Design and analysis of clinical and epidemiological research

Subject description

  1. Type of studies in medicine.
  2. Design of experimental and epidemiological research; power of the statistical tests and sample size calculation, choice of variables and of statistical units, methods for data collection and quality control.
  3. Analysis of experimental and epidemiological research: emphasis is given on the use of regression models
  • Linear regression model, logistic regression model and models for survival data.
  • Missing data.
  • Correlated data.
  • Use of the statistical program R.

The subject is taught in programs

Objectives and competences

Well designed and analyzed clinical and epidemiological research can provide answers to very important questions in the field of medicine. For example, they can demonstrate the efficacy of a new treatment or show the association between a disease and a risk factor.

The aim of the course is to provide the student with the knowledge needed to work independently on the statistical aspects in standard clinical and epidemiological research. The main enphasis is on the design and analysis of data.

Teaching and learning methods

Lectures and laboratory work – practicals using computers. Project development and presentation, working in small groups. Positively evaluated home assignments are required for admission to the exam.

Part of the pedagogical process will be carried out with the help of ICT technologies and the opportunities they offer.

Expected study results

Knowledge and understanding:

The student recognizes the main differences between the different types of studies in medicine, he or she can design a research project and prepare the protocol of the research. The student knows how to choose the most appropriate method for the analysis of data and knows how to prepare a report that presents the design of the research, the statistical analysis and the results.

Basic sources and literature

  • Hulley, Stephen B., Cummings, Steven R., Browner, Warren S., Grady, Deborah G., Newman, Thomas B. Designing Clinical Research: An Epidemiologic Approach, 3rd Edition (2007) Lippincott Williams & Wilkins.
  • Clinical Trials: A Methodological Perspective, 2nd Edition (2005). Wiley Series in Probability and Statistics.
  • Rothman, Kenneth J., Greenland, Sander and Lash, Timothy L Modern Epidemiology, 3rd Edition (2008) Lippincott Williams & Wilkins.

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