Preliminary Results and Research Design and Methods

1
Preliminary Results and Research Design and
Methods

• George Leikauf
• University of Cincinnati
• OR
• THE TRUTH HURTS
• WHAT THE EXECUTIVE SECRETARY WONT TELL YOU
• YOU CAN TRY IT YOUR OWN WAY BUT THE REVEIWERS
  PROBABLY WONT LIKE IT
• LIFE OR DEATH ON THE TENURE TRACK

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Preliminary Results

• The overall purpose of the research plan is to
  describe the what, when, why, and how of the
  proposal
• Preliminary Results contributes to both the why
  and how
• IT IS ALL ABOUT
• YOU,
• YOUR WORK,
• YOUR JUDGEMENT, and
• HOW YOU INTERPRET DATA

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Preliminary Results

• This section is not mandatory for new
  applications
• BUT IT IS VIRTUALLY IMPOSSIBLE TO OBTAIN A
  FAVORABLE REVIEW WITHOUT STRONG PRELIMINARY
  RESULTS
• In a competing renewal application, this section
  becomes a progress report describing studies
  performed during the last grant period
• UNLESS YOU HAVE OUTSTANDING PROGRESS CONSIDER A
  NEW PROPOSAL

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Preliminary Results

• Recommended length
• 6 - 8 pages

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Preliminary Results

• Content In a new application, the preliminary
  results contributes to why of the proposal
• Provide experimental support for the hypothesis
  and the research design
• Brief description of older published studies by
  the applicant that provide important background
  information relevant to the proposed project

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Preliminary Results

• Content In a new application, the preliminary
  results contributes to how of the proposal
• Present unpublished studies by the applicants to
  establish
• the feasibility and importance of the project
• the applicants competence and experience with
  the experimental techniques to be used in the
  project

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Preliminary Results

• Content May also include
• Results of previous studies by the applicant not
  directly relevant to the proposed project that
  demonstrated the applicants competence and
  experience with the experimental techniques to be
  used in the project
• CLEARLY IDENTIFIED AS SUCH.
• PUBLISH IN RIGOROUS JOURNALS
• BETTER PLACED IN BACKGROUND?

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Preliminary Results

• Suggestions
• Organization Link directly with Specific Aims
  (i.e. Use headings Preliminary Data Supporting
  Aim 1 To determine)
• SUPPORT EACH AND EVERY AIM!
• Include all Tables and Figures necessary for the
  presentation of preliminary results
• TYPICALLY ORDINATE (Y AXIS) IS THE INDEPENDENT
  VARIABLE.

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Preliminary Results

• Suggestions
• Full-size glossy photographs of materials such as
  electron micrographs, gels, etc. may be included
  in the appendix, but only if a photocopy (reduced
  in size, as appropriate) is included in the body
  of the Research Plan
• DONT EXPECT APPENDICIES TO BE READ

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Preliminary Results

• Suggestions
• Figures and Figure legends must be legible.
• Observe limits on type size given in the
  application instructions, but beyond this rule,
  the critical factor is whether the data are
  legible and convincing to the reviewers
• REVIEWERS ARE NOT IMPRESSED BY SMALL DIFFERENCES

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Preliminary Results

• Suggestions
• All data must be analyzed with proper statistical
  methods
• STATISTICAL VS. MEDICAL SIGNIFICANCE
• Don't show raw data or data you have not fully
  analyzed

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Preliminary Results

• Suggestions
• Dont dwell on results already published
• PUBLISHED RESULTS CAN PROVE COMPENDENCE
• BUT PUBLISHED RESULTS REDUCE INNOVATION

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Preliminary Results

• Suggestions
• Present result objectively
• USE SUPERLATIVES SPARINGLY DRAMATIC
  ABSOLUTELY CRITICAL IMPRESSIVE
• Dont be overly impressed by your own findings
• HAVE CONFIDENCE IN YOUR REVIEWER

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Preliminary Results

• Suggestions
• Make sure you are ready
• Collect at least 1-2 years of preliminary data
• Consider publishing 2 manuscripts in the area to
  make your research questions more robust

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Preliminary Results

• Editing
• Consider including mainly data that demonstrate
  expertise with the more difficult methods
• Combine figures into multiple panels
• Place Tables into text (present data
  parenthetically)

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Preliminary Results

• Editing
• Eliminate any figure that will initiate a debate
  in the mind of the reviewer
• Dont ignore different possible interpretations
• Be as cautious as is prudent

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Preliminary Results

• Editing
• Word choice Our findings suggest, imply,
  support , or indicate
• Present your results (even if they are
  preliminary) in as professional a manner as
  possible, with clear and complete figure/table
  legends, calibrations, statistical analysis, etc.

