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Your First Research Grant: The NCI R21 Quick-Trial

How will you fund your trial?. I already have grant support for the trial.I intend to apply for a grant.I will ask my department chair for funds.I will invest $10 in Powerball every week.I don't know.. How long will it take to complete your trial?. 1-2 yrs3-5 yrs> 5 yrsUntil my fellowship end

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Your First Research Grant: The NCI R21 Quick-Trial

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    1. Your First Research Grant: The NCI R21 Quick-Trial Donn C. Young, Ph.D. Biostatistics Core The Ohio State University Comprehensive Cancer Center Email: young.7@osu.edu

    2. How will you fund your trial? I already have grant support for the trial. I intend to apply for a grant. I will ask my department chair for funds. I will invest $10 in Powerball every week. I don’t know.

    4. How long will it take to complete your trial? 1-2 yrs 3-5 yrs > 5 yrs Until my fellowship ends or my tenure clock alarm goes off I don’t know

    6. Have you inherited a incomplete trial developed by another PI? No Yes and will work hard to complete it Yes, but who cares

    8. Fellows: How old are you? = 26 yrs 27-28 yrs 29-30 yrs 31-32 yrs 33-34 yrs 35+ yrs I don’t know

    10. Junior Faculty: How old are you? = 30 yrs 31-32 yrs 32-33 yrs 34-35 yrs 36-37 yrs 38+ yrs I don’t know

    18. R21 Quick-Trials: WHAT? Support exploratory clinical trials of novel cancer therapies or diagnostic/biologic evaluation NCI Program Announcement PA 06-0451 2-years of funding Limited to $250,000 per year / Modular grant Non-renewable Electronic submission only – NO PAPER ALLOWED! Submission dates: Apr 9, Aug 9, Dec 9 Rapid turnaround: Submission > Fund = 8 months

    19. R21 Quick-Trials: WHY? To generate data on a novel therapy and/or biologic mechanism Requires NO preliminary data – only need to justify use of human subjects Can’t be renewed = high turnover 2-year limit = results for presentation/publication Check “NEW INVESTIGATOR” box on cover

    20. R21 Quick-Trials: What’s it cover? Pilot, Phase I, Phase II trials: treatment, prevention, diagnostic, biological investigations Local, investigator-initiated Trials with partial NCI support [U01, U10] Industry-sponsored trials FOCUS on translational research Must: 1] propose a clinical trial or 2] propose monitoring or lab studies linked to a cancer clinical trial

    21. R21 Quick-Trials: What’s it cover? Drugs/agents Biologics Radiation Heat Surgery Herbal therapies Dietary supplements Bioactive food components Unconventional interventions Image guidance for treatment or drug delivery Diagnostic/biologic evaluation

    22. R21 Quick-Trials: What’s it cover? Salary efforts: PI / co-investigators Biostatistician Research nurse Data manager Cost of administrative/regulatory support Cost of treatment / patient care / correlative studies Cost of patient recruitment Advertising for patients/subjects

    23. R21 Quick-Trials: Organization Specific Aims – 1 page or less Limit it to 2-3 aims / Use concise statements! Remember – you’ve only got 2 years to do it Background & Significance – 2 pages or less Rationale & justification for the trial Research Plan items 2-5 – 15 pages maximum Don’t forget statistics! Appendix – clinical protocol and up to 5 relevant publications

    24. R21 Quick-Trials: Review Criteria Significance Approach Innovation Investigator Environment

    25. R21 Quick-Trials: Review Criteria Protection of human subjects Data and safety monitoring plan Inclusion of women, minorities & children Care and use of vertebrate animals Biohazards Privacy of individually identifiable health info

    26. R21 Quick-Trials: The Review Assigned to Study Section Reviewers: 1 – Primary 2 – Secondary / Readers 1 – Biostatistician Entire Study Section votes on submission Initial Triage: an attempt to identify those proposals with little chance to receive a fundable priority score – goal is to triage ˝

    27. 1 R01 GG00029-01 PI: Mendel, G. SUMMARY EVALUATION: This unusual application by a new investigator proposes experiments to elucidate the principles of inheritance. Overall, the proposed project is unlikely to contribute to our understanding of inheritance, much less to the establishment of any ‘principles of inheritance.’ The experimental approach is inappropriate, the preparation of the investigator poor, and the chances for success slim.

    28. R21 Quick-Trials: Not funded? Less than 10% of applications are funded at first submission / ‘new investigator’ = 6% funded You get 3 tries: original and 2 amended Goal for first submission: Use critique/pink sheets to re-write the grant Stick to responding to critique – don’t introduce new aims or approaches

    29. R21 Quick-Trials: More Info NCI Office of Grants Administration: http://www3.cancer.gov/admin/gab/ NCI Grant Application and Review Process: http://www.nci.nih.gov/researchandfunding/grantprocess NCI R21 Program Announcement: http://grants.nih.gov/grants/guide/pa-files/PAR-06-451.html NIH Office of Extramural Research http://grants.nih.gov/grants/OER.htm NIH OER New Investigators Program http://grants.nih.gov/grants/new_investigators/index.htm

    31. Your First Research Grant: The NCI R21 Quick-Trial Thanks! Any Questions?

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