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8/8/2019 Turgeon- July 31st
1/30
Research PlanResearch Plan
Judith Turgeon, Ph.D.
Division of Endocrinology,
Clinical Nutrition, and Vascular Medicine
Judith Turgeon, Ph.D.
Division of Endocrinology,
Clinical Nutrition, and Vascular Medicine
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Common sense
Careful planning
Intense effort andlots of rewriting
A reviewer friendly
approach
Common sense
Careful planning
Intense effort andlots of rewriting
A reviewer friendly
approach
Writing a successful
scientific proposalrequires
Writing a successful
scientific proposalrequires
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Basic Tenets of Scientific Writing(from A. Coelho, Review Policy Officer, NIH)
Basic Tenets of Scientific Writing(from A. Coelho, Review Policy Officer, NIH)
Understand Agency Mission
Understand Peer Review
Secure Collaborators for areas in which youlack experience and training
There are no competitors in science, there onlyare potential Collaborators
Grant writing is a learned skill
Understand Agency Mission
Understand Peer Review
Secure Collaborators for areas in which youlack experience and training
There are no competitors in science, there onlyare potential Collaborators
Grant writing is a learned skill
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Care and Handling of Reviewers(from Coelho, NIH)
Care and Handling of Reviewers(from Coelho, NIH)
Organize, dont be sloppy, use readable fonts
Make it easyfor them to understand things
Make it easyfor them to find things
Dontmake them work hard
Make it easyfor them to be your advocate
Dont treat them like idiots
Organize, dont be sloppy, use readable fonts
Make it easyfor them to understand things
Make it easyfor them to find things
Dontmake them work hard
Make it easyfor them to be your advocate
Dont treat them like idiots
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IfIcould explain it to the ordinary
person, it wouldnt have been
worth the Nobel Prize.
IfIcould explain it to the ordinary
person, it wouldnt have been
worth the Nobel Prize.
Richard Feynman, to areporter from People
magazine, 1985
Richard Feynman, to areporter from People
magazine, 1985
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Research Grant Application
Usual Content
Research Grant Application
Usual Content
Specific Aims
Background and Significance Preliminary Data (new application) or
Progress Report (renewal application)
Research Design and Methods
Subjectshuman / vertebrate animal
Literature Cited
Specific Aims
Background and Significance Preliminary Data (new application) or
Progress Report (renewal application)
Research Design and Methods
Subjectshuman / vertebrate animal
Literature Cited
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Specific AimsSpecific Aims
Research Design & MethodsResearch Design & Methods
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Keep it simple
Clearly articulate the HYPOTHESIS
Avoid the over-ambitious label
Keep it simple
Clearly articulate the HYPOTHESIS
Avoid the over-ambitious label
Specific Aim Guidelines
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Avoid the over-ambitious label
not necessary to show that you have
considered all possible ways to answer
the question (save some options for renewal)
5-yr grant application doesnt necessarily
mean 5 specific aims
be realistic
Avoid the over-ambitious label
not necessary to show that you have
considered all possible ways to answer
the question (save some options for renewal)
5-yr grant application doesnt necessarily
mean 5 specific aims
be realistic
Specific Aim Guidelines, cont.
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Keep it simple
Clearly articulate the HYPOTHESIS
Avoid the over-ambitious label
Connect the aims thematically
Keep it simple
Clearly articulate the HYPOTHESIS
Avoid the over-ambitious label
Connect the aims thematically
Specific Aim Guidelines
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Connect the aims thematically
Possible models:
each aim presents a different approach or
perturbation to test a central hypothesis
each aim develops or defines the next
logical step in a process or mechanism
Connect the aims thematically
Possible models:
each aim presents a different approach or
perturbation to test a central hypothesis
each aim develops or defines the next
logical step in a process or mechanism
Specific Aim Guidelines, cont.
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Keep it simple
Clearly articulate the HYPOTHESIS
Avoid the over-ambitious label
Connect the aims thematically
Avoid contingent aims
Keep it simple
Clearly articulate the HYPOTHESIS
Avoid the over-ambitious label
Connect the aims thematically
Avoid contingent aims
Specific Aim Guidelines
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Avoid contingent aims
1 dependent aim couldbe a reasonablestrategy. More is usually a disaster.
requires compelling rationale (why Im
going out on a limb).
Requires an indication ofalternatestrategies (plan B)
Avoid contingent aims
1 dependent aim couldbe a reasonablestrategy. More is usually a disaster.
requires compelling rationale (why Im
going out on a limb).
Requires an indication ofalternatestrategies (plan B)
Specific Aim Guidelines, cont.
