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NIH Future Directions. Craig J. McClain, M.D., Professor Division of Gastroenterology/Hepatology Departments of Medicine, Pharmacology and Toxicology University of Louisville Louisville VA Medical Center . Objectives. NIH Finances NIH trends, changes Update on CTSAs

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nih future directions

NIH Future Directions

Craig J. McClain, M.D., Professor

Division of Gastroenterology/Hepatology

Departments of Medicine, Pharmacology and Toxicology

University of Louisville

Louisville VA Medical Center

objectives
Objectives
  • NIH Finances
  • NIH trends, changes
  • Update on CTSAs
  • Challenges for UofL CTSA, LICTS and U of L Research
nih budget what is really happening
NIH Budget: What Is Really Happening?

Universities

Flat-line budget

Major NIH funding loss

slide4

Cool Hand Luke

“What we have here is a failure to communicate”

slide5

Politics & Economics: Law Shifts NIH Balance of Power

Patient Groups Fear For Their Research As Funds Are Pooled

By Bernard Wysocki Jr., The Wall Street Journal, Jan 31, 2007

Congress has strengthened Dr. [Elias Zerhouni]'s hand considerably. As part of a bill passed in December's lame-duck session, Dr. Zerhouni and his successors will be able to organize a "common fund" designed eventually to pool about 5% of the NIH's money. That is $1.5 billion a year at today's levels. The idea is to pour funding into research projects that cut across traditional biomedical fields and across multiple NIH fiefs. The new program addresses some of Congress's concerns that the NIH is big, slow and can't innovate.

nih congressional appropriations

80

70

UofL ($millions)

60

50

$ (Millions)

40

30

20

10

0

NIH Congressional Appropriations

35

30

NIH ($billions)

25

20

$ (Billions)

15

10

5

0

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

Doubling

as many new applicants in the last 2 years as during the previous 5 years
As Many New Applicants in the Last 2 years as during the previous 5 years!

5334

5208

26583 - 21249

31791 - 26583

(2003) – (1999)

(2005) – (2003)

Period of doubling

uofl uk nih funding
UofL/UK NIH Funding

Source: NIH OER database

slide12

Growth of R21 Applications Reviewed at CSR vs. Other ICs

9,000

8,000

7,000

6,000

5,000

4,000

3,000

2,000

1,000

0

2001

2002

2003

2004

2005

2006

CSR

Other

slide13

Growth of R01 Applications Reviewed at CSR vs. Other ICs

35,000

30,000

25,000

20,000

15,000

10,000

5,000

0

2001

2002

2003

2004

2005

2006

CSR

Other

number of nih k awards
Number of NIH K Awards

GOOD NEWS

4,500

4,000

3,500

Number

3,000

2,500

2,000

1,500

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

Fiscal Year

nih goal
NIH Goal
  • Fund training awards
  • Keep the pipeline open
test what is correct first grant
TEST – What is “correct” first grant?
  • 36 year old new MD faculty member
    • RO3
    • R21
    • RO1
    • K23
    • K12
major complaints about nih peer review
Major Complaints About NIH Peer Review
  • The process is too slow
  • There are not enough senior/experienced reviewers
  • The process favors predictable research instead of significant, innovative, or transformative research
  • Clinical research may not fare as well as other research
  • The time and effort required to write, submit, resubmit, review and re-review is a heavy burden on applicants and reviewers
electronic submission
Electronic Submission
  • New dates prevent “submission overload”
  • Most submissions not on 1st of month
  • NIH contributes only about ½ of submissions
  • Feb 5, 2007 – about 4,000 RO1s
  • 82% error-free on 1st attempt
  • eRA Commons record 19,283 logins on Feb 5, 2007
shorter application
Shorter Application
  • Probably ~15 pages
  • Many other grants shorter
    • Canada, VA, DOD

NIH Guide Survey on Shorter R01 Applications

reviewer crisis
Reviewer Crisis
  • Far too many reviewers on study sections
  • Too many ad hoc reviewers
  • Not enough “senior” reviewers
  • Almost 80,000 grants – lots of work!
  • ~ 20,000 reviewers
the first nih study section 1946
The First NIH Study Section 1946

The Last NIH Study Section 2006

Smaller Larger

Older Younger

Reviewed ~12 grants Review ~ 6 grants

expanding peer review s platforms
Expanding Peer Review’s Platforms

Study Sections

Electronic Reviews

  • Telephone Enhanced Discussions
  • Video Enhanced Discussions
  • Asynchronous Electronic Discussions

Our Goal: 10% of all reviews to be electronic in 2007

shortened review cycle
Shortened Review Cycle
  • NIH Pilot Study of New Investigator R01s
  • Who Benefits from Quick Review?

