CAS in Clinical Research in Health Care Organisations

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 the «CAS in Clinical Research in Health Care Organisations» you’ll 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.

Clinical research uses epidemiological and biostatistical methods to analyze and interpret data. The CAS also covers how to use a statistical software for study planning and data analysis. The ultimate aim is to draw reasonable and appropriate conclusions from clinical studies while acknowledging methodological limitations and statistical uncertainty.

Goals of the Course

In the CAS in Clinical Research you will learn to plan and conduct clinical research projects for a well-defined re- search question, to describe data from clinical studies, and to apply statistical methods and regression models commonly used in clinical research. The CAS also covers prognostic research and systematic reviews of multiple studies and meta-analyses of their results. Finally, you will also learn how best to communicate the results of clinical research.

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

• Have a thorough understanding of the importance of having a precise research question and how to trans-late this question into the design, implementation, and analysis of various types of studies in clinical re- search: observational studies, diagnostic and progno-stic studies, randomized controlled clinical trials, syste- matic reviews and meta-analyses.
• Can apply statistical methods to describe data from clinical studies and use regression models (linear, logi-stic, Cox, Poisson) commonly used in clinical research, and be able to use a statistical software (Stata).
• Can assess study designs and protocols and published studies with regard to the quality of study implemen-tation, data acquisition, measurement methods, and analysis.
• Can interpret the results of clinical studies, and dis-cuss their strengths and limitations and the relevance for treatment decisions.

Structure of the CAS

The CAS comprises approximately 10 course modules which require around 350-450 hours of work, leading to the acquisition of 15 ECTS points.

Language

All courses, exams, and course materials are in English.

Course Program

The program involves approximately 450 hours of work in modules that are generally 3-day courses. Completion of the CAS usually takes 2 years, but it can be done in 1 or 3 years, and leads to the acquisition of 15 ECTS points. Participants also have the opportunity to attend elective modules according to their particular interests.

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

Advanced Modules

Participants can focus on their own interests and streng-then aspects of the basic modules by choosing elective courses in up to 2 of the advanced modules:

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

Organization and Conduct

The course modules are organized by the Institute of Social and Preventive Medicine in close collaboration with other institutes conducting clinical research at the University of Bern, the Inselspital and with the Clinical Trials Unit.

Course Directors CAS Clinical Research

• Prof. Dr. Marcel Zwahlen
  Institute for Social and Preventive Medicine, University Bern
• PD Dr. Sven Trelle
  Clinical Trial Unit, University Bern

Program Management MAS

Program Management MAS  in Leading Learning Medical Organisations

• Prof. Dr. Marcel Zwahlen, Institut für Sozial- und Präventivmedizin Universität Bern
• Prof. Dr. med. Stephan Windecker, Medizinische Fakultät Universität Bern & Inselspital
• Prof. Dr. Claudio Bassetti, Medizinische Fakultät Universität Bern & Inselspital
• Dr. med. Christina Venzin, ISPM Universität Bern, college M & Spital Davos
• Dr. Christof Schmitz, college M

The CAS CRHCO is a continuing education program aimed at health professionals and graduate students interested in patient- oriented clinical and health services research.

The participant should possess a Master of Science degree.

Exceptions can be approved by the study management "sur dossier".

CHF 9'600  (payment in 3 installments possible)