Entry requirements

At least 180 credits within the disciplinary domains of Medicine and 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.

At the end of the course the students should know:

- Basic principles of pharmacokinetics (PK) and the most common types of PK studies

- Clinical trial methodology according to Good Clinical Practice (GCP)

- Basic biostatistics, with focus on power calculations and analysis of different primary and

secondary variables in clinical trials.

- How to design a phase III study from a previous phase II study

- Regulatory procedures at the registration of new drugs and the other roles of Regulatory

affairs in clinical drug development

- Basics of clinical trial monitoring

- How to write a complete clinical trial protocol

Content

The course consists of the following sections:

1 week: Introduction and ethics in clinical trials

2 weeks: Pharmacokinetics, PK/PD

1 week: Pre-clinical drug development and toxicology

2 weeks: Basic statistics for clinical trials

2 weeks: Trial methodology with applied biostatistics

1week: Registration of new drugs - Regulatory affairs

4 weeks: Clinical trials; including special areas, cardiology, endocrinology, oncology, neurology and psychiatry.

1 week: Monitoring

6 weeks: Protocol writing

Instruction

The course is given as a series of lectures and seminars, but also consists of study visits, individual projects, and group assignments. Parts of the course are web-based and we use the web platforms of Uppsala University.

Assessment

Examinations are arranged continuously as seminars or written examinations. At the final exam, the students will write a complete clinical trial protocol and present it before a smaller group of students and two examiners. Each student will also act as opponent on one protocol

In order to be examined the student must have fulfiled the compulsory parts of the course. To receive a passed on the course, all compulsory parts and a passed examination are required.

Students who have not passed the examination have the right to take the examination 4 additional times (= total 5 examinations). If the student can claim special reasons, the programme committee may admit additional examination. Every time the student actually sits for an examination will be counted as an examination. Submission of so called blank examination is counted as an examination.