LFU:online

The students can name and explain basic principles and methods of biostatistics. They know about the importance of careful statistical planning of clinical trials.

The students obtain insights regarding the practical work of a statistician in academics and in the pharmaceutical industry. The students will esteem the importance of applying statistical methods in the process of drug development.

Part 1: descriptive statistics and contingency tables, probability, correlation and regression, confidence intervals and significance testing, logistic regression, survival analysis, sample size estimation

Part 2: the role of statistics in drug development with a historical overview, design of clinical trials, randomization, blinding, measuring treatment effects, planning and reporting of trials, data collection. Special topics such as  multiplicity and interim analysis, missing data and intention-to-treat, dose finding studies, non-inferiority and equivalence trials, cross-over trials, multicenter trials, meta-analysis, pharmacogenetics and mendelian randomization

Lecture with interactive elements involving student participation, audience response systems, online handouts

written exam

The lecture will be divided into two parts: (1) Introduction to Biostatistics and (2) Statistical Issues in Drug Development