Examination arrangement

Course content

Clinical trials are fundamental to gain reliable knowledge about the effectiveness and safety of a new drug, a surgical procedure, a lifestyle intervention, a rehabilitation method or a medical device. This knowledge is essential to be able to make decisions about whether clinical methods should be recommended, continued, or discontinued.

The course provides a detailed introduction to randomized controlled trials (RCTs) and will cover all important aspects from design to publication. Emphasis will be placed on practical aspects such as patient recruitment and data collection. Other types of clinical study design will also be covered. The course will also provide knowledge on how to assess scientific quality in published literature.

After completing the course, students should be able to plan, carry out and publish their own clinical studies of high scientific quality. The course will offer an inspiring environment that facilitates networking, promotes career development and motivates future clinical research.

Learning outcome

After completing the course, the student should have acquired the following knowledge:

• Scientific, ethical and practical aspects of clinical research.
• Be able to contribute to the improvement of design and methods in clinical research.

After completing the course, the student should have acquired the following skills:

• Be able to design, plan, conduct and publish a clinical trial of high quality.
• Be able to create a study protocol for a clinical trial.
• Be able to assess the quality of published clinical trials.
• Be able to formulate problems at a given hypothesis.
• Be able to assess the appropriateness of using different methods and tools in clinical trials.

After completing the course, the student should have acquired the following general competence:

• Be able to identify new relevant ethical and scientific issues related to the design and implementation of a clinical trial.
• Be able to disseminate clinical research through recognized national and international channels.
• Be able to conduct clinical research with professional integrity.

Learning methods and activities

The course consists of three seminars, usually in September, October, and November. The course consists of lectures, group work and two short home assignments. To be allowed to take the examination, at least 80% attendance of the lectures is mandatory.

Compulsory assignments

• Assignments
• Participation in lectures

Further on evaluation

Homework will be assigned after session 1 and session 2. Estimated work-load is 2-3 hours. The homework is assessed as approved/not approved. If not approved, the student gets one additional opportunity to hand in an improved assignment. This applies to both mandatory submission requirements. Compulsory activity is valid for 4 semesters.

Re-sit examination will be arranged as a written exam.

Recommended previous knowledge

Master's degree within the field of health sciences or medicine.

Required previous knowledge

Master degree or similar. Candidates with a lower degree will be assessed individually.

Course materials

Warren S. Browner et al. Designing Clinical Research (fifth edition), Wolters Kluwer (2023). ISBN-13: 978-1-975174-40-8.

Slides presented at the course.