1. BU Career Development Grant Writing Course- Session 3, Approach

2. Initial Thoughts
Of all the review criteria, approach most closely correlates with overall impact score
Experiments/studies designed to test each aim
Include enough detail to convince Reviewers that you understand and can handle a method
Mentorship is important here
Think “less is best”– propose a clearly defined problem, with each Aim addressing part of that problem. This is clear and not “overly ambitious”

3. 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 R.
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.

4. Approach: General
Describe the overall strategy, methodology, and analyses to be used to accomplish each specific aim. Include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate.
Describe any strategy to establish feasibility, and strategy to manage any high risk aspects of the work.
A discussion of possible problems and how they will be managed, alternative approaches that might be tried if the initial approaches do not work, and benchmarks for success

5. Approach Aim I Statement of hypothesis
Rationale that supports hypothesis
Literature
Impact
Preliminary data/feasibility
Experimental design
Expected outcomes and statistical analysis
Pitfalls and alternative plans
Aim II
Timetable

6. 11. Research Strategy Significance Innovation Approach
Preliminary studies
Research Design & Methods
Data Analysis
Challenges & Solutions
Timeline
Often organized by aim

7. Preliminary Studies
Make it clear what you do well and what unique skills you and your team bring to the research
Show how your previous experience prepared you for the project
Feasibility
Informs power/sample size calculations
Interpret your preliminary results critically
Make clear which data are yours & which are not

8. Research Design & Methods
Data sources
Study population
Data collection
Recruitment, sampling strategy
Inclusion/exclusion criteria
Enrollment & attrition if secondary analysis
Procedures:
Interviewer-administered questionnaire
Focus groups
Semi-structured interviews
Medical records
Neighborhood canvassing
Randomization

9. Analysis Plan
Measures
Statistical analysis
Power calculations

10. Measures Must mirror what is in the aims
Conceptual framework
New, established, modified/adapted?
Tailor details:
Procedures
Sensitivity/specificity
Citations [Cronbach’s α]
Validation
Detail:
Dependent & independent > mediators > confounders
RCT: clearly distinguish control from treatment

11. Statistical Analysis Hypothesis testing
Outline your analytical approach
Exploratory data analysis
Modeling approach
Assumptions
Missing data
For qualitative studies, describe content analysis
Assumptions: if your analytical approach is part of your innovation in that it allows you to answer questions that have been previously limited (ex: propensity scores, SEM/path analysis, etc.)

12. Power and Sample Size Depends on what you are starting with:
Secondary data analysis: sample size is fixed
Budget for data collection is limited
Ability to detect the difference* you are trying to see
* meaningful difference: effect size
For the sake of space, power your weakest aim
Make this explicit

13. Challenges & Solutions
Anticipate reviewers’ concerns and outline how you will change gears if necessary
“if/then”
Also in this section can highlight strengths of study

14. Activity
Read Approach sections of successful grants
We will discuss

15. Assignment Revise S & I sections Write Approach sections
Send to group a minimum of 3-5 days before class