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Proposal Writing 2: Preparing an Application for Career Development or New Investigator Awards
Shehnaz K. HussainAssistant ProfessorDepartment of Epidemiology, [email protected]
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Outline and Objectives
Part I: Intro to Career Development Awards (CDAs) and New Investigator Awards
What are they? Who applies for them? Which agencies have them? What are the most important components of the application?
Part II: Focused Discussion of the Research Plan
study design, statistical analysis and power, problems and pitfalls
Part II: Practical demonstration of sample size and power calculation
E, G, E*G
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Part I: Description of CDAs and New Investigator Awards
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Career Development Awards: What are they?
Awards for individuals with doctoral degrees who demonstrate need for additional training
Up to 5 years of support for salary (up to $100,000/yr)
research ($30-75,000/yr)
Multiple interconnected elements
Intent is to prepare investigator for R01-type grant submission
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Career Development Awards: NIH K series (1)
Types of awards:K01: Mentored Research Scientist DevelopmentKO7: Mentored Research Career DevelopmentK08: Mentored Clinical Scientist DevelopmentK12: Mentored Clinical Scientist DevelopmentK23: Mentored Patient-Oriented Research Dev. K25: Mentored Quantitative Research DevelopmentK99/R00: NIH Pathway to Independence Award
http://grants.nih.gov/training/careerdevelopmentawards.htm
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Career Development Awards: NIH K series (2)
Which K award is right for you?Terminal doctoral degreeYears of mentored support requiredSpecific research area
http://grants.nih.gov/training/kwizard/index.htmhttp://grants.nih.gov/grants/guide/search_guide.htm
What types of awards does NCI fund?
http://crisp.cit.nih.gov/http://fundedresearch.cancer.gov/search/SearchForm
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Career Development Awards: NIH K series (3)
Pre-doc Post-doc Jr. Faculty Independent
Mentored
T32
T90/R00
R25
F31
T32
T90/R00
R25
K12
F32
K07
K22
R25
K08
K01
K07 K08
R01
K22
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0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007Fiscal Year
Num
ber o
f Aw
ards
Data provided by the Division of Information Services, Reporting Branch
Trends in Number of Funded Research Career Awards
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0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
KL1KL2K99K17K15K20K26K11K06K25K04K16K14K18K22K30K12K05K07K24K02K23K01K08
Fiscal Year
Num
ber o
f A
war
dsTrends in Number of Funded Research Career Awards By Type
Data provided by the Division of Information Services, Reporting Branch
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Participating NIH Institutes and Centers
K07 Applications and Awards by Participating Institutes: FY 2007N
umbe
r of A
pplic
atio
ns/A
war
ds Applications Awards
Data provided by the Division of Information Services, Reporting Branch
0
10
20
30
40
50
60
70
NCI NIA NHLBI NCCAM
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Career Development Awards: Other mechanisms for support
Susan G. Komen Foundation: Career Catalyst Awardshttp://ww5.komen.org/researchgrants/grantprograms.html
American Cancer Society: Mentored Research Scholar Grantshttp://www.cancer.org/docroot/RES/RES_5_1.asp
Others: American Lung AssociationAmerican Heart AssociationCenters for Disease Control and Prevention
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Career Development Awards: 4 main parts to an NIH K-award app
1. Candidate statement2. Mentor letters3. Environment and institutional commitment to the candidate4. Research plan
3 sealed letters of recommendation, abstract, budget (modular) and justification, resources, biosketches, other support
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1. Candidate Statement
Candidate’s backgroundMake a compelling argument why you need a K award Be specific: give concrete examples of areas where you need additional training/experience in order to conduct the proposed research or meet research career goalsConvince reviewers that you are an outstanding candidate; include evidence of productivity (e.g. publications, presentations)
Career goals and objectivesshort- and long-term career goals
Career development planuniquely suited to youPropose a mix of didactic training (specific courses, individualized tutorials , etc.) and “hands on” research experienceThe research plan should include some specific “challenges,” for which you need additional training and experience to accomplishThese “deficits” are the focus of your career development plan
Training in the Responsible Conduct of Research
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2. Mentors Letters
Candidate’s description of mentorsPrimary area of researchMentoring track recordRelevance of mentor’s research to proposed training and/or researchMentor’s role in proposed training/researchInclude an evaluation component that describes how your mentors will assess your progress (e.g., quarterly meetings)
Primary mentor’s letterSenior investigator with a track-record of NIH funding Describes how the mentoring team will work togetherHis or her qualifications in the research proposed by the candidatePrevious experience as a research supervisorThe nature and extent of supervision that will occur
Co-mentors’ lettersA team of 2-3 additional mentors with complementary strengths, counter-balance any weaknesses Letters are shorter, but must be consistent with text in grant application (re: frequency of meetings, etc.).