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Keep it simple
Clearly articulate the HYPOTHESIS
Avoid the over-ambitious label
Connect the aims thematically
Avoid contingent aims
Keep it simple
Keep it simple
Clearly articulate the HYPOTHESIS
Avoid the over-ambitious label
Connect the aims thematically
Avoid contingent aims
Keep it simple
Specific Aim Guidelines
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1. Effect of estrogenstructure onestrogen receptorconformation 1
2. Role of the ratio ofestrogen receptor
(ER) isoforms onconformation
3
4
2
3. Dependence of ER-
ligand conformationon recruitment ofcoregulators
(4. Future studies)
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Mechanisms of effects of T3 and HMG-CoAreductase inhibitors on cholesterol metabolism
Mechanisms of effects of T3 and HMG-CoAreductase inhibitors on cholesterol metabolism
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Specific AimsSpecific Aims
Research Design & MethodsResearch Design & Methods
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Convince the Reviewers that you have:
Sound plan to rigorously test the hypothesis
Skills, knowledge, and resources to
carry out the work
Considered potential problems and
pitfalls (and have a plan B)
Considered data interpretation and
conclusions
Convince the Reviewers that you have:
Sound plan to rigorously test the hypothesis
Skills, knowledge, and resources to
carry out the work
Considered potential problems and
pitfalls (and have a plan B)
Considered data interpretation and
conclusions
Research Design and Methods
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Possible Model:
Each section corresponds to a SA
(3 specific aims = 3 sections)
Reiterate Specific Aim
Re-statement of rationale
Study design
Methodology
Data analysis/interpretation
Possible Model:
Each section corresponds to a SA
(3 specific aims = 3 sections)
Reiterate Specific Aim
Re-statement of rationale
Study design
Methodology
Data analysis/interpretation
Research Design and Methods
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Re-statement of rationale
Brief~ of a page
Repeat the most compelling reasonsgiven in the introduction
Include rationale forselection of
animal model or
subject/population study groups
Re-statement of rationale
Brief~ of a page
Repeat the most compelling reasonsgiven in the introduction
Include rationale forselection of
animal model or
subject/population study groups
Research Design and Methods
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Study design
Clear, concise, and logical flow
Easy to follow fora reviewer who might not
be directly in the field
Forclinical studies: make sure the study
schedule is clear and the reviewer easily canfollow the procedure for each subject
If you lose reviewer here and they have to
reread numerous times, your score will suffer
Study design
Clear, concise, and logical flow
Easy to follow fora reviewer who might not
be directly in the field
Forclinical studies: make sure the study
schedule is clear and the reviewer easily canfollow the procedure for each subject
If you lose reviewer here and they have to
reread numerous times, your score will suffer
Research Design and Methods
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Methodology
Provide details formost important assays, procedures
Commercially available methods or kits need only tobe briefly described orreferenced
For methods crucial to your aims: give reviewers a
sense that this is well in hand. Reference published
work, abstracts, or numbers from work in progress.
Possible format: Lump all methodology into a
separate section at end
Methodology
Provide details formost important assays, procedures
Commercially available methods or kits need only tobe briefly described orreferenced
For methods crucial to your aims: give reviewers a
sense that this is well in hand. Reference published
work, abstracts, or numbers from work in progress.
Possible format: Lump all methodology into a
separate section at end
Research Design and Methods
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Data Analysis/Interpretation
Be Specific
Identify Potential Pitfalls/Problems
Data Analysis/Interpretation
Be Specific
Identify Potential Pitfalls/Problems
Research Design and Methods
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Data Analysis/Interpretation
Be Specific
Define the primary and secondary endpoints
Cite statistical tests to be used
What level of significance will be accepted?
What outcome is expected? List anticipated results
How will you interpret that outcome? What will youconclude?
What are possible alternate outcomes andinterpretations?
Data Analysis/Interpretation
Be Specific
Define the primary and secondary endpoints
Cite statistical tests to be used
What level of significance will be accepted?
What outcome is expected? List anticipated results
How will you interpret that outcome? What will youconclude?
What are possible alternate outcomes andinterpretations?
Research Design and Methods
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Data Analysis/Interpretation
Pitfalls and Problems
Address obvious potential technical difficulties
Be clear about plan B (and C)
Opportunity forpreemptive strike againstpotential criticisms
Dont go overboard
Data Analysis/Interpretation
Pitfalls and Problems
Address obvious potential technical difficulties
Be clear about plan B (and C)
Opportunity forpreemptive strike againstpotential criticisms
Dont go overboard
Research Design and Methods
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Convey to the Reviewer a sense
that you are on top of this:
Patient Enrollment
Statistics
Human Subjects Section
Convey to the Reviewer a sense
that you are on top of this:
Patient Enrollment
Statistics
Human Subjects Section
Clinical Research Applications
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PatientEnrollment
Inclusion and exclusion criteria
Potentially confounding variables
Specific plans for enrollment and collaborationwith clinicians
Estimates of availability and accessibility
Recruitment strategies
Likelihood of patient accrual
Experience: cite numbers from previous orpreliminary studies
PatientEnrollment
Inclusion and exclusion criteria
Potentially confounding variables
Specific plans for enrollment and collaborationwith clinicians
Estimates of availability and accessibility
Recruitment strategies
Likelihood of patient accrual
Experience: cite numbers from previous orpreliminary studies
Clinical Research Applications
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Statistics
Poorly presented or inadequate plans for
statistical analyses = major impact on scoreJustify sample size and provide power
calculations and analysis of 1 variable
Include strategy for adjustments for othervariables
Contact GCRC biostatistician for consultation
Statistics
Poorly presented or inadequate plans for
statistical analyses = major impact on scoreJustify sample size and provide power
calculations and analysis of 1 variable
Include strategy for adjustments for othervariables
Contact GCRC biostatistician for consultation
Clinical Research Applications
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Human Subjects Section
Incomplete information may affect
the scientific merit rating
NIH Advice to InvestigatorsSubmitting Clinical Research
Applications:http://cms.csr.nih.gov/ResourcesforApp
licants/AdvicetoInvestigatorsSubmittingClinicalResearchApplications.htm
Human Subjects Section
Incomplete information may affect
the scientific merit rating
NIH Advice to InvestigatorsSubmitting Clinical Research
Applications:http://cms.csr.nih.gov/ResourcesforApp
licants/AdvicetoInvestigatorsSubmittingClinicalResearchApplications.htm
Clinical Research Applications
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Good Luck !Good Luck !