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---+Vanderbilt Grantsmanship Advantage (VGA)  
---+A Proposal for Maximizing Grant Funding in the School of Medicine
---++This initiative will be coordinated through the office of the Associate Dean for Clinical and Translational Scientist Development and will be a joint effort with the Office of Research and the Department of Biostatistics.
   * [[FuturePlanGrant][Future Ideas]]

Two of the most important goals of the Department of Biostatistics are increasing the quantity and quality of research in the School of Medicine.  In an era of falling pay lines and increased competition, the incremental benefit of advance planning and better experimental designs, measurement procedures, and statistical analysis plans has even more impact on increasing the probability that a proposal will be funded.  It is obvious from a review of pink sheets (see [[http://www.annals.org/cgi/reprint/142/4/274.pdf Inouye SK, Fiellin DA.  An evidence-based guide to grant proposals for clinical research]]) that statistical problems remain in many proposals.  Strong biostatistical involvement early in the proposal process, as well as the involvement of professional editors, clearly benefit proposals.  For example, in a statistical review of 67 grants submitted to the Agency for Healthcare Research and Quality's Health Services Developmental Grants Study Section in 1994-1996, a significant relationship was found between the quality of the statistical design and analysis plan (rated on a 0-10 scale before knowing reviewers' scores) and the average priority score given by reviewer's assigned to the proposal. 

