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Preliminary Data and Establishing Independence. When am I Ready to Submit a Grant? . 2013 AATS Grant Writing Workshop. Yolonda L. Colson MD, PhD Associate Professor of Surgery Brigham and Women’s Hospital Harvard Medical School . You need P reliminary Data.
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Preliminary Data and Establishing Independence When am I Ready to Submit a Grant? 2013 AATS Grant Writing Workshop Yolonda L. Colson MD, PhD Associate Professor of Surgery Brigham and Women’s Hospital Harvard Medical School
You need Preliminary Data No matter what they tell you: Solid Preliminary Data is critically important for getting any NIH grant funded and will certainly help with Foundation and Career Development grants
PUBLISH THE PAPERS! You can only cite manuscripts that are published or accepted for publication. With current page limits, preliminary data which supports the significance, the hypothesis and/or your expertise should be published if at all possible
R21 Grants • Preliminary Data NOT required…but • In 2012, Review of 200 reviewed and scored R21 • 34.5% New Investigators (no prior NIH funds) • 93.5% included preliminary data • Only 1.7% of the funded applications lacked preliminary data
R21 Grants • No evidence R21 is good pathway for early stage investigators (ESI) • Overall R21 applications – 50% ESI • Of 200 reviewed/scored R21 – 34.5% ESI • No ESI Consideration (scoring bonus) • ESI Success rate was 18.8% • Compared to 35.1% for established investigators • No grant from an ESI without preliminary data was funded
You need Preliminary Data ^ High-Quality No matter what they tell you: State-of-the-Art Logical Novel Published
Do you have Preliminary Data? • Yes • Write it up and publish before Grant reviewed is best option • Consider R01 submission • No – Find way to generate preliminary data • Charity: Senior-level collaborator help with data generation • Stepping stool: Lead subproject on senior multi-project grant • Career Development Grants (K08,K23, K99, TSFRE etc) • Research supplement on another investigators R01 • Labor: Post-doc to generate data and publications • AREA grants: if institution received <$6M NIH funding/yr
Are you an Independent Investigator? • Required for R01 and R21 mechanisms • Criteria • Advanced Degree (MD or PhD) • Appropriate Academic Position (Asst Professor or above) • Publication as first or last author in respected journals or • Experience overseeing projects in field you are applying • Convince reviewers you are ready & able to lead w/o senior PI • Senior-level collaborator OK with expertise in different area • Harder if you share space in lab of senior person with same area of expertise – works better if they are mentor for K award • Publications establish independent expertise • Institutional commitment for dedicated space or resources establish recognition of independent value
Not Independent? • Find ways to bring an independent project to publication • Institutional support to generate and PUBLISH preliminary data • Conduct research as part of another grant • Lead subproject on senior multi-project grant (P01) • Serve as co-PI on an NIH grant • Research supplement on another investigators R01 or Diversity or Reeentry Supplements • Career Development Grants • (K08,K23, K99, TSFRE etc) • AREA grants
Purpose of Preliminary Data? • Establish Credibility • You and your collaborators • Show necessary skills and experience to do what you propose • Establish Feasibility of the project • Assess likelihood that research successfully done in time frame • Educate the Reviewer • What has been done in the field (especially by you) • What preliminary data is novel and advances the field • Why the proposed work is important • What question raised by the preliminary data will the proposed experiment answer? • Demonstrate continuity of your research that led to proposal • Proposed research follows logically from what you have published • Supports stated significance or hypothesis • “Wow” the reviewer and show you are uniquely qualified • Show them you have unique skills or insight, or are an expert in this field
Where Does Preliminary Data Go? • Actual data goes in Approach Section • Subsection under Research Strategy • Separate Subsection vs Integrated into each Aim • Describe or Highlight data in other sections • Specific Aims: • Refer to preliminary studies and new and highly relevant findings important to this project • Tie your preliminary data to the innovation of your proposal • “The proposed work is innovative as it draws on our novel discovery …..”
Where Does Preliminary Data Go? • Significance Subsection: • Establish significance by referencing published data in the field – Preferably your papers • “We formulated this hypothesis based on the literature and our preliminary data…..” • Link your preliminary data to the significance and problem you are studying • “Based on our recent identification of this protein, a major goal for this application is to elucidate the function of this protein.” • “We are equipped to study this problem as we have significant experience in analysis of ….. • Innovation Subsection: • Summarize novel findings shown in more detail later
Where Does Preliminary Data Go? • Approach Subsection: • Can be separate subsection labeled Preliminary Datavs. • Integrating relevant data within each Aim • Be sure to mark description clearly with bold subheading • Citations should be of papers by you and/or your collaborators whenever possible • Avoid excess experimental detail • Keep methods simple and brief but SHOW RESULTS • Refer to your publications that describe the detail methods • Goal for R01 application: • Preliminary data AND a publication for EACH AIM. • Not so extensive as to have already finished proposal
Preliminary Data Basics • Purpose: • Present data with a purpose, not just data • Credibility: Expertise in state-of-the-art techniques needed for proposal • Feasibility: Can collect necessary data and get published • Support: Significance, problem, hypothesis etc. • What’s Next?: Use Data to Build and Support your Proposal • Actual data figures should be in Approach section only
Preliminary Data Basics • Appearance: • Don’t make the Reviewer struggle to see your data • Illustrations and Figures • High-quality • Readable text in legend, axis and data labels • Well-organized • Consistent format, size, font and layout • Readable in black and white