Analytical Methods for Regulat

Course Description

This course will give the student the fundamental knowledge of statistical concepts and analytical methods as applied to biomedical science and clinical trials. It will emphasize basic concepts of methodology and experimental design, quantitative analysis of data and statistical significance. A case study approach will be used to cover the basic designs of clinical trials with emphasis on appropriate methodologies, endpoint variables, control groups, blinded studies, eligibility criteria and placebo control. The course will cover statistical analysis including probabilities and variables. Students will be required to design and implement a full protocol for a fictitious drug or medical device elucidating the data for approval.

Learning Outcomes

• Understand basic computational statistics.
• Understand basic clinical trial design.
• Understand the concepts of randomizing and blinding.
• Understand basic clinical trial methodology.
• Classify various types of clinical trials.
• Analyze final data.
• Analyze interim data.
• Develop sample size for a clinical trial.
• Evaluate efficacy of a clinical trial product.
• Evaluate safety data of a clinical trial.
• Manage data from a clinical trial.
• Development and implement a full scale clinical trial protocol with emphasis on data management and analysis.