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2 Biomedical Research in the U.S.A. The Strategic National Importance of NIH Peer Review C.N.R., Roma, March 2007 National Institutes of Health U.S. Department of Health and Human Services

3 The Strategic National Importance of Peer Review

4 Why Has U.S. Research Been So Successful? Evolution of unique dynamic partnerships -- through NIH -- between Government and academic/medical schools 100% of NIH funds to universities and medical centers awarded through peer review (Only 4-10% in Europe)

5 The Overarching Influence of NIH Peer Review in the USA For U.S. Universities and Academic Medical Centers The Promotion Committee of Medical Schools The Prestige and Finances of Universities and Medical Schools For People and for Public Health Which research is done Which cures people get Which lifestyle people follow Which biotechnology is developed

6 How Federal Support of Biomedical Research Developed in the U.S.A.

7 How Federal Support of Biomedical Research Developed in the U.S.A. Background: The past and present reluctance of the U.S. Federal Government to fund directly universities and research How did we get there? Mobilization of scientists and resources by the military during crises wars, epidemics. Maintaining the momentum created in crises.

8 Responses to Yellow Fever 1879 Yellow fever in Mississippi Valley: a $30,000 grant to universities : the 1 st peer review for research.

9 The Fundamental Tenets for N.I.H. 1. The only possible source for adequate support of our medical research is the taxing power of the Federal Government Federal government and the politicians must assure complete freedom for the individual scientists in developing and conducting their research work. 3. Reviews should be conducted by outside experts essentially without compensation. 4. Program management and review functions should be separated.

10 The National Institutes of Health

11 Department of Health and Human Services Total = $592 Billion Total = $52.6 Billion HRSA 11% CDC 8% Medicare 58% Discretionary Programs 9% NIH 54% ` FDA 3% Medicaid 33% Other 24 % HHS, Budget in Brief FY 2006.

12 NIH Budget in FY 2006 is $28.6 Billion Spending at NIH $4.8 B Spending Outside NIH $23.8 B

13 Balanced National Biomedical Research Portfolio Clinical Research Clinical Research Translational Research Basic Research Translational Research Basic Research NIH - $28B Private Sector - $59B

14 Growth in NIH Grant Awards to Italian Institutions Number of Italian Applications Submitted Funds and Grants Awarded Funds Awarded per Fiscal Year Number of Applications Fiscal Year Fiscal Year Amount of Grants In Million $4 $3 $2 $1 $ Fiscal Year $ #of grants Number of Grants

15 NIH Transforming medicine through discovery

16 Challenge of Rising U.S. Health Costs Biomedical Research Must Deliver Percent of U.S. GDP 20% 18% 16% 14% 12% 10% National Health Expenditures as a Percent of GDP Actual Projected $4.1 trillion 8%

17 Land of the Free Home of the Fries The Economist, Dec 13-19, 2003

18 Need to Transform Medical Research in the 21st Century 20 th Century 21 st Century Treat disease when symptoms appear Intervene before disease or symptoms appear Understand the causes of disease at the organ level Understand molecular events and detect patients at risk Pay high health care and disability costs. Reduce health care and disability costs.

19 NIH s Vision for the Future Predictive Personalized Preemptive

20 NIH Peer Review

21 2006: NIH Peer Review Statistics 80,000 applications received and reviewed a year 25,000 reviewers a year 480 Scientific Review Administrators 2,300 review meetings a year

22 24 NIH Institutes and Centers Fund Grants NINDS NIAID NIDCR NINR NCI NIEHS NIDCD NLM NCCAM NIGMS NCRR Center for Scientific Review FIC NIBIB NIDA NIDDK NCMHD NIA NIAAA NEI NIAMS NIMH NHLBI NHGRI NICHD

23 Center for Scientific Review

24 CSR Mission Statement To see that NIH grant applications receive fair, independent, expert, and timely reviews -- free from inappropriate influences -- so NIH can fund the most promising research.

25 CSR 4 Review Divisions & 23 IRGs Division of Biologic Basis of Disease Elliot Postow, Ph.D. Division of Molecular & Cellular Mechanisms Donald Schneider, Ph.D. Division of Physiology and Pathology Michael Martin, Ph.D. Division of Clinical and Population-Based Studies Anita Miller Sostek, Ph.D AIDS and Related Research IRG (AARR) Ranga V. Srinivas, Ph.D. Endocrinology, Metabolism, Nutrition, and Reproductive Sciences (EMNR) Sooja Kim, Ph.D. Immunological Sciences IRG (IMM) Calbert Laing, Ph.D. Infectious Diseases and Microbiology IRG (IDM) Alex Politis, Ph.D. Oncological Sciences IRG (ONC) Syed Quadri, Ph.D. Bioengineering Sciences and Technologies IRG (BST) Sally Amero, Ph.D. Biology of Development and and Aging (BDA) Sherry Dupere, Ph.D. Biological Chemistry and Macromolecular Biophysics IRG (BCMB) John Bowers, Ph.D. Cell Biology IRG (CB) Marcia Steinberg, Ph.D. Genes, Genomes, and Genetics IRG (GGG) Richard Panniers, Ph.D. Molecular, Cellular and Developmental Neuroscience IRG (MDCN) Carole Jelsema, Ph.D. Cardiovascular Sciences IRG (CVS) Joyce Gibson, D.Sc. Digestive Sciences IRG (DIG) Mushtaq Khan, Ph.D., DVM Hematology IRG (HEME) Joyce Gibson, D.Sc. Integrative, Functional and Cognitive Neuroscience IRG (IFCN) Christine Melchior, Ph.D. Musculoskeletal, Oral, and Skin Sciences IRG (MOSS) Daniel McDonald, Ph.D. Renal and Urological Sciences IRG (RUS) Daniel McDonald, Ph.D. Respiratory Sciences IRG (RES) Mushtaq Khan, Ph.D., DVM Behavioral & Biobehavioral Processes IRG (BBBP) Karen Sirocco, Ph.D. Brain Disorders and Clinical Neuroscience IRG (BDCN) Dana Plude, Ph.D. Health of the Population IRG (HOP) Robert Weller, Ph.D. Risk, Prevention, and Health Behavior IRG (RPHB) Michael Micklin, Ph.D. Surgery, Radiology, and Bioengineering IRG (SRB) Eileen Bradley, D.Sc.

