NIH Mentored Career Development Awards K Series Part 3

1
NIH Mentored Career Development Awards (K
Series) Part 3

• Thomas Mitchell, MPH
• Department of Epidemiology Biostatistics
• University of California San Francisco

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Writing a competitive mentored K award grant
application

• 5 main sections of the grant application
• The Candidate
• Statements by Mentors, Co-Mentors, and
  Collaborators
• Description of Institutional Environment
• Institutional Commitment to Candidates Research
  Career Development
• Research Plan
• Specific Aims
• Background and Significance
• Preliminary Studies
• Research Design and Methods

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Research Plan

• Reviewers recognize that an individual with
  limited research experience is less likely to be
  able to prepare a research plan with the breadth
  and depth of that submitted by a more experienced
  investigator.
• Nevertheless, a fundamentally sound research plan
  must be provided.
• For candidates who require substantial didactic
  training as part of their program, the research
  plan may cover less than the full period of the
  award.

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Strategies that work Common mistakes to avoid

• Build a team Dont try to go it alone!
• Seek opportunities for collaboration.
• Identify collaborators to fill gaps in your
  expertise, especially a mentor or collaborator
  who is well known.
• Consider multidisciplinary approaches.
• Recruit senior colleagues who can provide advice
  and periodic peer-review of your grant
  application (e.g., overall scope, specific aims,
  methods)

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Strategies that work Common mistakes to avoid
(contd)

• 2. Find a good idea The idea must be creative,
  exciting, and worth funding.
• Concentrate ideas in your area of expertise that
  would make an impact on public health.
• Do your homework make sure your topic fills a
  gap in the existing literature.
• Pose interesting, testable hypotheses, whenever
  possible.
• Brainstorm potential topics with mentors and
  colleagues.

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Strategies that work Common mistakes to avoid
(contd)

• Keep in mind that your topic should fit the
  mission of the NIH, which is to increase our
  understanding of biologic processes, diseases,
  treatments, or prevention.
• Ideally, it should also match a funding priority
  of your NIH institute (e.g., NCI, NHLBI, NIAID).
• Just moving science forward is not enough so,
  tie your science to curing, treating, or
  preventing disease.
• You will be judged on the likelihood that your
  research can make an impact on public health.

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Strategies that work Common mistakes to avoid
(contd)

• 3. Less is more Dont bite off more than you can
  chew!
• An overly ambitious grant application can make
  reviewers question your ability to achieve your
  goals and also to wonder whether the project has
  been thoroughly thought through with your
  mentors.
• Many grant applications are not funded because
  they propose to do too much and are viewed as
  lacking focus.

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Strategies that work Common mistakes to avoid
(contd)

• For new investigators, reviewers will be more
  inclined to give you a fundable score if you bite
  off less work to do.
• Remember Focus, focus, focus

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Strategies that work Common mistakes to avoid
(contd)

• 4. Dont procrastinate Time is your greatest
  resource and your most important asset.
• Get started early (at least 4-6 months before
  grant application is due).
• Make steady progress arrange dedicated time each
  week for grant-writing.
• Get good peer review before you submit.
• Submit only your best work shoot for funding on
  the 1st round!

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Distinctive Features of a Research Plan for a
Mentored K award

• 3 key things to remember when designing a
  research plan for a K award.
• 1. The research plan is a training vehicle. The
  research plan should be well integrated with your
  career development training plan.
• 2. The research plan is a means to achieve
  independence. The research plan should be viewed
  as a precursor for a subsequent R01.

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Distinctive Features (contd)

• 3. Mentored K awards provide limited funding.
  The scope of the research plan needs to be
  appropriate and feasible, given the modest
  resources available in a mentored K award.
• A modular approach is possible, which might
  include several small projects, such as secondary
  analyses of existing data, leveraging ongoing
  cohort studies or clinical trials, or conducting
  a small pilot study.

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Specific Aims

• Suggested length 1 page
• Style Non-technical. Write this section for all
  study section members, since theyll all read it.
• Function After reading a well-written Specific
  Aims section, a reviewer should understand the
  following
• The long-term goals of the research and the
  specific problem being addressed in this
  research.
• The hypotheses being tested.
• The methodologic approach and feasibility of the
  project.
• The potential impact of the findings.

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Specific Aims (contd)

• Introductory paragraph(s)
• Begin by stating the general purpose or long-term
  goal of your research in terms of its relevance
  to the mission of the NIH (i.e., improving the
  diagnosis, treatment, and prevention of disease).
• The long-term goal should be broad enough to give
  the impression that this study is part of a
  larger research plan that will continue beyond
  the bounds defined in the Specific Aims.

