Clinical trials are essential in development of new drugs and medical devices that should undergo rigorous and systematic testing in patient volunteers to ensure well documented safety and effectiveness profiles. Clinical trials are prerequisite for approval and will offer meaningful value for patients’ use in a broader popgemulation. There are four phases of clinical trials (I, II, III and IV) and the goal of this course is to expose students to essential elements of these phases.
Topics encompass a number of areas from design to conduction and reporting a clinical trial such as different types of clinical trial design, objectives and outcomes, prevention and treatment of missing data in clinical trials through changes in study design and use of appropriate statistical methods, biomarkers, rules and guidelines to safeguard the reliability of trials, policy decisions, roles of stakeholders including pharmaceutical firms, commercial influence on clinical trials, patenting, post-marketing drug surveillance, reporting and monitoring adverse reactions, pharmacovigilance, drug use in community, role of media and pharmacoeconomics.
This course consists of formal lectures given by mentors and experts, with extensive background in clinical trials, who will guide students through the learning process.
|Name of exam||Perspectives of Clinical Trials in Drug and Medical Device Development|
|Type of exam|
|Assessment||7-point grading scale|
|Type of grading||Internal examination|
|Criteria of assessment||The criteria of assessment are stated in the Examination Policies and Procedures|
Please contact the programme student counsellors if you consider applying to the education and you have questions.
Please consult the Moodle page for your semester and contact the semester coordinator if you have academic questions, or the study secretary if you have administrative questions.
All other enquiries may be directed to Helene Nørgaard, secretary of the Study Board.
|Danish title||Kliniske undersøgelser ved udvikling af medicin og medicinsk udstyr - TM|
|Language of instruction||English|
|Location of the lecture||Campus Aalborg|
|Responsible for the module|
|Study Board||Study Board of Medicine|
|Department||Department of Clinical Medicine|
|Faculty||The Faculty of Medicine|