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This course is primarily concerned with statistical methodology for the design and analysis of clinical trials, planned and conducted within the pharmaceutical industry. Much of the methodology presented is in fact applicable on a broader basis and can be used in observational studies and in clinical trials outside of the pharmaceutical sector; nonetheless the primary context is clinical trials and pharmaceuticals.
The course is aimed at non-statisticians working in the Pharmaceutical Industry and will be suitable for physicians, investigators, clinical research scientists,medical science liaison (MSL), medical writers, regulatory personnel, statistical programmers and senior data managers. Statisticians moving from other areas of application outside of pharmaceuticals may also find the course useful in that it places the methods that they are familiar with in context for their new environment.
• Basic Issues in Clinical Trial Design
• Sampling and Inferential Statistics
• Confidence Intervals and p-Values
• Intention to Treat, Analysis Sets and Missing Data
• Tests for Simple Treatment Comparisons
• Power and Sample Size
• Multiple Testing; Problems and Solutions
• The Analysis of Time to Event Data
• Equivalence and Non-Inferiority