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To address these issues, the Department of Biostatistics proposes a new approach outlined below.
---++Phase I (Begin June 1, 2006)
   1 The Department should become a more visible component of the research enterprise and have a second reporting line to the [[https://medschool.mc.vanderbilt.edu/oor Office of Research]] with increased communication and coordination with the offices of Jeff Balser, Gordon Bernard, and the office of [[http://www.vanderbilt.edu/oor/gcm Grants and Contracts Management]].
   1 [[http://www.vanderbilt.edu/oor/gcm Grants and Contracts Management]] will provide continuous data to Biostatistics about grant proposals, submissions, resubmissions, reviews, and funding decisions.  These data will be analyzed continuously to identify opportunities for increasing the number of grant proposals (e.g., by analyzing secular trends by department).  These data will also be used to study the efficacy of measures described below.
   1 Jeff Balser or Gordon Bernard will send an e-mail to all faculty and fellows on the first of each even-numbered month informing them that anyone who plans to submit an NIH R01 grant proposal within the following year should notify the Office of Research.  The email will be set up in a way that one can simply hit "reply" and the email will be sent to Lynne Hutchison who will enter these names in a database.  The Department of Biostatistics will also have access to this database so that PIs covered by the Collaboration Plan will be contacted to notify them that biostatistical assistance is already available for them.
   1 The Office of Research and the Department of Biostatistics will launch a special program to assist first-time investigators in applying for NIH grants for the October 1, 2006 deadline, designed as follows.  Phase I will target only investigators who have never had an R01 funded.  We estimate there will be 20 of these first-time R01 investigators.  The program will cover initial submissions and resubmissions.
   1 In addition to the general email described above, a targeted email will be sent to first-time investigators who have never had an R01 funded, asking those who plan to submit an R01 on 10/1/06 to reply so that the appropriate support and services can be provided.  
   1 A database will be created of the 20 or so first-time PIs who plan to submit an R01 on 10/1/06.
   1 An R01 funding task force will be created starting with Frank Harrell, Dan Byrne, Lynne Hutchison, and Nancy Brown.  This group will meet every 2 weeks to oversee this project.  The task force will also help by providing “matchmaking services” to connect PIs with collaborators and mentors.
   1 An online library of the pdf version of funded Vanderbilt R01s will be created as a resource for Vanderbilt investigators to use as models while writing their grants.  This information will be protected by both VUNET ID and e-password.  The web site will be shared with the 20 PIs in the database.  Most Vanderbilt investigators will agree to have their funded R01 used for this purpose, as they will also have access to this library.     
   1 Dan Byrne and Lynne Hutchison will write and edit a set of guidelines “How to write a successful R01.”  A working draft of this will be ready on 7/1/06.  The guidelines are based on analysis of pink sheets and contain advice on how to avoid common study section criticisms.  These also contain template language that can be used as a starting point.  In addition, successful grant writers will be asked to contribute to these guidelines.  The guidelines will not be published or posted on the Internet.  They will only be shared with Vanderbilt investigators writing grants, biostatisticians, and medical writers.  To accomplish this Dan Byrne and Lynne Hutchison need permission to access the summary statements for all Vanderbilt grant applications in eRA commons.  They would sign a statement describing how confidentiality will be maintained.  These guidelines will also include information from pink sheets of basic science grant applications and input from highly successful basic science researchers to provide advice to grant writers on matters such as the appropriate amount of biostatistical detail and support.  
   1. A binder of R01 grant writing resources will be sent to each of the 20 PIs on 7/5/06.  This binder will contain:
         * The guidelines “How to write a successful R01”
         * Instruction and password to access the online library of funded R01s.
         * A list of Vanderbilt and other resources available to help
         * A timeline of when to meet with biostatisticians and medical writers, etc.
         * A description of the pre-review process.
         * A reprint of the article “Inouye SK, Fiellin DA. An evidence-based guide to 
    grant proposals for clinical research.  Ann Intern Med. 2005;142:274-282.  
    http://www.annals.org/cgi/reprint/142/4/274.pdf
         * A list of upcoming workshops of interest to grant writers.
   1 On 7/15/06, a questionnaire will be sent to all 20 PIs to learn about other needs and services they would like to see offered.
   1 The 20 R01 proposals will be randomly assigned to the 10 most senior biostatisticians currently available to help in the department.  Each biostatistician will also be teamed up with a more junior biostatistician.  Each of the 10 teams will be responsible for assisting the PIs with their grants.  This will help junior biostatisticians learn how to prepare a successful grant application.
   1 All investigators agreeing to start the planning process for the submission at least 2.5 months before the deadline (i.e., before July 15, 2006) will qualify for personalized assistance as long as they agree to hold at least 5 planning and writing meetings with the research team and a <nop>PhD and MS biostatistician.
   1 The 20 PIs will be asked to submit a complete version of their application to Lynn Hutchison on August 28, 2006 (5 weeks prior to the submission date).  All 20 applications will receive an internal pre-review by a Vanderbilt "Study Section".  This study section will be assembled by the task force and will include experienced grant writers, scientists, biostatisticians and medical writers.  These internal reviewers will provide pink-sheet like feedback to the 20 PIs by September 4, 2006.  The School of Medicine will help create this standing mock study section consisting of 40 experienced researchers (of whom 6 are biostatisticians).  Four reviewers will jointly review each submitted grant.  The reviewers will be expected to spend one hour reading the proposal before the meeting, then two hours meeting as a group with the PI and her research team.  Those reviewers not in the home department of the PI will have $400 added to their discretionary funds per review. 
   1 When the PI is in a group already participating in Biostatistics' [[CollabProt][collaboration plan]], the Department is already being funded for this work.  Otherwise, Biostatistics will strictly account for time spent by biostatisticians in assisting with proposal development and writing, and this amount of salary plus fringe benefits will be paid to Biostatistics by the Office of Research.
   1 Lynn Hutchison and Research Communication Services will provide editorial assistance starting 8 weeks before submission (August 1, 2006).
   1 During July 2006, an intern in the Department of Biostatistics, Diane Perhac will review a set of successful and unsuccessful R01 grants from Vanderbilt using the eRA commons and create a database.  Under the guidance of Dan Byrne and Frank Harrell she will perform a statistical analysis of the factors that predict success.
   1 A system of incentives and rewards will be created to foster increased collaboration with grants.  In the spring of 2007, a celebration of those who where successful in obtaining R01s from the 10/1/06 submission will be held.  This information will also be submitted to the Reporter.
---++Email from Dr. Brown.
Vanderbilt has experienced unprecedented growth in the number of K awardees over the last few years. These motivated, talented individuals will submit first R01s at a tough time in NIH funding.  While many of the institutes have adopted programs to help the first-time R01 submitter, we would like to maximize the grant-writing support we provide as an institution.  To this end I am writing to ask for your help in two areas.
   1 We would like to provide a library of grants with the best priority scores in the areas of basic science, clinical and translational research, health outcomes, and epidemiology.  Grants would be available at a password protected electronic site.  Names of individuals who had accessed the grants would be provided to the provider of the grant on quarterly basis.
   1 We would like to provide an internal review for all junior faculty members who are submitting first R01s, beginning with the October 1/November 1, 2006 funding cycle.  For their grants to be eligible for review, faculty would have to provide a complete draft by August 25th .  We are asking for senior faculty to read one grant during the last week of August and to meet for a few hours on September 1st to provide comments.  In addition to your comments, comments from the meetings would be conveyed to the faculty by a scientific writer.  Please respond to the following questions via survey monkey:
https://www.surveymonkey.com/s.asp?A=128907700E43391

Nancy J. Brown, MD
Assoc Dean for Clinical and Translational Scientist Development
343-1745
Topic attachments
I	Attachment	Action	Size	Date	Who	Comment
png	statqual.png	manage	3.6 K	27 Apr 2006 - 13:57	FrankHarrell	Priority scores vs. stat quality in review of 67 grant proposals
Topic revision: r17 - 26 May 2006, DanielByrne
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