Design and Analysis of Randomized Clinical Trials
In a rapidly changing (professional) context, lifelong learning has become a must. With microcredentials Ghent University offers a new type of course for a broad group of lifelong learners.
Practical information:
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- Prerequisites: The basics of statistical concepts, techniques and inference, knowledge of linear regression and categorical data analysis are considered known.
- Price: € 890
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This course builds on the course on Principles of statistical data analysis, Analysis of continuous data and Categorical Data Analysis to teach knowledge and ideas to draw evidence from randomized studies with a focus on applications in medicine and public health. It will provide the student with an understanding of statistical principles, methodology and concepts involved in clinical research across the various phases. The student should acquire the skills to design a clinical trial, be aware and understand the limitations related to clinical trials, be aware of formal guidelines and be able to analyze the data according to appropriate statistical techniques.
Detailed content
- Clinical Trials
- Protocol document and the role of the statistician therein
- Types of experimental designs (parallel, cross-over, factorial)
- Endpoints and estimands
- Sample Size/Power calculations
- Treatment allocation
- Data analysis and prognostic factors
- Concepts and methodology for (data-dependent) stopping and early termination of trials
- (interim analysis, adaptive designs and data monitoring committees)
- Meta-analysis
- Reporting of results, potential pitfalls and data quality
Final competences
- The student has knowledge of statistical methods (including designs) for the analysis of clinical trials.
- The student can:
- give well-argued advice on clinical trial designs.
- properly perform advanced clinical trial data analyses.
- can draw appropriate conclusions from statistical analyses related to the clinical trial taking into account possible study design related bias.
- can report the results to scientists from subject matter fields.
- can critically comment on published clinical research.
Book recommendations
- Fundamentals of clinical trials. Friedman L., Furberg C., DeMets D. Springer-Verlag, New York 1998 (3rd edition)
- Pharmaceutical Statistics: practical and clinical applications. Bolton S., Bon C. Informa Health Care, 2004.
- Statistical Issues in Drug Development. Senn S. Wiley, Hoboken and Chichester (1997).
- Clinical Trials: A methodologic Perspective. Piantadosi S. Wiley & Sons, New Jersey, 2005 (2nd edition).
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