NIH Future Directions Craig J. McClain, M.D., Professor Division of Gastroenterology/Hepatology Departments of Medicine, P...
Objectives <ul><li>NIH Finances </li></ul><ul><li>NIH trends, changes </li></ul><ul><li>Update on CTSAs </li></ul><ul><li>...
NIH Budget: What Is Really Happening? Universities Flat-line budget Major NIH funding loss
“ What we have here is a failure to communicate” Cool Hand Luke
Politics & Economics: Law Shifts NIH Balance of Power  Patient Groups Fear For Their Research As Funds Are Pooled By Berna...
 
NIH Congressional Appropriations 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 0 5 10 15 20 25 30 35 NIH ($billions) $...
 
As Many New  Applicants  in the  Last 2 years  as during the previous 5 years! <ul><li>  ≈   </li></ul>26583 - 21249 (2003...
UofL/UK NIH Funding Source: NIH OER database
UofL Programs of Distinction
Growth of R21 Applications  Reviewed at CSR vs. Other ICs 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 2001 200...
Growth of R01 Applications  Reviewed at CSR vs. Other ICs 0 5,000 10,000 15,000 20,000 25,000 30,000 35,000 2001 2002 2003...
Number of NIH  K  Awards GOOD NEWS 1,500 2,000 2,500 3,000 3,500 4,000 4,500 1994 1995 1996 1997 1998 1999 2000 2001 2002 ...
NIH Goal <ul><li>Fund training awards </li></ul><ul><li>Keep the pipeline open </li></ul>
TEST – What is “correct” first grant? <ul><li>36 year old new MD faculty member </li></ul><ul><ul><li>RO3 </li></ul></ul><...
NIH Trends/Innovations
Major Complaints About NIH Peer Review <ul><li>The process is too slow </li></ul><ul><li>There are not enough senior/exper...
Updated Oct. 4, 2006 Electronic Submission Transition Timeline
Electronic Submission <ul><li>New dates prevent “submission overload” </li></ul><ul><li>Most submissions not on 1 st  of m...
Shorter Application <ul><li>Probably ~15 pages </li></ul><ul><li>Many other grants shorter </li></ul><ul><ul><li>Canada, V...
Reviewer Crisis  <ul><li>Far too many reviewers on study sections </li></ul><ul><li>Too many ad hoc reviewers </li></ul><u...
The First NIH Study Section  1946 The Last NIH Study Section  2006 Smaller Larger Older Younger Reviewed ~12 grants Review...
Expanding Peer Review’s Platforms <ul><li>Electronic Reviews </li></ul><ul><li>Telephone Enhanced Discussions </li></ul><u...
What It Looks Like: Video Enhanced Discussions
What It Looks Like:  Asynchronous  Electronic Discussions
Shortened Review Cycle <ul><li>NIH Pilot Study of New Investigator R01s </li></ul><ul><li>Who Benefits from Quick Review? ...
A Proposal for Deep Innovation Grants <ul><li>Short, 5-8 pages </li></ul><ul><li>Focus on people, not payoff </li></ul><ul...
We’re not good predicting big advances
Multiple PI Initiative <ul><li>Principal Investigators (PIs) sometimes work in teams </li></ul><ul><li>Many projects depen...
Fiscal Year Age - Average MD age > 44 Average age of New Investigators at  initial R01/R29 award 43.3 36.7 38.3 39.6 42.7 ...
NIH Peer Review of Grant Applications for Clinical Research Kotchen, et al. JAMA 2004;291:836 <ul><li>Conclusion: </li></u...
Automated Referral Workflow System - How does my grant get to the right place? 14 Remainder referred by human experts 39 M...
Travel - savings <ul><li>Purchase non-refundable (restricted) coach tickets instead of unrestricted tickets </li></ul>$4,7...
Update on CTSAs
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
P20 application
Need better COBRE planning
Update on UofL CTSA, LICTS, and UofL Research Challenges
University of Louisville ’ s  CTSA President ’ s Office President Provost Executive VP for Research  Director, LICTS Inter...
<ul><li>Top priority of many institutions </li></ul><ul><li>UofL needs to evaluate goals </li></ul>
CTSA/LICTS Challenges and Goals Top 10 List <ul><li>1.  University CTSA Goals—Need Summit </li></ul><ul><li>2. Institute S...
University of Louisville Research Goals/Issues Top 10 List <ul><li>1.  University Mission/Goals/Long Range Plan </li></ul>...
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NIH Future Directions

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  • BRDPI FY04 (actual) 3.5% FY05 (est.) 3.3% FY06 (est.) 3.2% FY07 (est.) 3.2%
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  • NIH Future Directions

