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Medical Statistics and Analysis of Clinical Trails: Course Outline

A necessary companion to well-designed clinical trial is its appropriate statistical analysis.

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Course Outline (STAT-703)

Study designs in epidemiology, Defining and assessing heterogeneity of effects, interaction. Sensitivity and specificity of diagnostic test, Cohort Study designs, statistical power and sample size computations. Log-linear models, Survival data, Proportional hazards model, multivariate survival data. Causal Inference, Longitudinal data. Communicating results of epidemiological studies. Introduction to clinical trials, bias and random error in clinical studies, Data management, database design, data collection systems for good clinical practice, Design of clinical trials: parallel vs. cross-over designs, cross-sectional vs. longitudinal designs, objectives and endpoints of clinical trials, Surrogate endpoints, selection and design of trials with surrogate endpoints, analysis of surrogate endpoint data. Meta-analysis of clinical trials.

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