SDBC statisticians can support you in the grant writing process by writing the statistical analysis sections including the power/sample size section of your grant proposal. To write the statistical analysis section, we need to know the following: 1) the population under study, 2) the study design (RCT, prospective/retrospective cohort study, cross-sectional, etc) 3) the intervention/prognostic factor/exposure, 4) the comparison/control group (if applicable), and 5) the outcome of interest and how it will be measured. We can also help with deciding the above factors. For example, an alternative study design or outcome measure might be more effective at answering your research question(s) than what you had planned.
The following documents provide more information on the elements of study design that are helpful for developing an effective statistical analysis section.
- WRITING AN EFFECTIVE RESEARCH PROPOSAL Marja J. Verhoef, PhD Robert J. Hilsden, MD MSc FRCPC
- Bridging Clinical Investigators and Statisticians: Writing the Statistical Methodology for a Research Proposal Beverley Adams-Huet, MS and Chul Ahn, PhD Journal of Investigative Medicine Volume 57, Number 8, December 2009 Writing the Statistical Analysis Plan
The following table summarizes the role of statisticians in developing the statistical plan for a grant proposal.
| Role of the Statistician in Developing the Statistical Plan |
Clarify the research questions or hypothesis.
|
Identify the outcome variables related to the research
|
| Does the study design appropriately and adequately address the proposed hypothesis? |
| Are the issues of the bias, blinding, or stratification properly handled in the study? |
| Are the assumptions used for sample size estimation clearly elaborated and supported by proper preliminary data and/or references? |
| Is there an appropriate data and safety monitoring plan, interim analysis plan, or preestablished early stopping rule? |
| Is there a clearly specified, appropriate data analysis plan? |
| Is there an appropriate data and safery monitoring plan, interim analysis plan, or preestablished early stopping rule? |
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Acknowledging the SDBC
Please use the following text to acknowledge the CTSI Study Design and Biostatistics Center:
"This investigation was supported by Translational Research: Implementation, Analysis and Design (TRIAD), with funding in part from the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UM1TR004409. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."
"This investigation was supported by the Study Design and Biostatistics Center (SDBC), with funding in part from the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UM1TR004409. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."