Prerequisite/Recommended prerequisite for participation in the module

1st semester Master of Science in Medicine with Industrial Specialization, Profile: Translational Medicine TM

Content, progress and pedagogy of the module

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.

Learning objectives

Knowledge

• Have an in depth understanding of different steps for planning, practical execution and completion of a clinical trial.

Skills

• Analyze, compare and discuss critically and systematically different forms of clinical trials concerning design and statistical models.
• Identify, formulate, discuss and evaluate issues, rules and responsibilities in clinical trial activities.
• Choose relevant problem-solving techniques in the design and analysis of clinical trials
• Apply gained knowledge and skills to design a clinical trial following regulations and requirements and analyze it.

Competences

• Assess product safety and efficacy utilizing monitoring tools, standards, and approaches while considering global benefits to people and economies.

Type of instruction

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.

Exam

Exams

Name of exam	Perspectives of Clinical Trials in Drug and Medical Device Development
Type of exam	Written exam
ECTS	5
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

Additional information

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.