Common Flaws in Initial Applications

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Common Flaws in Initial Applications
Britt Reid, D.D.S., Ph.D. Chief, Modifiable Risk
Factors Branch Epidemiology and Genetics Research
Program Sarah Kobrin, Ph.D., M.P.H. Program
Director Applied Cancer Screening Research
Branch Behavioral Research Program
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Why first application is critical

• Sets tone
• Establishes parameters for reviewers
• Now more important than ever (no A2s!!!)

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Overly Ambitious Specific Aims

• Too many specific aims
• Too much complexity or scope
• For an R03
• For an R21
• For your career stage

4
Specific Aims too Interdependent

• If one aim cannot be accomplished are other aims
  futile?
• Use sub-aims?
• Can each aim be accomplished irrespective of the
  results of the other aims?
• Accept or reject each hypothesis

5
Missing Theoretical Framework or Conceptual Model

• Page limitations are tight, but never too tight
  for a diagram.
• Diagrams more efficient than you may think
• Conceptual model creates comfort for reviewers
• Published model best, modify if needed
• De novo model better than none
• Conceptual model sets up analysis plans
• Effect modifiers and confounders
• Establishes levels and outcomes for analysis

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Insufficiently Detailed Methods Section

• Can someone recreate your study using only the
  details in the application?
• Clinical researchers- do not try to subvert page
  limitations with overuse of human subjects
  section
• Reference established methods/protocols with
  succinct summaries where possible

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Power Analysis for Each Specific Aim

• Each aim must have an analysis plan and
  power-and-sample-size section.
• Statisticians frequently included in study
  sections
• epidemiological applications
• clinical applications

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Analysis Plan Not Well Developed

• Does analysis plan follow the conceptual model?
• Does each step follow logically from the next?
• Can reader do the analysis using only your
  instructions?

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Missing Limitations Section

• What other methods are available and why did you
  pick the one you did?
• What questions will this not address that may be
  addressed with the next study?
• What could go wrong?
• Recruitment
• Equipment failure in the field
• What are the back-up plans?

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General Sloppiness

• Spelling
• Grammar
• incomplete sentences
• Incorrect references
• Consistency
• Numbers easiest for reviewers to spot
  inconsistencies

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Uninformative Abstract

• Abstract is most commonly read section of
  application everything should be there
• Include research questions
• Emphasize methods
• Design
• Sample
• Analyses
• Statement of implications
• Limit literature review or background information

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Missing Support Letters

• Any participating organization should send a
  support letter
• Your word is not sufficient evidence
• Letters provide evidence of
• Feasibility
• Readiness to get running start
• Organization

13
Mismatched Team Expertise with Objectives

• All expertise needed for project should be
  clearly described
• How that expertise is embodied by team members
  (including yourself)
• Justification
• Formal training
• Publication records
• Roles on previous funded research

14
Inappropriate Literature Review

• Review literature to construct argument, not
  review whole field
• Read study section roster and ALWAYS cite
  anything relevant published by potential
  reviewers
• Cite recent literature be wary of out-of-date
  citations

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Human Subjects Issues

• Know NIH human subjects review criteria
• Justify recruitment (or lack) of
• Women
• Minorities
• Children

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Thank You!

• Questions