    1. 1. 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
    2. 2. Objectives <ul><li>NIH Finances </li></ul><ul><li>NIH trends, changes </li></ul><ul><li>Update on CTSAs </li></ul><ul><li>Challenges for UofL CTSA, LICTS and U of L Research </li></ul>
    3. 3. NIH Budget: What Is Really Happening? Universities Flat-line budget Major NIH funding loss
    4. 4. “ What we have here is a failure to communicate” Cool Hand Luke
    5. 5. 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 &quot;common fund&quot; designed eventually to pool about 5% of the NIH's money. That is $1.5 billion a year at today's levels. The idea is to pour funding into research projects that cut across traditional biomedical fields and across multiple NIH fiefs. The new program addresses some of Congress's concerns that the NIH is big, slow and can't innovate.
    6. 7. NIH Congressional Appropriations 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 0 5 10 15 20 25 30 35 NIH ($billions) $ (Billions) Doubling 0 10 20 30 40 50 60 70 80 UofL ($millions) $ (Millions)
    7. 9. As Many New Applicants in the Last 2 years as during the previous 5 years! <ul><li> ≈ </li></ul>26583 - 21249 (2003) – (1999) Period of doubling 5334 31791 - 26583 (2005) – (2003) 5208
    8. 10. UofL/UK NIH Funding Source: NIH OER database
    9. 11. UofL Programs of Distinction
    10. 12. Growth of R21 Applications Reviewed at CSR vs. Other ICs 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 2001 2002 2003 2004 2005 2006 CSR Other
    11. 13. Growth of R01 Applications Reviewed at CSR vs. Other ICs 0 5,000 10,000 15,000 20,000 25,000 30,000 35,000 2001 2002 2003 2004 2005 2006 CSR Other
    12. 14. Number of NIH K Awards GOOD NEWS 1,500 2,000 2,500 3,000 3,500 4,000 4,500 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 Fiscal Year Number
    13. 15. NIH Goal <ul><li>Fund training awards </li></ul><ul><li>Keep the pipeline open </li></ul>
    14. 16. TEST – What is “correct” first grant? <ul><li>36 year old new MD faculty member </li></ul><ul><ul><li>RO3 </li></ul></ul><ul><ul><li>R21 </li></ul></ul><ul><ul><li>RO1 </li></ul></ul><ul><ul><li>K23 </li></ul></ul><ul><ul><li>K12 </li></ul></ul>
    15. 17. NIH Trends/Innovations
    16. 18. Major Complaints About NIH Peer Review <ul><li>The process is too slow </li></ul><ul><li>There are not enough senior/experienced reviewers </li></ul><ul><li>The process favors predictable research instead of significant, innovative, or transformative research </li></ul><ul><li>Clinical research may not fare as well as other research </li></ul><ul><li>The time and effort required to write, submit, resubmit, review and re-review is a heavy burden on applicants and reviewers </li></ul>
    17. 19. Updated Oct. 4, 2006 Electronic Submission Transition Timeline
    18. 20. Electronic Submission <ul><li>New dates prevent “submission overload” </li></ul><ul><li>Most submissions not on 1 st of month </li></ul><ul><li>NIH contributes only about ½ of submissions </li></ul><ul><li>Feb 5, 2007 – about 4,000 RO1s </li></ul><ul><li>82% error-free on 1 st attempt </li></ul><ul><li>eRA Commons record 19,283 logins on Feb 5, 2007 </li></ul>
    19. 21. Shorter Application <ul><li>Probably ~15 pages </li></ul><ul><li>Many other grants shorter </li></ul><ul><ul><li>Canada, VA, DOD </li></ul></ul>NIH Guide Survey on Shorter R01 Applications 3,203 846 2,357 Number Percent Responses 26% Against Shorter Applications 100% Total 74% For Shorter Applications
    20. 22. Reviewer Crisis <ul><li>Far too many reviewers on study sections </li></ul><ul><li>Too many ad hoc reviewers </li></ul><ul><li>Not enough “senior” reviewers </li></ul><ul><li>Almost 80,000 grants – lots of work! </li></ul><ul><li>~ 20,000 reviewers </li></ul>
    21. 23. The First NIH Study Section 1946 The Last NIH Study Section 2006 Smaller Larger Older Younger Reviewed ~12 grants Review ~ 6 grants
    22. 24. Expanding Peer Review’s Platforms <ul><li>Electronic Reviews </li></ul><ul><li>Telephone Enhanced Discussions </li></ul><ul><li>Video Enhanced Discussions </li></ul><ul><li>Asynchronous Electronic Discussions </li></ul>Study Sections Our Goal: 10% of all reviews to be electronic in 2007
    23. 25. What It Looks Like: Video Enhanced Discussions
    24. 26. What It Looks Like: Asynchronous Electronic Discussions
    25. 27. Shortened Review Cycle <ul><li>NIH Pilot Study of New Investigator R01s </li></ul><ul><li>Who Benefits from Quick Review? </li></ul><ul><li>- On “bubble” or close </li></ul><ul><li>- Able to respond quickly with changes/new data </li></ul><ul><li>Only 13% in pilot study could do so </li></ul>