26 Summary Statement and Priority Score transmitted to applicant and Institute NIH Peer Review Researcher writes and submits application Application assigned to NIH Institutes & Study Sections 3 Reviewers read and write critiques Application assigned to reviewers

27 Dual Review System for Grant Applications First Level of Review Scientific Review Group (SRG) Second Level of Review NIH Institute/Center Council

28 What the Community is Saying The current NIH grant evaluation system... often resembles the evaluation process in American Idol. Michele Pagano, NYU School of Med. H. Mandel, GWU E. Vesell, Penn State The judging of grants has become a charade. Zena Werb, President, American Society for Cell Biology

29 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 The time and effort required to write and review are a heavy burden on applicants and reviewers

30 The First NIH Study Section 1946 The Last NIH Study Section 2007

31 Applications and Process of Grant Applications 90% of the applications are investigator, curiosity driven research Approximately 60% on basic science research 25% from new/young investigators 27% from women applicants 95% from the U.S.A. 3 Deadlines/year Success Rate 30-10% Time from application to funding: 9 months

32 Reengineering Peer Review

33 Complexity and Impact CSR Operations Current Systems New System? Time

34 Changes in CSR Operations 1. Increase Communication and Transparency 2. Increase Effectiveness of the Process 3. Increase Efficiency

35 Increase Communication and Transparency

36 Increase Effectiveness of the Process CSR: February July 1, , 2007

37 This is Not a FIAT Assembly Line Receipt Refer Evaluate Scientific Merit of Applications EnterpriseArchitecture@mail.nih.gov

38 Increase Efficiency How we distribute 80,000 applications? Retooled for electronic submission Applications are now submitted electronically Assign applications using text fingerprinting, artificial intelligence software Full Implementation by June 2007

39 A Vision for Peer Review 1. Shorten the review cycle 2. Do more to recruit and retain more high-quality reviewers and decrease the burden on applicants and reviewers 3. Improve the identification of significant, innovative and high-impact research

40 A Vision for Peer Review 1. Shorten the review cycle

41 Shortening the Review Cycle Goal: To provide applicants a review and score within 3 months so they could reapply with a revised application 4 months earlier 3 reviews within one year

42 Shortening the NIH Review Cycle, First Steps Shorter Review Cycles for New Investigators Last year: About 2,000 new investigators Feb 2007: 3,000 June 2007: 6,000 new investigators Nov 2007: All New Investigators (>12,000)

43 A Vision for Peer Review 1. Shorten the review cycle 2. Do more to recruit and retain more high-quality reviewers and decrease the burden on applicants and reviewers

44 Changes Impacting CSR Peer Reviews Applications Received R01s and R21s Reviewed by CSR Average Number of Applications Reviewed by Reviewers 5 Years Ago 46,000 21, Now 80,000 39,000 6

45 CSR s Growing Need for Reviewers 30,000 25,000 20,000 15,000 10,000 5, Fiscal Year

46 Near-Term Solutions for Recruiting and Retaining the Best Reviewers Require less travel by using electronic review modes Have Shorter Meetings Shorten Applications

47 Expanding Peer Review s Platforms Study Sections Electronic Reviews Telephone Enhanced Discussions Video Enhanced Discussions Asynchronous Electronic Discussions Necessity Clinical reviewers Preference Physicists, computational biologists New Opportunities Fogarty, International Reviewers Our Goal: 10% of all reviews to be electronic in 2007

48 The Advantages of Shorter Applications Operational Each reviewer can read more applications Study sections can be smaller More experienced reviewers can be recruited Cultural Reviews can be more focused on impact and innovation and less on approach and preliminary results

49 Shorter Applications Trans NIH Committee Communication and Support from Societies, Diseases Groups, Scientific Leadership 2 Retreats of NIH Directors Approval and Support of our Advisory Committee Survey of Scientists

50 NIH Guide Survey on Shorter R01 Applications Responses For Shorter Applications Against Shorter Applications Total Number 3,827 1,251 5,078 Percent 73% 27% 100% Survey ended on January 8, 2007

51 A new system? If we didn t have any peer-review system and we had to design one from scratch, what would it look like?

52 This is CSR

53 Coronary Heart Disease Age-Adjusted Death Rates in U.S.: Actual (blue) vs. Expected (yellow) 500 Deaths per 100, ,000 Deaths Prevented in 2000 ~ 1,329,000 Projected Deaths in 2000 Average annual investment per American ~$3.70 ~ 514,000 Actual Deaths in Year

54 National International Hope World Movie.mpg

55 National International Hope