Preliminary Studies

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Preliminary Studies

• Jay F. Piccirillo, MD, FACS
• Professor and Director
• Clinical Outcomes Research Office
• Department of Otolaryngology Head and Neck
  Surgery
• Washington University School of Medicine
• St. Louis, Missouri

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Purposes

• Support scientific basis for the aims of the
  grant
• Demonstrate that research can be done
  (successfully) and that you can do it (possess
  the technical capability)
• Reviewers use the preliminary studies section to
  assess your competence to do the work.

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Demonstrating The Feasibility Of Your project

• No matter what they say (ie., R03, R21) you
  ALWAYS need pilot data
• Preliminary data help make case that research can
  be done
• NIH wants to fund research that has high
  likelihood of being successful
• For K award, data can come from mentors lab
• Trainee-derived data is very good

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• By providing preliminary data, build reviewer
  confidence that you can handle the technologies,
  understand the methods, and interpret results
• Interpret preliminary results critically
• Give alternative meanings to the data to show
  you've thought the problem through and will be
  able to meet future challenges
• If you don't do this, the reviewers will!

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• Include enough information to show you know what
  you're talking about.
• The more complex the project, the more data you
  need.
• Tell them how your early work prepared you for
  the new project.
• Though you may include other people's
  publications, focus on your preliminary data or
  unpublished data from your lab. If you must
  present results from other labs, make clear which
  data are yours and which are not.
• Include previous experience that shows you can
  direct the proposed research and achieve its
  aims.

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• Each subsection should be headed with topic
  sentence or phrase that concisely conveys
  observation and conclusion
• Headings should be underlined or bold font

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Amount Of Data To Include

• The larger the project (read greater ), the
  greater the amount of preliminary data
• Smaller projects (R03,R21, K awards) less detail
  data required
• Calibrate your presentation to the goals of the
  project and the RFA
• R01 emphasis on meaningful results
• R03,R21, K high-risk exploration or training of
  new scientists

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Format

• Subsection should contain data in the form of
  Figures and Tables
• Data should
• Support a hypothesis
• Show a technique
• Both
• Self-explanatory, concise
• Bottom Line Tools to approach the aims are in
  place and functional in your laboratory or
  through close collaborators

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Supporting Hypotheses

• Present evidence that shows your hypotheses are
  plausible, feasible, and experimentally
  approachable
• Tell a story that steers reader toward
  understanding the reasons behind the hypotheses
• Preliminary data section points to the next
  logical step ? Your planned research

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Show A Technique

• Methods central to the grant proposal should be
  demonstrated and shown to be possible
• Level of methodological detail depends on
• The degree of novelty of technique standard
  techniques require less information,
  novel/unvalidated techniques require more
  information
• Level of investigator seasoned investigator will
  present less detail, novice presents more
• Your challenge to convince reviewers you posses
  or can acquire abilities, techniques, equipment,
  and materials to perform all the experiments
  listed in Research Design and Methods

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Organization

• Conclude each section that summarizes the point
  of the section
• May seem redundant but makes the point
• Directness reinforces and unifies your ideas
  give whole application cohesiveness

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Common Errors

• Failure to indicate source of data
• Unnecessarily complicated figures or tables
• Showing data not clearly related to the proposed
  work
• Poor organization
• Omission of important points or procedures

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Failure To Indicate The Source Of Data

• All data should be provided directly from your
  work or collaborators
• Source of data clearly indicated and described
  (you vs. collaborators)
• For training grants bulk of data from mentors
  lab
• For established investigators bulk of data from
  investigator's lab

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Unnecessarily Complicated Figures or Tables

• Clarity is key!
• Avoid figure with multiple arms making multiple
  points
• Each figure should make one point

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Do Not Show Data Unless Clearly Related To The
Proposed Work

• ALL data in this section should related directly
  to the proposed hypotheses and/or techniques
• Information that is peripheral detracts
• This section provides crucial transition between
  Background and Significance and Research
  Design and Methods

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Poor Organization

• Logical flow avoid random assortment of
  experiments
• Organization skill in this section provides
  positive reflection of your ability to think and
  assemble data

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Omission Of Important Points Or Procedures

• New ideas or techniques utilized in the
  experimental plans should be addressed in this
  section
• Supporting data needs to be cited
• This section should stand alone avoid use of
  appendices