1. Grant Writing: Specific Considerations in Clinical Studies Ravi Retnakaran MD MSc FRCPC Leadership Sinai Centre for Diabetes, Mount Sinai Hospital University of Toronto May 27, 2008

2. Grant Writing – Clinical Studies Many of the characteristics of successful grant writing pertain to all types of grants However, there are some considerations that are particularly relevant to clinical studies

3. Consider the Grant Review Panel Members of panel may not be experts in your area Members are reviewing many grants  consider the possibility of reviewer fatigue => Message in your proposal must be very clear

4. Tailoring Grant to the Committee Remember that, depending on the committee mandate and membership, there may be particular focus on different aspects of the grant: eg. Anticipate that a Population Health committee will be interested in statistical considerations (eg. sample size, statistical analysis plan)

5. Statistical Considerations Must show that research group is capable of performing the statistical analyses required for the proposed study: –Demonstrated expertise within the proposed research group –Consider addition of statistician to research team –Letter of collaboration from statistician

6. Statistical Plan Provide detailed statistical plan, including the following: –Primary/secondary outcome measures –Types of statistical analyses planned (eg. types of modelling and statistical tests) –Covariates that will be considered –Subgroups that may be of interest –Validation of measurement instruments –Demonstrate recognition of statistical issues that may be relevant to these analyses

7. Statistical Power In clinical studies, it is important to provide some indication of anticipated statistical power  power calculation Power calculation is often very much an estimate Can include a table in appendix showing anticipated differences that can be detected for different sample sizes and different effect sizes

8. Human Subjects – Study Population Indicate study population, including specific inclusion/exclusion criteria Indicate target sample size, anticipated rate of recruitment, and recruitment plan Can include a timeline for the study => These factors can all reflect on the feasibility of the study plan

9. Human Subjects - Safety Discuss any safety issues relevant to proposed study Discuss any ethical issues Institutional Research Ethics Board approval

10. Considerations Relevant to Reporting of Study Considering issues relevant to reporting of the study may indicate things to consider in the grant proposal: 1. Observational study –STROBE statement 2. Clinical trial –Registration of clinical trial –CONSORT guidelines

11. Sample Clinical Grant I. Rationale II. Hypotheses, Objectives and Research Questions III. Background and literature review -- concluding with limitations of existing knowledge and significance of proposed study

12. Sample Clinical Grant (continued) IV. Research Plan: - A. Study population - B. Study design - C. Procedures (including recruitment, tests, measurements) - D. Statistical analysis plan - E. Sample size and power - F. Timeline - G. Feasibility and limitations - H. Ethical issues, risks and side effects