I/C Review HS-
NIH Appropriations
NIH Appropriations (Billions)
$1.40
Dollars Awarded (Billions)
20.000
$1.20
$1.00 15.000
$0.80
10.000
$0.60
$0.40
5.000
$0.20
$- -
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
Part III
Conclusions
• Hypothesis
– Clinical research grant applications have
lower success rates* than basic research
applications.
• True for RGs, RPGs, R01s, and Centers
– Success rate correlates with locus of review
• True for RGs, RPGs, R01s, and Centers
But the devil is in the details…
Conclusions
Success Number of Dollars
rate awards awarded
RGs CSR CSR CSR
IC IC IC
RPGs CSR CSR CSR
IC IC IC
R01 CSR CSR CSR
equivalents IC IC IC
Centers CSR CSR CSR
IC IC IC
Key questions
Why?
What interventions
work?