Project Course: Clinical Trial

Aim

Knowledge and understanding

Having completed the course, the student is expected to be able to:

• Describe the different phases in development of new drugs
• Describe the principles for clinical studies of medical technology products
• Describe the overall quality control principles, Good Clinical Practice (CPL), and regulations for clinical trials
• Explain the principles of different type of design for comparing clinical trials; controlled, randomised and masking
• Describe the structure and content of a study protocol
• Describe what it takes to plan, perform and complete a clinical trial

Skills and abilities

On completion of the course, the student shall be able to:

• Critically analyse, compare and discuss different forms of clinical trials concerning design and statistical methods
• Make use of a study protocol and be able to implement it in a clinical trial process
• Write a study synopsis

Judgement ability and approach

On completion of the course, the student shall be able to:

• Identify, formulate and discuss ethical issues that may arise in clinical trials
• Assess advantages and disadvantages with different study design in different types of clinical trials
• Identify the various regulations that surround clinical trials

Content

This is a basic course in clinical trials. Principles and regulations during the different phases in drug development are studied based on ethical, scientific and methodology aspects. The course also covers processes in drug development, including the role of the patient and other key roles necessary to complete a correct clinical trial. Practical assignments in clinical trial supported by theoretical studies prepare the students to their future professional role.