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3. Environment and Institutional Commitment to the Candidate
Description of the institutional environmentResearch facilitiesEducational opportunities and relevance to career development plan
Institutional commitment: department chair’s letter
Confirm full-time faculty position during the K award period Protect at least 75% of effort for proposed research and career development activities
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New Investigator Awards: What are they?
Small amount of money ($30-100,000/yr) for risky, innovative, research with limited or no pilot data
New faculty (<5 years)
The intent is to help an investigator gather preliminary data necessary to pursue more developed studies (RO1-type grant application)
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New Investigator Awards: Mechanisms for support
UCLA JCCC: Seed Grantshttp://www.cancer.ucla.edu/index.aspx?page=165
UCLA AIDS Institute: Seed Grantshttp://www.uclaaidsinstitute.org/apply/apply.php
CHRP and CBCRP: IDEA Awardshttp://chrp.ucop.edu/applicants/appl_award_types.htmlhttp://www.cbcrp.org/apply/
DoD Congressionally Directed Medical Research Programs: Concept Awardshttp://cdmrp.army.mil/funding/default.htm
NIH: R-series (R21, R03, even RO1)http://grants.nih.gov/grants/new_investigators/index.htm
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New Investigator Award: 3 main parts to a CHRP IDEA app
1. New investigator justification
2. Responsive statement
3. Research plan*
Letter of Intent, Abstract (lay and scientific), budget and justification, resources, biosketches, other support
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Part II: Research Plan
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Research Plan: Required components
A. Specific Aims and Hypotheses
B. Background
C. Preliminary Studies
D. Research Design and Methods
E. References
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Research Plan: Additional requirements for NIH grants
F. Protection of Human Subjects
G. Inclusion of Women and Minorities
H. Targeted/Planned Enrollment Table
I. Inclusion of Children
J. Vertebrate Animals
K. Select Agents
L. Consortium/Contractual Arrangements
M. Letters of Support
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Research Plan: Required components
A. Specific Aims and Hypotheses
B. Background
C. Preliminary Studies
D. Research Design and Methods
E. References
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RESEARCH DESIGN & METHODS
Addressing:
SPECIFIC AIMS
Supported by:
BACKGROUND & SIGNIFICANCE
PRELIMINARY STUDIES
Yang, Otto O. Guide to effective grant writing : how to write a successful NIH grant application
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Research Plan: Effort preparing versus reviewing
PREPARE REVIEWSpecific Aims 1% 9%Background 75% 1%Preliminary studies 9% 10%Research Design and Methods
15% 80%
Borrowed from Dr. Louise C Strong, U.T. M.D. Anderson Cancer Center
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Specific Aims
Focus, limit number of aims to 2-3Short and self-contained summary of the research questions and project goals Stand aloneThe success of one aim should not be dependent on the success of others
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Background
Provide a context for your work, make the case for why this research is important
Thorough but concise, include only pertinent information
End with a summary of current state of knowledge, what remains to be done, and highlight the innovation and significance of the proposed research
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Preliminary Studies
New investigators not expected to have a very elaborate preliminary studies section
A combination of your mentors’ research and your own experiences
Purpose: support the hypothesis
demonstrate previous experiences conducting similar research
showcase qualification of PI and mentors
Summarize importance at the end
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Research Design and Methods: Overview
A blueprint for the work to be performed
Due to limited funding, scope of the research plan needs to be appropriate
Piggy back project on mentor’s R01
