University of Zagreb School of Medicine

After successfully finishing the course, attendant will gain knowledge about controlled clinical trials as the only scientific evidence of the value of therapy, will become familiar with trials of comparative efficacy, phase IV clinical trials, ethics of clinical trials and distinguishing interventional from non-interventional trials. Moreover, the attendant will gain basic skills in writing the projects and grants as well as making statistical analyses.

By its content, the course includes important parts of the characteristics of clinical medical research in the form of lectures, seminars and excercises. It is attempted to illustrate these topics to attendants through concrete examples of clinical trials and the experiences of clinical pharmacologists. The course consists of the following topics: Controlled clinical trials as the only scientific evidence of the value of therapy, Ethics of clinical trials, Trials of comparative efficacy in medicine, The choice of diagnostic procedure in the example of kidney tumor, Statistics in clinical trials: friend or foe, Clinical medical trials in clinical pharmacology, Difference between interventional and non-interventional trials, Examples of randomized clinical trials, International scientific collaboration, writing of projects and securing grants, Phase IV clinical trials, Comparisons of cost-efficacy: examples of pharmacoeconomic analyses. The course ends by written exam.

• Dr. Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady, Thomas B Newman. Designing Clinical Research. Fourth Edition. 2013 by Lippincott Williams and Wilkins, ISBN 978-1-60831-804-9
• Jeremy Howick. The Philosophy of Evidence-based Medicine. 2011 by Wiley-Blackwell, ISBN: 978-1-4051-9667-3
• Khalid Khan, Regina Kunz, Jos Kleijnen and Gerd Antes. Systematic Reviews to Support Evidence-based Medicine. Second Edition. 2011 by Taylor and Francis Group. ISBN: 978-1-85315-794-3
• Aviva Petrie and Caroline Sabin: Medical Statistics at a Glance, July 2009, Wiley-Blackwell, ISBN: 978-1-4051-8051-1
• Statistics at Square One (Paperback) by Michael J. Campbell WileyBlackwell; 11th Edition edition (21 Aug 2009), ISBN-13: 978-1405191005
• najnoviji znanstveni pregledi vezani uz sadržaj predmeta
• Kenneth W. Goodman. Ethics in Evidence-based medicine. Cambridge University Press 2003. ISBN-13: 978-0-511-05521-8 eBook
• Tom Brody. Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. 2012 Elsevier Inc. ISBN: 978-0-12-391911-3

Lectures, seminars and practical work.

Written exam with 45 questions.