Christopher Vinnard, MD MPH MSCE
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Intramural
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 PEG grants
 Burroughs Wellcome
 CTRI
 Doris Duke Charitable
Foundation
 Gates Foundation
 PhRMA Foundation
 Coulter awards
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Professional Societies
 Geography
 Discipline
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Foundations
Big Pharma
 Investigator initiated
proposals
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AHRQ
DoD
NIH
 F32, K23, R03, R21
MDs
Vs
PhDs
Emphasize your clinical training and experience
Finesse the argument that the central problem/question
of your grant is clinically important but overlooked
 Impress your reviewers with your access to the targeted
patient population
 Build interdisciplinary collaborations but keep your
involvement/expertise at the center
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Sketch out your research project (specific aims,
hypothesis, approach
 Contact the potential funding source before you start
writing the grant
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 NIH: Contact a program officer for your institute to discuss
 Foundations: Contact the Drexel Foundations and Corporate
Relations office for detailed help
Build the research team, filling gaps in scientific
expertise
 Write the grant
 Circulate for feedback/comments 1-2 months before
submission deadline
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NIH mission: To create
fundamental knowledge about
living systems and apply that
knowledge to reduce human
illness and disability
27 institutes and centers, each
with its own research focus or
function
grants1.nih.gov/grants/grant_tips.htm
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A searchable database of federally supported
biomedical research
Access reports, data, analyses, expenditures,
results of NIH supported research activities
Identify, analyze IC research portfolios, funding
patterns, funded investigators:
• Identify areas with many or few funded projects
• Identify NIH-funded investigators and their research
• Identify potential mentors/collaborators
http://report.nih.gov/
 Specific Aims
 Significance
 +/- Innovation
 Preliminary Data
 Approach
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Grants are considered “intellectual property”,
so ask with care and caution
Investigators lower in the food chain may be
more open about sharing proposals
Guarantee to the PI that it will not be shared
elsewhere
Look for both successful and unsuccessful
applications
 If unsuccessful, get the critique if available
http://www.niaid.ni
h.gov/researchfundi
ng/grant/pages/app
samples.aspx
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Imagine you had a 2
minute elevator ride with
Bill Gates, Frances Collins,
or Dr. Simansky
 How would you introduce
the problem?
 What is your hypothesis?
 How could the question be
answered?
 What would come next?
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Assume that the reviewer has a background
in the scientific method, but not necessarily
expertise in your particular field
Literature review = Fail
Tell a compelling story that arrives at a
particular clinical question
Leave the reader amazed that no one yet
knows the answer to that particular question
Propose a hypothesis that reflects a novel
explanation or mechanism
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Early career clinical investigators often don’t
have a wealth of preliminary data to draw from
You must demonstrate feasibility of the
proposed study and plausibility of the proposed
relationship
Usually expected by reviewers even if the grant
announcement states otherwise
Possible solutions:
 Ask to share data generated by your collaborators
 Interpret “pilot data” very loosely
 Ask your Chair if some minimal funding is needed
($1,000-5,000, perhaps)
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Intervention or system to be studied
Target population
Inclusion and exclusion criteria
Independent and dependent variables
All measures and instruments
Power or sample size analyses
 Power when you have a fixed population of a
known size
 Sample size for all other situations
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Review your work from the
“why?” perspective
Answer the reviewer’s
questions before they can
think of them
Every decision in your
approach must be defended
and explained
Offer prior data or biologic
plausibility in support of
your decisions
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Your reviewers may or may not have a statistical
background
Even when they do not, often they will believe that
they do
Balance mathematical accuracy with readability
Don’t get too novel with your statistical methods
(stay with the tried and true approaches)
When you meet with your statistician, you will need
to tell them what effect size would be clinically
important
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No reviewer wants to fund a dead end project
What comes next if you reject the null
hypothesis?
What comes next if you fail to reject the null
hypothesis?
For smaller awards, what is the next funding
source you will apply for?
What is the 10-year timeline for work in this
area?
How would your work eventually transform
clinical care?
Study Section decides your fate
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Members with conflicts excused
Initial levels of enthusiasm stated (assigned reviewers)
Primary reviewer - explains project, strengths,
weaknesses
Other assigned reviewers and discussants follow
Open discussion (full panel)
Levels of enthusiasm re-stated (assigned reviewers)
Chair summarizes main points from discussion
All Study Section members vote – private ballot
Other review considerations discussed (budget)
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SIGNIFICANCE
 Does this study address an important
problem?
