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Study Design and Proposal Development Assistance

Assistance in planning studies entails helping to define the study question and then moving from the scientific question to an appropriate study design. Design issues include study endpoints, the type of design, and feasibility in terms of sample size requirements, implementation issues, and cost. Core members help investigators focus and refine study hypotheses. For example, if a proposed study design is not feasible in terms of costs, an experienced biostatistician and/or epidemiologist can help refocus the question or change the design, such as reducing the number of endpoints or measurements, while maintaining the goal of getting answers to relevant scientific hypotheses.

The study design assistance of the SDAB Core is also integrated with the Research Ethics Core (REC). For example, it is common for ethical considerations to be involved in the choice of study designs; a purely "optimal" study design in terms of statistical science may not be feasible due to ethical considerations regarding particular populations, such as pediatric studies, appropriateness of randomization, choices of control groups, or timing of informed consent. Members of the REC are available for the study design process, to provide expertise when the areas overlap.

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