General provisions

The course may be included as an elective advanced course in the Master of Science Programme in Pharmacy and the Bachelor of Science Programme in Pharmacy. It can also be included in the Master's (120 credits) programme in Drug Discovery and Development or the Master's (120 credits) programme in Pharmaceutical Modelling.

Entry requirements

150 credits of which 120 credits biomedicine, biology, pharmaceutical sciences, chemistry and/or science/technology. Earlier studies should contain 7.5 credits pharmacokinetics and 7.5 credits pharmacology.

Proficiency in English equivalent to the Swedish upper secondary course English 6.

Learning outcomes

On completion of the course, students should be able to:

• Give an account of key concepts in design, implementation, analysis and reporting of clinical trials from phase I to phase IV
• Choose appropriate designs and study variables for different research questions and fields of therapy
• Define and explain concepts that are important when planning a clinical study, study design and execution of clinical studies
• Choosing a randomisation strategy for a specific problem and measures to avoid systematic deviation
• Carry out study size calculations including model-based calculations and be able to account for how different assumptions influence the study size
• Specifying different parts of a study protocol and composition of a case report form (CRF)
• Critically review and analyse publications and reporting of clinical trials with regard to contents and assess choice of design and study endpoint in relation to the research questions
• Give structured and nuanced feedback in written and oral presentations as a part ofi their skills training
• Argue and discuss different proposed solutions and make decisions on given issues as a part of their skills training

Content

The course describes the different phases in clinical drug development and the different roles and actors within a study team. Central focus areas in the course include choice of design and study variable for a clinical questions as well as appropriate methods for randomisation and study size calculation.

Structure and design of a study protocol and case report form (CRF) are being discussed and highlighted. Ethical and regulatory requirements and guidelines are studied as well as how monitoring can ensure that qualitative results are received. Finally, study reports and/or publications are analyzed with regard to design and study variables in relation to question, as well as recommendations for how studies should be reported.

The students work independently and in groups and report in writing and orally throughout the course. In connection with these components, feedback is provided. Skills training is carried out during the course through feedback in connection with the written components, the oral components and the group assignments. The students are consistently trained in arguing, discussing and making decisions.

Instruction

The teaching consists of lectures, workshops and individual assignments or group assignments.

Compulsory parts of the course:

Active participation in workshops and group assignments.

The course is given in English when necessary.

Assessment

Throughout the course, continuous examinations are carried out. The course is divided into five parts, and each part is completed with an examination. 2 oral examinations (each 1.5 credits) and 3 written examinations as minor essay (each 1.5 credits). For a pass in the course, a pass in all examinations is required. A chance to carry out a failed compulsory component can be arranged only during the next course and only if space allows.

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.

Other directives

The course partially overlaps (1.5 credits overlap) with Clinical Drug Trials with Applied Biostatistics 3FB620 and Clinical Drug Trials with Applied Biostatistics, Advanced Course C 3FB052 and can only be partially included in the same degree.