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Specific Aims Introductory Paragraph(s), contd

• Clearly state the problem to be addressed
• Scope of the problem (describe importance of the
  problem, such as number of people affected,
  morbidity/mortality, costs to society).
• Nature of the problem (from a research
  perspective, what we dont know that we need to
  know in order to move forward provides rationale
  for specific aims).

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Specific Aims Introductory Paragraph(s), contd

• Describe your methodologic approach to the
  problem (e.g., randomized controlled trial,
  observational cohort, case-control study).
• Describe scope of project and its feasibility
  (e.g., availability of subjects, leveraging
  existing resources or infrastructure).

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Specific Aims

• Each aim should consist of one sentence be
  concise, concrete, and operational.
• Keep the number of aims to a minimum (2-4).
• Aims should be able to stand alone they can be
  related but must be independent (i.e., they do
  not depend on a particular outcome of a previous
  aim).
• State interesting, testable hypotheses, whenever
  possible.
• Include rationales, when needed.
• See Examples 1 and 2.

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Integration of research plan with career
development plan

• At the end of the Specific Aims section, describe
  how the research plan is integrated with the
  career development plan (give concrete examples).
• Each of these specific aims is designed to
  provide me with the necessary skills and
  experiences to become an independent health
  services researcher. My long-term goals are
  two-fold (1) to develop interventions to help
  clinicians better prescribe warfarin, and (2) to
  better describe risk factors for poor warfarin
  outcomes in an effort to improve existing risk
  stratification tools.

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Example (contd)

• In Aim 1, the research plan will provide
  experience in longitudinal data analysis,
  propensity score analysis, outcomes assessment,
  cost-benefit analysis, and pharmacoepidemiology.
  Aim 2 will provide experience in prospective data
  collection, development of an independent cohort,
  and assessment of patient functional status and
  frailty. Aim 3 will provide experience
  developing a decision support intervention and
  obtain pilot data for the subsequent intervention
  study.

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Example (contd)

• Additionally, each of these aims clearly
  comprises a necessary precursor for my
  anticipated R01 application. For example, Aims 1
  and 2 will provide crucial data on the risk
  factors, rates, and outcomes of
  warfarin-associated hemorrhage. Aim 3 will
  incorporate these data into a user-friendly
  decision tool that helps clinicians balance the
  risks and benefits of warfarin.

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Example (contd)

• Thus, this study will provide important pilot
  data in preparation for a larger practice-based
  intervention study investigating the effect of
  this decision tool on clinician prescribing of
  warfarin, patient understanding of the risks and
  benefits of warfarin, and on stroke and
  hemorrhage outcomes.

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Background and Significance

• In writing this section, keep in mind that you
  are writing for a general audience that is
  uninformed (about your topic) but intelligent,
  so you should write this section in non-technical
  language.
• Suggested length 3 pages

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Significance

• After reading the aims and hypotheses, the
  reviewer should have a pretty clear picture of
  what you plan to do.
• Now, they want to know why you want to accomplish
  these aims.
• This is where many applications fall flat.
• They fail to make a compelling case for their
  research project, leaving reviewers with no
  answer to the big question SO WHAT?

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Significance(contd)

• Describe the significance of your research at the
  beginning of the Background and Significance
  section. Do not be subtle deliver your message
  fast.
• State the importance of the problem.
• If the aims of the application are achieved, how
  will scientific knowledge or clinical practice be
  advanced?
• What will be the effect of these studies on the
  concepts, methods, technologies, treatments,
  services, or preventative interventions that
  drive this field?

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Significance(contd)

• Emphasize what is innovative about your research.
• Examples Challenging existing paradigms, testing
  novel hypotheses, using newly developed
  state-of-the-art measurements.
• Discuss the potential impact of your research
  relate your anticipated results to the
  longer-term, big picture scientific objectives
  and to the betterment of health.
• See Example 3.

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Background

• This section is one of the main ways together
  with the significance section that you justify
  the need for the proposed research.
• Dont write a comprehensive review of all of the
  literature on your topic.
• Identify gaps in the literature that are relevant
  to your research topic, and always indicate how
  your specific aims will address these gaps.
• Remember to cite the literature that supports
  your hypotheses.
• Identify the next logical stage of research
  beyond your current application.

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Background(contd)

• Writing tip
• Use bolded subheadings that convey the main point
  of each section (i.e., a topic sentence
  subheading rather than just a topic
  subheading). For example
• Topic subheading HIV infection and
  atherosclerosis.
• Topic sentence subheading Patients with HIV
  infection develop premature or accelerated
  atherosclerosis.

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Background(contd)

• Thus, by reading only the bolded topic sentence
  subheadings, reviewers can understand the basic
  argument you are trying to make.
• They also make it easier to write a short, cogent
  background section.
• See Examples 4 and 5.