NIH Future Directions

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. Objectives • NIH Finances • NIH trends, changes • Update on CTSAs • Challenges for UofL CTSA, LICTS and U of L Research

3. NIH Budget: What Is Really Happening? Universities Flat-line budget Major NIH funding loss

4. Cool Hand Luke “What we have here is a failure to communicate”

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 "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.

7. 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

9. ≈ 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

10. UofL/UK NIH Funding Source: NIH OER database

11. UofL Programs of Distinction

12. 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

13. 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

14. 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

15. NIH Goal • Fund training awards • Keep the pipeline open

16. TEST – What is “correct” first grant? • 36 year old new MD faculty member • RO3 • R21 • RO1 • K23 • K12

17. NIH Trends/Innovations

18. 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

19. Electronic SubmissionTransition Timeline Updated Oct. 4, 2006

20. 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

21. Shorter Application • Probably ~15 pages • Many other grants shorter • Canada, VA, DOD NIH Guide Survey on Shorter R01 Applications

22. 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

23. The First NIH Study Section 1946 The Last NIH Study Section 2006 Smaller Larger Older Younger Reviewed ~12 grants Review ~ 6 grants

24. 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

25. What It Looks Like: Video Enhanced Discussions

26. What It Looks Like: Asynchronous Electronic Discussions

27. 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

28. A Proposal for Deep Innovation Grants • Short, 5-8 pages • Focus on people, not payoff • Relevance separated from review • Ranking, not scoring

29. We’re not good predicting big advances

30. 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.

31. 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

32. 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.

33. Automated Referral Workflow System - How does my grant get to the right place?

34. Travel - savings Purchase non-refundable (restricted) coach tickets instead of unrestricted tickets

35. Update on CTSAs