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Writing Specific Aims: The Cornerstone of a Successful Research Proposal Writing Specific Aims: The Cornerstone of a Successful Research Proposal

Writing Specific Aims: The Cornerstone of a Successful Research Proposal - PowerPoint Presentation

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Writing Specific Aims: The Cornerstone of a Successful Research Proposal - PPT Presentation

COL Kent Kester Associate Dean for Clinical Research USU School of Medicine 23 May 2013 What you should learn from this session The importance and centrality of the Specific Aims section of a research proposal ID: 708456

specific research proposal aims research specific aims proposal nih knowledge hiv project grant clinical hypothesis impact malaria important disease

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Slide1

Writing Specific Aims:The Cornerstone of a Successful Research Proposal

COL Kent KesterAssociate Dean for Clinical ResearchUSU School of Medicine

23 May 2013Slide2

What you should learn from this session

The importance and centrality of the Specific Aims section of a research proposalHow the Specific Aims section fits in to the larger research proposal and its developmentTo see some examples of successful Specific Aims submitted as part of research grant proposalsSlide3

Getting Research Grants Funded

Good ScienceHypothesisApproachGood MarketingWell-written proposal responsive to the program instructions

SALES!!!Slide4

Steps associated with the NIH grant application process

Berg, KM, et al. J Gen Int Med 2007;22:1587-95Slide5

Grant-writing timeline

Inouye, SK, et al. Ann Intern Med

2005;142:274-282Slide6

Grant-Execution Timeline

Inouye, SK, et al. Ann Intern Med 2005;142:274-282Slide7

Common Reasons for unfunded proposals

Lack of new ideasUnfocused research plan: poorly-written or unresponsive to program directionsLack on knowledge of published relevant workLack of essential scientific experienceFuture directions of research?

Questionable experimental approach

Unrealistic scope of work

Lack of experimental detail

Limited funding: major issue at present

FY13: NIAID R01 new investigator

12%

; established investigator

8%Slide8

Define your goals

SpecificMeasurableRealisticSlide9

Specific Aims:The

Cornerstone of the entire research proposal What do you want to accomplish (objectives)?This is the master plan for your research.

Not unusual for some members of the study section to read only the Specific Aims and Project Summary/Abstract before scoring.

Dense, full-of-jargon, poorly-written Specific Aims will not help the scoring of your proposal, even if the science is sound!

Is a useful summary for obtaining early feedback on your proposal

Includes project milestones, hypotheses to be tested—all the key aspects of your project (e.g.,

what is important and exciting

) without fine detail

Aim for an unmet scientific need

Be crystal-clear in your writing!

You provide the conceptual framework upon which the reviewers hang the details of what will be done.Slide10

Funding Sources

NIH/AHRQR01 Research Project GrantR03 Small Grant ProgramR15 Academic Research Enhancement AwardR21 Exploratory Research Grant

U01 Research Project Cooperative Agreement

K99/R00 Pathway to Independence Award

Other Federal Sources

DoD: MRMC, DHP, MILVAX, DTRA, DARPA

Infectious Disease, Combat

Casualty

Care, Military Operational Medicine, Regenerative Medicine, etc.

CDC

DVA

Others: USDA, USAID, FDA, etc.

Foundations/Nonprofits

Gates Foundation

Disease-specific foundations

Industry

Research or clinical trials support

CRADAs, grants, or in-kind funding

In many cases, the standard NIH format for organization of your grant proposal is often preferred.

Read the submission instructions!Slide11

Specific Aims: Often the Hardest Part of the Proposal to Write

The most important part of your proposal—you have to “SELL” your research idea!Understand your customer (e.g., Study Section reviewers)Show that you will help NIH (or DoD, DVA, etc.) accomplish its goalsStart with a concise problem statement and state why it is importantLimit yourself to 2-4 aims

Be declarative

Make sure to explain why the research matters

Final product: A well-crafted project that will result in the advancement of significant knowledge in your fieldSlide12

