Turgeon- July 31st

8/8/2019 Turgeon- July 31st

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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)


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



Specific Aim Guidelines


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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


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



Connect the aims thematically

Keep it simple






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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


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



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Keep it simple




Avoid contingent aims

Keep it simple







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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)


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)



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Keep it simple





Keep it simple

Keep it simple





Keep it simple



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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



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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


Study design

Methodology

Data analysis/interpretation



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Brief~ of a page

Repeat the most compelling reasonsgiven in the introduction

Include rationale forselection of

animal model or

subject/population study groups


Brief~ of a page

Repeat the most compelling reasonsgiven in the introduction

Include rationale forselection of

animal model or

subject/population study groups



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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



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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



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Data Analysis/Interpretation

Be Specific

Identify Potential Pitfalls/Problems


Be Specific

Identify Potential Pitfalls/Problems



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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?


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?



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Pitfalls and Problems

Address obvious potential technical difficulties

Be clear about plan B (and C)

Opportunity forpreemptive strike againstpotential criticisms

Dont go overboard


Pitfalls and Problems

Address obvious potential technical difficulties

Be clear about plan B (and C)

Opportunity forpreemptive strike againstpotential criticisms

Dont go overboard



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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


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



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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



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Incomplete information may affect

the scientific merit rating

NIH Advice to InvestigatorsSubmitting Clinical Research

Applications:http://cms.csr.nih.gov/ResourcesforApp

licants/AdvicetoInvestigatorsSubmittingClinicalResearchApplications.htm


Incomplete information may affect

the scientific merit rating

NIH Advice to InvestigatorsSubmitting Clinical Research

Applications:http://cms.csr.nih.gov/ResourcesforApp

licants/AdvicetoInvestigatorsSubmittingClinicalResearchApplications.htm



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Good Luck !Good Luck !

Turgeon- July 31st

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