    26. 28. A Proposal for Deep Innovation Grants <ul><li>Short, 5-8 pages </li></ul><ul><li>Focus on people, not payoff </li></ul><ul><li>Relevance separated from review </li></ul><ul><li>Ranking, not scoring </li></ul>
    27. 29. We’re not good predicting big advances
    28. 30. Multiple PI Initiative <ul><li>Principal Investigators (PIs) sometimes work in teams </li></ul><ul><li>Many projects dependent on collaboration </li></ul><ul><li>Growing consensus that team science is discouraged by recognition of only one PI. </li></ul><ul><li>Other Federal agencies have recognized co-PIs for years </li></ul><ul><li>To avoid confusion, the term “Co-PI” will not be used by NIH </li></ul><ul><li>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 . </li></ul>
    29. 31. Fiscal Year Age - Average MD age > 44 Average age of New Investigators at initial R01/R29 award 43.3 36.7 38.3 39.6 42.7 43.2 39.3 39.1 39.3 42.8 41.7 34.3 36.8 38.9 41.6 34 36 38 40 42 44 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 MD MD-PhD PhD Linear (PhD) Linear (MD)
    30. 32. NIH Peer Review of Grant Applications for Clinical Research Kotchen, et al. JAMA 2004;291:836 <ul><li>Conclusion: </li></ul><ul><ul><li>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. </li></ul></ul>
    31. 33. Automated Referral Workflow System - How does my grant get to the right place? 14 Remainder referred by human experts 39 Machine learning prediction when no PI request and > 80% likelihood of agreement with human experts 47 PI assignment request automatically mined from cover letter Percentage Referral Method
    32. 34. Travel - savings <ul><li>Purchase non-refundable (restricted) coach tickets instead of unrestricted tickets </li></ul>$4,742,251 YTD Fare Savings $175,321 cost of changes + fees   658 Changes requested  9,134 # of tickets issued   Preliminary Pilot Data – June to November 2006
    33. 35. Update on CTSAs
    34. 53. P20 application
    35. 54. Need better COBRE planning
    36. 55. Update on UofL CTSA, LICTS, and UofL Research Challenges
    37. 56. University of Louisville ’ s CTSA President ’ s Office President Provost Executive VP for Research Director, LICTS Internal Advisory Committee - Deans - Hospitals - Others LICTS Executive Committee - Community - Education - Biostatistics/Bioinformatics - Methologies /Resources - Pilots - Regulatory/Ethics Director, Education Community Biostatistics/ Bioinformatics Partners in Innovation Pilots Education Outreach AHEC Trover Clinic Health Depts. Biostat . Consulting Bioinformatics E - record Drug development Devices Studies Interdisciplinary MS/PhD Training grants Curriculum Dev. External Advisory Committee Regulatory Hospitals Facilities/Cores Ethics Executive VP for Health Affairs
    38. 57. <ul><li>Top priority of many institutions </li></ul><ul><li>UofL needs to evaluate goals </li></ul>
    39. 58. CTSA/LICTS Challenges and Goals Top 10 List <ul><li>1. University CTSA Goals—Need Summit </li></ul><ul><li>2. Institute Status </li></ul><ul><li>3. Director Position </li></ul><ul><li>4. Space Issues—Short and Long Term </li></ul><ul><li>5. Education—Degree Granting </li></ul><ul><li>6. U of L Internal support for Education Initiatives </li></ul><ul><li>7. Be prepared to submit institutional grants, such as K12, K30, T32s, etc., and individual K, T, F grants </li></ul><ul><li>8. Research Partners (e.g., Humana, Jewish, Norton, Metacyte) </li></ul><ul><li>9. Biostatistics/Bioinformatics support </li></ul><ul><li>10. Budget/Financial Support </li></ul>Dave’s Top 10 Craig’s Top 10
    40. 59. University of Louisville Research Goals/Issues Top 10 List <ul><li>1. University Mission/Goals/Long Range Plan </li></ul><ul><li>2. Bridge Funding </li></ul><ul><li>3. Start-up Funds </li></ul><ul><li>4. Limited Hospital Support </li></ul><ul><li>5. “Flat Line” NIH Budget </li></ul><ul><li>● Understand NIH Roadmap </li></ul><ul><li>● Understand Changes at NIH </li></ul><ul><li>6. Clinical Trials Issues </li></ul><ul><li>● Identify it as a problem that needs to be fixed </li></ul><ul><li>Contracting, Western IRB, Facility support—e.g., CRC, </li></ul><ul><li>Malpractice </li></ul><ul><li>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) </li></ul><ul><li>More HSC interactions with Belknap (Engineering, Business, Social Work, A&S, Graduate School,Education/Human Development) </li></ul><ul><li>9. Better Use of Existing U of L Research Resources (decreased duplication, better core use/support, space plan) </li></ul><ul><li>10. Accessibility and Expansion of Biostatistics/Bioinformatics </li></ul>Dave’s Top 10 Craig’s Top 10

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