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Archived File

Archived File. The file below has been archived for historical reference purposes only. The content and links are no longer maintained and may be outdated. See the OER Public Archive Home Page for more details about archived files. Review of Special Topics: Clinical Research.

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Archived File

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  1. Archived File The file below has been archived for historical reference purposes only. The content and links are no longer maintained and may be outdated. See the OER Public Archive Home Page for more details about archived files.

  2. Review of Special Topics:Clinical Research Theodore Kotchen, M.D. Special Advisor on Clinical Research, CSR Professor of Medicine and Epidemiology and Associate Dean for Clinical Research, Medical College of Wisconsin

  3. Role of CSR Advisor for Review of Clinical Research • To determine if grant applications for “clinical research” are disadvantaged in the NIH peer review process • To function as a liaison with clinical societies

  4. Median priority scores and funding of R01 applications (May/Oct 2002 Councils) * P < 0.001

  5. Stratification of “Clinical” Research • Mechanisms of human disease (“bench to bedside”) • Clinical trials and other clinical interventions • Development of new technologies • Epidemiologic studies • Behavioral studies • Health services research • Utilization of human tissue

  6. Median Scores and Funding by Category of Clinical Research * p <0.01 vs HS-; R01 applications, October 2002 Council

  7. Have differences in peer review outcomes for clinical and non-clinical applications persisted over time?

  8. Why Don’t Clinical Applications Fare As Well • Potential review factors • “Density” of clinical applications? • Greater cost? • Composition of review group? • Inappropriate review criteria? • Potential application factors • Weaker science? • Research more difficult? • Inadequate grant preparation

  9. Do peer review outcomes for “clinical” R01 applications differ in study sections that review either relatively low or relatively high percentages of clinical applications?

  10. Is the a relationship between requested direct costs and peer review outcomes?

  11. Do study section members with personal experience conducting clinical research evaluate R01 applications differently from reviewers with no clinical research experience?

  12. Why Don’t Clinical Applications Fare As Well • Potential review factors • “Density” of clinical applications? • Greater cost? • Composition of review group? • Inappropriate review criteria? • Potential application factors • Weaker science? • Research more difficult? • Inadequate grant preparation?

  13. Median priority scores and funding of clinical R01 applications (May/Oct 2002 Councils) * P < 0.001

  14. Applications Submitted by and Awarded to MDs

  15. Current CSR Initiatives • Track review outcomes, by study section, for clinical and basic applications • Developed supplementary guidelines for preparation of clinical applications • Created two clinical study sections (consider others) • Consider strategies to increase pool of clinical investigators to serve on study sections • Continue to interact with clinical societies

  16. Presentations • Endocrine “sister societies” (E. Postow, M. Martin)—3/03 • Mayo Clinic---4/03 • K30 Program Directors Assoc---4/03, 4/04 • NASPGHAN---10/03 • Emergency Medicine MDs (D. Schneider)—11/03 • AHC Clinical Research Forum---11/03 • American GI Assoc---5/04 • University of Arkansas—10/04 • University of Pennsylvania—12/04 • Association of American Medical Colleges—2/05

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