Description: The course aims to provide a comprehensive review of clinical research with emphasis on how to design and how to perform a clinical study and thus give the participant the necessary tools to perform clinical trials. The course contains a comprehensive review on how to plan and perform clinical trials involving humans. Different designs (the randomized controlled trial and other designs including more specialized designs) are reviewed and the planning of a clinical trial is presented. Power calculations are reviewed in detail in order to provide the participant with the necessary tools to give an estimate of the number of subjects needed for a clinical trial. Methods (biochemical methods, diagnostic tests, reliability, coefficient of variation etc.) are reviewed and concepts such as evidence based medicine, collaboration with the medical industry, the legal aspects of a clinical trial (how to write a contract, legal obligations etc.), how to review a paper, practical aspects of biobanks, and how to perform meta-analyses are covered. Emphasis is put on practical exercises related to the topics mentioned above along with lectures. See also the detailed program for the course.

Literature: Andersen D et al: Sundhedsvidenskabelig Forskning – En introduktion 5. udgave, FADL 1999 Chapter 1-4+13+18-20 Lancet 2002;359:881-4, Lancet 2002;359:341-5, Lancet 2002;359:248-52, Lancet 2002;359:145-9, Lancet 2002;359:57-61, Lancet 2005;366:172-4, Lancet 2005;365:1500-5, Lancet 2005;365:1429-33, Lancet 2002;359:966-70, Lancet 2002;359:781-5, Lancet 2002;359 :696-700, Lancet 2002;359:614-8, Lancet 2002;359:515-9, Lancet 2002;359:431-4, Lancet 2005;365:1657-61, Lancet 2005;365:1591-5, Lancet 2005;365:1348-53. Prerequisites:. The course targets Ph.D. students working with clinical research or working in groups dealing with research involving humans. Basic knowledge on statistics, anatomy, and physiology is required. Evaluation No exam, but evaluation of course attendance and group work. The students evaluate the course at the end of the course.

Professor, consultant, PhD DrMedSc Peter Vestergaard, e-mail:

Peter Vestergaard, Lars Jelstrup Petersen, Susanne Ries, Morten Hjulsager, Louise Hansen, Erik Elgaard Sørensen, Søren Risom Kristensen, Henrik Krarup, Jesper Karmisholt, Bodil Steen Rasmussen


2-5 June, 2014

Aalborg University

Zip code:


Number of seats:

12 May, 2014