Aim and Content

The randomized controlled trial (RCT) is a central method in clinical research. Both as readers of clinical scientific literature and as physicians with responsibility for patients that participate in clinical studies, and as researchers, it is necessary for future doctors to have basic knowledge about randomised trials. This course covers the various aspects of design and planning of randomised studies such as ethical rules, randomisation methods, blinding, the planning off statistical analyses, calculation of sample size, and possible sources for bias. Methodology for meta-analysis of randomized trials will be described and examples from various medical fields will be discussed. In addition scientific philosophy and ethical aspects will be taught. The randomized clinical trials rank in the hierarchy of evidence is explained from a scientific philosophical view point and seen in connection with the requirements for documentation necessary for taking new technology (in a broad sense) into use. Research ethics, good clinical practice and norms for research will be emphasized. Research ethical principles will be taught and the Helsinki-declaration discussed. Also, examples of research which have not met the ethical standards will be given.

Learning Outcomes

Knowledge

After completing the course, the students should be able to

- explain various aspects when designing and planning randomized trials

- explain methods used in randomization and blinding

- explain methods for meta-analyses of randomized trials

- explain randomized clinical trials¿ place in the hierarchy of evidence, from a scientific theory perspective and related to the requirements for documentation necessary for taking new technology into use

- explain scientific ethical principles and the Helsinki declaration

Skills

After completing the course, the students should be able to

- write and present a written protocol for executing a clinical research project

- plan statistical analyses, calculate sample sizes and evaluate possible errors

- discuss scientific ethical principles and the Helsinki declaration

General skills

After completing the course, the students should

- be familiar with the scientific ethics in clinical/randomized trials

- be responsible for the patient when doing clinical studies

- show respectable behaviour and understand the norms of research

Course offered (semester)

Spring

Pre-requirements

The introductory course in medical statistics (MEDSTA or equivalent) including the fundamental methods use in randomized trials is required. Also, the basic course in medical ethics and philosophy of science (MED1ETIKK or equivalent) is required. Sufficient clinical experience to work with a clinical trial protocol is required. The students will choose the topic for the trial themselves and advised to relate it to psychiatry.

Teaching Methods

The working style of the course is collaboration in groups of size 5-7. Each group will work out at protocol for a randomized clinical trial which will be evaluated by the teachers and presented by the group to the class for discussion. The group work is mandatory and gives knowledge about the protocol as a tool in clinical research and as basis for ethical discussion and approval.

Ordinary lectures in class

Group work under supervision

Presentation and discussion of protocols

4 days a 6 hours

Compulsory Requirements

Group work with concluding protocols for clinical trial are compulsory and should be written during the course week. The protocol should be delivered on third and presented by the group on the last day the same week.

Assessment methods

Passed course requires approval of compulsory written protocol

Grading Scale

Passed/Failed

Reading List

Text book: Petter Laake et al. Epidemiological and clinical research methodology. Gyldendal Akademisk 2007 (spes kap. 9 og 10). All information can be found on the course website. The course requires active use of the library.

Course Unit Evaluation

A course evaluation form will be filled in by each student at the end of the course. The results will be discussed by the lecturers.