Know Your Audience

Align your project with defined research prioritiesParticularly relevant to DoD-funded medical research (e.g., what is really important to the DoD?)Identify who will be reviewing your proposalhttp://public.csr.nih.gov/StudySections/Pages/default.aspxKnow the evaluation criteria

NIH: significance, investigator, innovation, approach, environment

Others:

Find Out

if not specified (= do your homework!)Slide13

First Impressions of Your Proposal

TitleAbstract: the movie posterSpecific Aims: the movie trailerSlide14

Themes for Specific Aims

Convince the reviewers that the funding will be a good return on investment (SALES)Write for a general science audience; don’t bury your aims in too much jargonExplain specialized terminologyToo dense to read = too dense to fundKeep it general and interestingFocus on Why, Who, What, and HowSlide15

NIH Research Project Grant Review Criteria

Significance: is the work important?Innovation: is it new thinking?Approach: is it feasible?Investigator(s): are they well-suited?Environment: is there adequate support and resources?Slide16
Slide17
Slide18

It is essential to start with a good question.

What is the mechanism of X?Is this drug/vaccine/diagnostic device better than the current standard?Does this new curriculum result in enhanced learning?Does this change in clinical practice improve clinical outcomes?Slide19

The best research questions have significance and impact.

Does the project address an important problem (knowledge gap)?Novel antiviral drug: new mechanism of actionIdentification of previously-unrecognized pathway for viral or parasite development in insect vectors prior to transmission to humansIf the goals of the project are achieved

How will scientific knowledge or clinical practice be improved?

How will the field be changed?Slide20

Proposal should be based on a hypothesis

Hypothesis: a general statement, based on existing information, that describes a process in natureAllows one to make specific predictions that can be tested experimentallyProperties:Fit: compatible with existing knowledgeTestabilitySimplicity

Generality: applies broadlySlide21

Elements of a Specific Aims Page

Concise statement of the goals of the proposed research and a summary of the expected outcomes, including impact on the fieldList the specific objectives of the research:

Test a hypothesis

Create a novel design

Solve a specific problem

Challenge an existing paradigm or clinical practice

Address a critical barrier to progress in the field

Develop new technologySlide22

A good format for a Specific Aims Section is a sandwich

First section: topic, goals, objectives, hypothesis, and rationaleSpecific Aims: objectives and descriptionHEADLINESLast paragraph: impact and outcomesConsider use of visual models in order to communicate a complex subject.Slide23

Writing Specific Aims

Create a bullet outlineConsider organizing bullets within four distinct paragraphs:Introductory paragraphWhat, Why, Who paragraphSpecific Aims paragraphPayoff paragraph: helps to develop advocacy for your proposal among the majority of reviewers who will not, in all likelihood, have read the complete application

There should be at least one important expected outcome for each of your aims.Slide24

First paragraph: provides the rationale for the proposed study(ies)

What is the Topic?Opening sentence needs to be interest-grabbing.Statement of current knowledge: will help less-expert panel members get up to speed with respect to what is know about the topic of the applicationWhat is the Gap in knowledge?

The gap in knowledge is what is holding back the field and is what you will address in the application.

What is the long-term Goal of your research?

What are the specific Objectives for the proposal?

What is the Hypothesis?

What is the evidence for the hypothesis?

What is the Rationale/Significance?

GOAL

: half-page or less (~300 words) to set the stage and to interest the reviewerSlide25

Start the Specific Aims with a concise, active statement introducing the topic of the proposal

In sub-Saharan Africa, co-infection with HIV worsens clinical malaria and has resulted in an additional 3 million cases of clinical malaria and 65,000 deaths.Diabetes is a major health concern in the U.S.Molecular analysis has emerged as one of the most powerful tools to determine antimicrobial resistance mechanismsSlide26

Describe the gap in knowledge or unmet need that the proposal will address

There is a critical gap in our knowledge about the impact of HIV on asymptomatic malaria and how HIV may impact the ability of adults to serve as efficient reservoirs of disease.But the incidence of diabetes continues to rise.Management of parasitic diseases depends largely on chemotherapy but anti-parasitic drug treatments has multiple challenges.Slide27

