How to Structure the “Approach” Section (Basic Science)

Nov 6, 20230 likes5 views

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

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

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?

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?

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

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

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

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

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”

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

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.”

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

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How to Structure the “Approach” Section (Basic Science)

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?

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How to Structure the “Approach” Section (Basic Science)

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