 If the aims are achieved, how will
scientific knowledge be advanced?
 What will be the effect on concepts or
methods that drive this field?
INVESTIGATOR
 Are the investigators appropriately trained
and well suited to carry out this work?
 Is the work proposed appropriate to the
experience level of the principal investigator
and other researchers?
 Does the investigative team bring
complementary and integrated expertise to
the project (if applicable)?
INNOVATION
 Does the project employ novel concepts,
approaches or methods?
 Are the aims original and innovative?
 Does the project challenge existing
paradigms or develop new methodologies
or technologies?
APPROACH
 Are the conceptual framework, design,
methods, and analyses adequately
developed, well-integrated, and
appropriate to the aims of the project?
 Does the applicant acknowledge potential
problem areas and consider alternatives?
ENVIRONMENT
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Does the scientific environment in which the
work will be done contribute to the probability
of success?
Do the proposed experiments take advantage of
unique features of the scientific environment or
employ useful collaborative arrangements?
Is there evidence of institutional support?
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Lack of innovation or new ideas
Lack of a strong, original hypothesis and
Specific Aims
Needed to identify potential pitfalls and
alternative approaches
Concern about knowledge of the field (didn’t
cite relevant papers or account for alternative
viewpoints)
Peer Review group not a good match
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Poorly formatted, typographical errors,
grammatical errors, lack of proofreading, or
unappealing presentation
Insufficient preliminary data, or preliminary
data do not support project's feasibility
Overly ambitious
Lack of significance to the field or public
health
Lack of investigator expertise or team
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Up to $35k/year in
educational loan repayment
 Depending on debt level
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Coverage of most Federal
taxes resulting from the NIH
LRP
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2 year initial contracts
 1 or 2 year competitive
renewal
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50% application success rate
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Citizenship: U.S. citizen, U.S. national or permanent resident
Doctoral degree: health professional degree (M.D., Ph.D. or
equivalent)
▪ EXCEPTION = Contraception & Infertility Research LRP
Qualified educational debt: Educational loan debt = or >20%
of your annual salary
Domestic, non-profit research funding: including university or
government organization
Qualified research: must be conducted = or >20 hours/week
(50% effort)
Purpose:
Recruit and retain highly qualified health professionals as
clinical investigators.
Qualifying research:
 Must have direct interaction with patients
 Patient-oriented clinical research
 Research on the causes and consequences of disease
 Clarify a problem in human physiology, pathophysiology
or disease,
 Epidemiologic or behavioral studies
 Outcomes research or health services research
 Develop new technologies, therapeutic interventions, or
clinical trials
September 1 –
November 15:
Application Cycle
November 15:
Application
Deadline
December 1:
Colleague Deadline
December 31:
Contract and Online
Certification &
Citizenship Forms
Deadline
February – May:
Application Peer
Review
May: Initial
Selection
May – July: Financial
Vetting
July 1: Contract
Start Date
Mid-July: Final
Funding Decisions
and Recipient
Notification
August –
September:
Contract Signing
October: First
Payment to Lender
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Don’t be shy ab0ut asking for
things
Get commitments in writing
Hold people accountable to
their commitments
Do as much work for your
collaborators as you can
If someone is not responding to
initial queries, look elsewhere
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IDSA Young Investigator Award- FAIL
PhRMA Foundation- FAIL
Burroughs Wellcome Foundation- FAIL
First NIH K23 submission - FAIL
Travel Medicine Society grant- FAIL
CURE grant- FAIL
PEG grant- FAIL
WW Smith Foundation- FAIL
Landenberger Foundation – FAIL
Searles Scholar Program- FAIL
Doris Duke Foundation Clinical Investigator- FAIL
Second NIH K23 submission- FAIL
Bill & Melinda Gates Foundation – SUCCESS
Clinical and Translational Pilot Research Program- SUCCESS
Janssen L.L.C. investigator initiated award- SUCCESS
Second NIH K23 resubmission- SUCCESS
Risk + Effort + Time = …
christopher.vinnard@drexelmed.edu