Descrizione della formazione

Clinical research is a branch of healthcare science that determines the safety and effect of medications, medical devices, diagnostic tests or procedures and treatment regimens used in humans and patients. In this course partipicants learn to plan and conduct clinical research projects and communicate their results.

Clinical research also covers how to make prognostic assessments, to develop and validate prognostic models and to assess how reliable diagnostic procedures or tests are, for example in terms of sensitivity and specificity. Furthermore, conducting systematic reviews of multiple studies and the meta-analyses of their results will also be covered.

Lernziel

At the end of the CAS in Clinical Research, participants:

• have a thorough understanding of the design, implementation, and analysis of various types of studies in clinical research: registry based observational studies, diagnostic and prognostic studies, randomized clinical trials, systematic reviews and meta-analyses
• are aware of and can apply statistical methods to describe data from clinical studies and use regression models (linear, logistic, Cox, Poisson) commonly used in clinical research using statistical software (Stata)
• can interpret the results of clinical studies, and discuss their relevance for treatment in the clinic and for public health overall
• can locate relevant individual studies and review articles in standard literature databases
• can assess study designs and study protocols and published studies with regard to the quality of data acquisition, measurement methods, and analysis

Piano di formazione

The course consists of
a) 8 Basic Modules:

• Introduction to study designs and epidemiological measures
• Principles of biostatistics
• Introduction to the statistical software Stata and data capture software REDCap
• Regression models in clinical research and epidemiology
• Evaluation of diagnostic and screening tests
• Prognostic studies and modelling
• Randomized controlled clinical trials
• Systematic reviews and meta-analyses

b) 2 elective modules

• Advanced statistical and epidemiological methods
• Health technology assessment
• Writing research proposals and scientific manuscripts

c) a written and an oral exam.

Acquisition: 15 ECTS points