CTSI R Workshop: How to Structure the “Approach” Section of a Grant Application Scott G. Filler, MD Professor of Medicine at Lundquist Institute/Harbor-UCLA and UCLA Leader, CTSI Pilot Translational and Clinical Studies Program Co-Leader, CTSI KL2 Institutional Development Core

1. Approach
(Basic Science)
Scott G. Filler, M.D.
Lundquist Institute for Biomedical Innovation
at Harbor-UCLA Medical Center
sfiller@ucla.edu

2. Approach
• Are the overall strategy, methodology, and analyses well-
reasoned and appropriate to accomplish the specific aims
of the project?
• Have the investigators included plans to address
weaknesses in the rigor of prior research that serves as
the key support for the proposed project?
• Have the investigators presented strategies to ensure a
robust and unbiased approach, as appropriate for the
work proposed?

3. Approach
• Are potential problems, alternative strategies, and
benchmarks for success presented?
• If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky
aspects be managed?
• Have the investigators presented adequate plans to
address relevant biological variables, such as sex, for
studies in vertebrate animals or human subjects?

4. Approach--Overall Layout
• Preliminary data
• Aim 1
o Rationale and overall approach
o Experimental methods
o Anticipated results
o Alternative outcomes (potential pitfalls)
o Future directions
• Aim 2
o Rationale and overall approach
o Experimental methods
o Anticipated results
o Alternative outcomes (potential pitfalls)
o Future directions

5. Approach--Alternate Layout
• Aim 1
o Preliminary data
o Rationale and overall approach
o Experimental methods
o Anticipated results
o Alternative outcomes (potential pitfalls)
o Future directions
• Aim 2
o Preliminary data
o Rationale and overall approach
o Experimental methods
o Anticipated results
o Alternative outcomes (potential pitfalls)
o Future directions

6. Preliminary Data
• Present compelling preliminary data
o Supports premise of the work
o Demonstrates feasibility
o Sparks interest, but leaves reviewer wanting to learn more
• Potential pitfalls in preliminary data
o Clear weaknesses
o No statistical analysis
o Support alternative hypothesis

7. Approach
• Describe overall approach and the controls
• Only mention key details
• Need power calculations for animal studies
o Many details of animal studies can be move to Vertebrate
Animals section
• Address sex as a biological variable

8. Approach
• Potential pitfalls
o One aim depend on another *
o Excessive detail
• Detracts from overall message
• Target for criticism
o Densely written prose
“If reading a grant gives the reviewer a headache, that grant is
unlikely to receive a good score”

9. Anticipated Results and
Potential Pitfalls
• What do you think the results will be?
• Creativity and flexible thinking very important
• Interesting alternative outcomes—make a bug into a
feature

10. Anticipated Results and
Potential Pitfalls—Key Points
• What will you do if hypothesis is not supported?
• Never present a potential pitfall for which you don’t
have a good solution
• Don’t say, “The investigative team has substantial
experience with this work and thus do not anticipate
any technical problems.”

11. Future Directions
• Where is your research going?
• What will be its impact?
• How can the specific information learn be
applied to a broader question?