Describe your goals

Our long-term goal is to understand how behavioral modification can prevent the early onset of diabetes.The goal of our research is to determine the mechanism of X (or Y, or Z).The overall goal of our research group is to define the role of …Slide28

Describe the specific objectives

We propose to focus a series of complementary clinical and entomological studies using highly sensitive and specific molecular tools in a highly endemic area of western Kenya to address…This proposal will focus on testing behavioral interventions in the institutionalized elderly.We propose to develop artificial intelligence algorithms for the analysis of thought-related changes in cerebral perfusion.Slide29

Define the underlying hypothesis

We hypothesize that HIV itself, and the treatment used routinely for opportunistic infection prophylaxis, contribute to excess malaria burden by increasing the prevalence of asymptomatic adult reservoirs that experience frequent and prolonged periods of transmissible sub-microscopic gametocytema.Both of these responses are unique to a subset of enterococci exhibiting the Van-A phenotype, and we hypothesize that they are essential for the pathogenesis of…Slide30

Describe the evidence for the hypothesis

For the first time, our published data from macaques support a direct enhancing effect of retrovirus pre-infection on malaria parasite growth, gametocytogenesis, and transmission.Prior studies conducted by our group have demonstrated novel interactions between unbound phenytoin and coronary endothelial cells.Slide31

Each specific aim has a short descriptive title and brief description

Aim 1: To determine the pathogenesis of the disease in vivoBased on our hypothesis, we predict that disruption of the interaction between XYZ and the ABC receptor will increase resistance to the diseaseAssess disease pathogenesis in mice with mutations in XYZ or the ABC receptorAssess disease resistance in mice treated with siRNA directed toward XYZ or the ABC receptorSlide32

Specific Aim Examples

Aim 1: Point prevalence of co-infectionWe will determine whether the prevalence and magnitude of peripheral parasitemia, and specifically gametocytemia, are greater in untreated HIV-positive adults than in HIV-negative adults. These data will reveal whether untreated HIV-infected persons are, in fact, more efficient reservoirs of malaria.Aim 2: Longitudinal prevalence of asymptomatic parasitemiaWe will compare the incidence, intensity, and duration of asymptomatic malaria parasitemia in general, and gametocytemia specifically, in HIV-negative adults, in HIV-positive adults on TS only, and in HIV-positive adults on TS plus ART. We will measure the impact of prolonged TS therapy on gametocyte carriage.Slide33

The last paragraph focuses on innovation, impact, and outcomes

Innovation: To our knowledge, this proposal is the first attempt to use microarray technology to discern differential patterns in human gene activation associated with experimental malaria infectionThis proposal applies two state-of-the-art techniques to understand the pathogenesis of sarcoidosis.Note that innovation doesn’t always mean the use of the latest molecular biology tools and techniques.

Outcomes and Impact:

The experiments described in this proposal will provide a complete description of the mechanism…

Understanding the pathogenesis of this disease will lead to new therapeutic approaches.Slide34

Additional Details

Make sure that research proposal is properly aligned with the funding program (= read the directions)Get feedback!Make sure that there are no stray regulatory compliance issues (like human subjects or animal welfare). Ignoring these aspects can doom your proposal.Slide35
Slide36

http://projectreporter.nih.gov/reporter.cfmSlide37

Some final thoughts

Lay out your aims so clearly so that the reviewers understand them without having to read things more than once.Lead the reviewer down a logical trail of ideas that makes the conclusion of what is being proposed to be done is inescapable. One can include a relevant quotation from the NIH Director or an excerpt from an NIH strategic research plan).Pique the reviewer’s interest—help them share your sense that there is an important mystery to be solved.Slide38

And remember…

No amount of flowery language will overcome a skeptical audience.Propose good scienceWrite wellFollow the directionsGet feedbackSlide39

References

Inouye SK, Fiellin DA. An evidence-based guide to writing grant proposals for clinical research. Annals of Internal Medicine 2005;142:274-282.Berg KM, Gill TM, Brown AF, et al. Demystifying the NIH grant application process. Journal of General Internal Medicine 2007;22(11):1587-1595.