Scott G. Filler, MD Professor-in-Residence of Medicine at UCLA and the Lundquist Institute 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: Review Criteria
• 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: Review Criteria
• 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 Supports 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
• Rigor and Transparency
o Strong scientific premise (Significance)
o Scientific rigor (Approach)
• Blinding, sample size, reducing bias
o Consideration of relevant biological variables, such as
sex (Approach)
• Include animals of both sexes if feasible
o Authentication of key biological and/or chemical
resources (separate page)

9. 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”

10. Anticipated Results and
Potential Pitfalls
• What do you think the results will be?
• Creativity and flexible thinking very important
• Interesting alternative outcomes
• What if hypothesis is not supported?
• Never present a potential pitfall for which you
don’t have a good solution

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?