For CDAs, the research plan is a training vehicle and should be well integrated with career development training plan
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Research Design and Methods: Methods details
Study designStudy populationDescription of specimens SNP Discovery/selectionLab methodsStatistical analysis Statistical powerTimelinePotential results and interpretationStrengths and limitations of approach
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Research Design and Methods: Common limitations
Multiple comparisons Can use a post-estimation false discovery adjustmentCan use an alpha less than 0.05 for power calculations
Sample size Power calculationsPropose follow-up studies
Population stratificationSubgroup analysesChoice of study designmatching on raceadjust for ancestral informative markers
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Part III: Statistical Power
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False positive: Conclude that there is an association between E and D when there is not
α = Pr (Type I error) = level of statistical significance
False negative: Conclude that E and D are not associated when they truly are
β = Pr (Type II error)
Statistical power = 1 – β The probability that the null hypothesis will be rejected if it is indeed false
Statistical Power: Types of error
DECISION TRUTH
Ho is True Ho is False
Do not reject Ho Correct Type II error
Reject Ho Type I error Correct
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Statistical Power: Determinants
Sample size, exposure frequency, Type I error rate
Genetic model
Linkage disequilibrium
Genotyping error
Study design
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0.10 0.20 0.30 0.40 0.50
Minor allele frequencies
Recessive
1.0 1.5 2.0 2.50.0
0.2
0.4
0.6
0.8
1.0
Effect Size
Pow
er
Log-additive
1.0 1.5 2.0 2.50.0
0.2
0.4
0.6
0.8
1.0
Effect Size
Pow
er
300 cases, 300 controls, alpha=0.05
Statistical Power: Effects of genetic model and allele freq
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0.10 0.20 0.30 0.40 0.50
Minor allele frequencies
Recessive
1.0 1.5 2.0 2.50.0
0.2
0.4
0.6
0.8
1.0
Effect Size
Pow
er
Log-additive
1.0 1.5 2.0 2.50.0
0.2
0.4
0.6
0.8
1.0
Effect Size
Pow
er
300 cases, 300 controls, alpha=0.05
Statistical Power: Effects of genetic model and allele freq
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SNPs genotyped
SNPs not genotyped r2 Sample size requirement
S1 and S2 - - 600 600
S1 S2 1.00 600 600
S1 S2 0.85 600 706
N/r2 (Pritchard, 2001)
S1 S2
Statistical Model: Effects of linkage disequilibrium
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Statistical power: Effects of genotype error
Generally non-differential Reduces your power
Every 1% increase in genotyping error rates requires sample size increased by 2-8% (Zou et al, 2004, Genetic Epidemiology)
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Statistical Power: How to calculate
Calculate sample size for a given power and alpha, or power for a given sample size and alphaAlternative: minimum detectable OR for a given power, sample size, and alphaCalculators:
QuantoHtpowercc
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Quanto
http://hydra.usc.edu/GxE/Study design
Case-control (Matched or Unmatched)Case-onlyCase-siblingCase-parent trios Independent sample of individuals for quantitative traits
Genetic and environmental main effectsInteractions
Gene-geneGene-environment
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Table D.2. Minimum detectable odds ratios for a given allele/haplotype frequency (Po) & mode of inheritance (additive, dominant, and recessive)
All NHL N=220 ca/660 co
Non-CNS NHL N=154 ca/462 co
Non-CNS NHL, MACS only N=130 ca/390 co Po
Add Dom Rec Add Dom Rec Add Dom Rec 10% 1.59 1.67 >3.0 1.72 1.83 >3.0 1.80 1.92 >3.0 20% 1.44 1.56 2.42 1.54 1.69 2.78 1.59 1.77 2.98 30% 1.38 1.56 1.93 1.47 1.70 2.16 1.52 1.79 2.28 40% 1.36 1.61 1.72 1.45 1.78 1.89 1.50 1.88 1.98 50% 1.36 1.74 1.61 1.45 1.96 1.76 1.50 2.10 1.84
Table D.4. Minimum detectable interaction odds ratios for a given main effect, allele/haplotype frequency (Po) & mode of inheritance (additive, dominant, and recessive)
All NHL N=220 ca/660 co
Po Add Dom Rec
20% 1.71 2.27 >3.0
40% 1.55 2.90 >3.0