Introduction to Biostatistics: Real Life Examples in Clinical Research and Development (+CILS)

20.02.2019; 13.03.2019; 27.03.2019; 10.04.2019; 08.05.2019; 22.05.2019; 08 :15-12 :00, UniMail room M3220

Prof. Eva Cantoni, Geneva School of Economics and Management

Dr François Curtin, UNIGE Dr David Warne, UNIGE

The course offers an introduction to different aspects of biostatistics focusing on how biostatistics is used in drug development and health care research. Students will see how biostatistics can be applied to medical and pharmaceutical research to respond to critical questions of medicine and biology. The course should elicit the interest of students to pursue further study in the field of biostatistics or to consider starting a professional career in this applied field of statistics. With six blocks, the course discusses topics of biostatistics which are key to support the development of new drugs and to explore medical questions from a statistical perspective. The course highlights some statistical issues and underlines the role of applied statistics in drug development and health care research. It builds on the theoretical concepts taught earlier during the Master's programme or during an introductory statistics course focusing on the practical application of biostatistics. 1. Overview of Biostatistics: we introduce the clinical development of new drugs and describes the need for the clinical trial methodology to support this development; some trial examples are discussed. 2. Trial Design I: Different experimental designs of clinical trials (parallel, cross-over, cluster, sequential, adaptive trials) are presented with their main statistical methodologies, advantages and issues. 3. Trial Design II: Operational and technical issues related to the performance of clinical trials are presented along with the main regulatory texts related to clinical studies. Technical points such as randomization of patients, sample size and power calculations are introduced. 4. Trial Analysis I: The analysis of biostatistical data with emphasis on specific estimators and statistical models frequently used in trials, including survival analysis, are presented. The methodology to analyse data in pharmaceutical trial is discussed, as well as related issues such as missing data. 5. Trial Analysis II: Analysis, review of data and monitoring of results are discussed. Alternative approaches such as Bayesian models and equivalence/non-inferiority studies are presented. 6. Other Applications of statistics in medicine: Some other applications of biostatistics useful for the understanding of disease causation (epidemiology), the synthesis of studies (meta-analysis) and the effect of medications over large populations (pharmaco-epidemiology) are discussed

UniMail, Room M3220, Genève

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