Entry requirements

180 credits in medicine/pharmacy

Learning outcomes

This course aims to provide students with a broad and deep knowledge of most stages in a drug's development from idea to completed product. Special emphasis is placed on clinical trial methodology, where the students will learn to plan a larger clinical trial.

On completing the course, the student shall demonstrate the ability to:

Knowledge and understanding

• Be able to describe the basic principles of pharmacokinetics (PK) and the most common types of PK studies.
• Be able to describe the principles for how an ethics review application is formulated.
• Be able to explain the principles of clinical trials according to Good Clinical Practice (GCP).
• Be able to describe basic biostatistics and the statistical principles for clinical trials.
• Be able to describe the regulatory procedures for the registration of new drugs and the other roles of Regulatory Affairs in clinical drug development.
• Be able to describe the purpose of clinical trial monitoring and have basic knowledge of how a monitor prepares, initiates, monitors, and finishes a clinical trial.

Competence and skills

• Be able to calculate an estimate of the sample size needed and describe appropriate biostatistical methods for analyses of primary and secondary endpoints in a clinical trial.
• Based on medical and biostatistical considerations, be able to develop an appropriate study design for a phase III study based on a given phase II study.
• Be able to design and follow a monitoring plan and to report in accordance with this plan.
• Be able to write a complete phase III clinical trial protocol in accordance with GCP guidelines and EU directives.
• Be able to summarize a clinical trial and present it in both a written report and an oral presentation.
• Based on a given clinical trial, be able to design participant information in accordance with current regulations.

Judgement and approach

• Demonstrate the ability to critically evaluate pharmacokinetic (PK) and pharmacodynamic (PD) studies and their significance for subsequent drug development.
• Demonstrate insight into and be able to discuss relevant ethical and regulatory aspects of a clinical trial.
• Be able to describe and evaluate the risk-benefit ratio of a clinical trial.
• Be able to critically discuss and analyze a given study protocol for a clinical trial.

Content

The course consists of the following sections:

• Introduction and ethics in clinical trials
• Pharmacokinetics and pharmacodynamics, PK/PD
• Pre-clinical drug development and toxicology
• Basic statistics for clinical trials
• Trial methodology with applied biostatistics
• Registration of new drugs - Regulatory affairs
• Clinical trials in various diagnostic areas
• Monitoring
• Protocol writing
• Participant Information

Instruction

The course is given mainly as a series of lectures, but also consists of compulsory group assignments, voluntary study visits, and individual projects that are presented to teachers and fellow students.

Assessment

To pass the course, students must pass all presentations, group assignments and written tests, as well as the final examination.

At the final examination, the students will write a complete clinical trial protocol and present it before a smaller group of students as well as examiners in a respondent/opponent form

If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the University's disability coordinator.