- On “bubble” or close

- Able to respond quickly with changes/new data

  • Only 13% in pilot study could do so
a proposal for deep innovation grants
A Proposal for Deep Innovation Grants
  • Short, 5-8 pages
  • Focus on people, not payoff
  • Relevance separated from review
  • Ranking, not scoring
multiple pi initiative
Multiple PI Initiative
  • Principal Investigators (PIs) sometimes work in teams
  • Many projects dependent on collaboration
  • Growing consensus that team science is discouraged by recognition of only one PI.
  • Other Federal agencies have recognized co-PIs for years
  • To avoid confusion, the term “Co-PI” will not be used by NIH
  • The application is the same as it would be for a single PI, with the exception of an expanded list of PIs and a Leadership Plan.
slide31

Average age of New Investigators at

initial R01/R29 award

44

- Average MD age > 44

43.3

42.8

43.2

42.7

42

41.7

41.6

39.6

40

39.3

39.3

39.1

Age

38.9

MD

38.3

38

MD-PhD

PhD

36.8

36.7

Linear (PhD)

36

Linear (MD)

34.3

34

1981

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1999

2000

2001

2002

2003

2004

1995

1970

1971

1972

1973

1974

1975

1976

1977

1978

1979

1980

1996

1997

1998

Fiscal Year

nih peer review of grant applications for clinical research kotchen et al jama 2004 291 836
NIH Peer Review of Grant Applicationsfor Clinical ResearchKotchen, et al. JAMA 2004;291:836
  • Conclusion:
    • Although physicians compete favorably in the peer review process, review outcomes are modestly less favorable for grant applications for clinical research than for laboratory research.
slide33

Automated Referral Workflow System

- How does my grant get to the right place?

travel savings
Travel - savings

Purchase non-refundable (restricted) coach tickets instead of unrestricted tickets

slide56

University of Louisville

s

CTSA

President

s Office

President

Executive VP for Research

Executive VP for Health Affairs

Provost

Internal Advisory Committee

-

Deans

Director, LICTS

External Advisory Committee

-

Hospitals

-

Others

LICTS Executive Committee

-

Community

-

Education

-

Biostatistics/Bioinformatics

-

Methologies

/Resources

Director, Education

-

Pilots

-

Regulatory/Ethics

Partners in

Biostatistics/

Community

Facilities/Cores

Regulatory

Hospitals

Ethics

Education

Pilots

Innovation

Bioinformatics

Outreach

Interdisciplinary MS/PhD

Studies

Biostat

. Consulting

Drug development

AHEC

Training grants

Bioinformatics

Devices

Trover

Clinic

Curriculum Dev.

E

-

record

Health Depts.

slide57
Top priority of many institutions
  • UofL needs to evaluate goals
ctsa licts challenges and goals top 10 list
CTSA/LICTS Challenges and GoalsTop 10 List

1. University CTSA Goals—Need Summit

2. Institute Status

3. Director Position

4. Space Issues—Short and Long Term

5. Education—Degree Granting

6. U of L Internal support for Education Initiatives

7. Be prepared to submit institutional grants, such as K12, K30, T32s, etc., and individual K, T, F grants

8. Research Partners (e.g., Humana, Jewish, Norton, Metacyte)

9. Biostatistics/Bioinformatics support

10. Budget/Financial Support

Dave’s Top 10

Craig’s Top 10

university of louisville research goals issues top 10 list
University of Louisville Research Goals/IssuesTop 10 List

1. University Mission/Goals/Long Range Plan

2. Bridge Funding

3. Start-up Funds

4. Limited Hospital Support

5. “Flat Line” NIH Budget

● Understand NIH Roadmap

● Understand Changes at NIH

6. Clinical Trials Issues

● Identify it as a problem that needs to be fixed

Contracting, Western IRB, Facility support—e.g., CRC,

Malpractice

7. Building Partnerships in Research (e.g., Humana) and including our local community partners (e.g., Norton, Jewish, Kindred, West End, Louisville Metro Health Dept., etc.) and regional partners (e.g., AHEC)

  • More HSC interactions with Belknap (Engineering, Business, Social Work, A&S, Graduate School,Education/Human Development)

9. Better Use of Existing U of L Research Resources (decreased duplication, better core use/support, space plan)

10. Accessibility and Expansion of Biostatistics/Bioinformatics

Dave’s Top 10

Craig’s Top 10