17
17
6a Study Design and Proposal Development Assistance
21 1bAssistance in planning studies entails helping to define and refine the study question into testable hypotheses answerable by the available data, and then providing an appropriate study design that enables answering of this question. Design issues include identification of appropriate study endpoints, the type of design, sample size calculations to demonstrate feasibility and sufficient statistical power, implementation and logistical details, and cost. The quantitative background of core members equip them to help investigators focus and refine study hypotheses based on available data and their limitations. For example, if a proposed study design is not feasible in terms of cost, 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. Additionally, approaches such as blocked or randomized designs can be used to increase the probability of a representative sample and avoid confounding, contributing to assurance of reproducible and replicable research.
2 280The study design assistance of the SDAB Core is also integrated with the Research Ethics Program Core (REP). 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.
5 57 21 21 25 49 5 25 49 25 1f 1f 49 45 21 3b 21 25 1d