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Research Design and Methods

• The overall purpose of the research plan is to
  describe the what, when, why, and how of the
  proposal
• Research Design and Methods contributes to what,
  when, why, and how
• APPROACH gt SIGNIFICANCE gt INNOVATION

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Research Design and Methods

• Recommended length
• 20 pages
• TOTAL LIMIT IS 25 PAGES SO, YOU CAN NOT GIVE
  EVERY LITTLE DETAIL IN METHODS SECTION
• SOME REVIEWERS ARE TECHIQUE DRIVEN AND MAY MAKE
  MOUNTAINS OUT OF MOLE HILLS

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Research Design and Methods

• Content Research Design and Methods contributes
  to what, when, why, and how
• What? Experimental Model and Specific Aims
• REAGENTS IN HAND AND EXPERIENCE
• When? Sequence of Specific Aims
• INTERACTING BUT INDEPENDENT
• Why? Meaningfulness of results, and their
  relationship to hypothesis
• HUMAN HEALTH SIGNIFICANCE
• How? Experimental Design and Methods
• STATISTICAL APPROACH

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Research Design and Methods

• Content
• Description of any new methodology used and why
  it represents an improvement over the existing
  ones
• Detailed description of specific methods to be
  employed
• Projected sequence of Specific Aims and timetable

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Research Design and Methods

• Content
• Experimental design (how the research will be
  carried out)
• Detailed discussion of the way in which the
  results will be collected, analyzed, and
  interpreted

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Research Design and Methods

• Content Detailed discussion of the way in which
  the results will be collected, analyzed, and
  interpreted
• Expected results, and alternative approaches that
  will be used if unexpected results are found
• Discussion of potential difficulties and
  limitations and how these will be overcome or
  mitigated
• DONT SAY THERE WONT BE ANY

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Research Design and Methods

• Suggestions
• Organize the sections in this part of the
  application to correspond to the numbers of the
  Specific Aims
• Give sufficient detail
• DONT ASSUME THE REVIEWER WILL KNOW HOW YOU
  INTEND TO PROCEED

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Research Design and Methods

• Suggestions
• Avoid excessive experimental detail by referring
  to publications that describe the methods to be
  employed
• MIXING LEVEL OF DETAIL CAN BE CONFUSING
• Pull all the details on Methods together in the
  end of the proposal

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Research Design and Methods

• Suggestions
• Publications cited should be by the applicants,
  when reasonable
• Citing publication by others establishes that you
  know what method to use, but citing your own (or
  collaborator) establishes that the applicant
  personnel are experienced with the necessary
  techniques

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Research Design and Methods

• Suggestions
• If relevant, explain why one approach or method
  will be used in preference to others. This
  establishes that the alternatives were not simply
  overlooked
• Give not only the "how" but the "why"

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Research Design and Methods

• Suggestions
• When employing a complex technology for the first
  time, take extra care to demonstrate familiarity
  with the experimental details and potential
  pitfalls
• What have you (and your collaborators) done to
  establish the feasibility of what you are
  proposing to do?

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Research Design and Methods

• Suggestions.
• Add a co-investigator or consultant experienced
  with the technology if necessary
• Document proposed collaborations and offers of
  materials or reagents of restricted availability
  with letters from the individual involved

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Research Design and Methods

• Suggestions.
• Use reagents in hand, proposing to generate a
  reagent (e.g., knockout mouse lines) is dangerous

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Research Design and Methods

• Suggestions.
• Be sure to explain how the results to be obtained
  will be used to test the hypothesis
• Discovery science (genomics/proteomics) is harder
  than Hypothesis-driven science to support
  Complete an initial discovery phase should lead
  to hypothesis.

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Research Design and Methods

• Suggestions.
• Include Timeline to demonstrate the objectives
  are attainable within the stated time frame
• Don't bite off more than you can chew. A small,
  focused project is generally better received than
  a diffuse, multifaceted project

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Summary

• You have succeeded if you demonstrate to the
  reviewer that YOU
• Can design logical, well-controlled experiments
• Present your results in a clear and thoughtful
  manner

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Summary

• You have succeeded if you demonstrate to the
  reviewer that YOU
• That you demonstrate what you (and your
  collaborators) have done to establish the
  feasibility of any new methods you are proposing
  to do in the proposal

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Summary

• You have succeeded if you demonstrate to the
  reviewer that YOU
• Are experienced (hopefully published) with most
  of the experimental techniques proposed in the
  application

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Summary

• You have succeeded if you demonstrate to the
  reviewer that YOU
• Have you clearly described how will the research
  be accomplished?
• Describe Who? What? When? Where? Why?

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Conclusions

• The assessment of the Preliminary Results
  and the Research Design and Methods will largely
  determine whether or not the proposal is
  favorably recommended for funding.
• APPROACH gt SIGNIFICANCE gt INNOVATION