Topic outline

Incidence & Prevalence

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Fundamentals of Statistics

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Principles of Sample Size Calculation

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Relevance of the Statistical Analysis Plan (SAP)

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Clinical trials are complex scientific experiments aiming to generate evidence regarding the safety and efficacy of treatments. Data generated by clinical trials are used for regulatory submissions and/or publications in scientific journals. It is therefore important that the way the data will be analysed and presented are well defined upfront.


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