Clinical Trials

Course Code :2037GENEP1
Study domain:Epidemiology
Academic year:2017-2018
Semester:2nd semester
Contact hours:0
Study load (hours):84
Contract restrictions: Faculty decision based on student file
Language of instruction:English
Exam period:exam in the 2nd semester
Lecturer(s)Jean-Pierre Van Geertruyden

3. Course contents *

Clinical trials are the “gold standard” in evidence-based medicine leading decisions making in the healthcare sector. Because they assess efficacy and/or safety of interventions with a limited risk of bias clinical trials are considered the state-of-art research designs promoting new treatments development.  The emphasis in this course is on the methodological principles and on the practice of the randomized clinical trial. We will also pay attention to the principles of assessing the impact of a medical treatment on the risk of unexpected outcomes. The emphasis is on the correct formulation of the research question in the light of the clinical and legal relevance of the study results and on the requirements for validity in the non-experimental trial. The introduction of ever new medicines for the same disorders requires a specific approach to the risk-benefit analysis. The determination of safety and risk in drug treatment is done on the basis of observational pharmaco-epidemiological studies (proof of safety’-, ‘proof of effectiveness’- studies).

These form the logical step after the randomized clinical trials which are aimed at demonstrating the efficacy (effectiveness). In this course, the key concepts of pharmaco-epidemiology and of  drug safety research will be considered.