Examination arrangement

Course content

The course consists of three parts, 3 + 2 + 2 days, usually in the beginning of September, October and November. The course is focusing on Randomized Controlled Trials (RCTs) and will cover all the important aspects of RCTs, from design to reporting. Particular emphasis will also be placed upon practical aspects. Recent advances in RCT methodology will be covered. Other research designs will also be presented with focus on strengths and limitations. Protocol design will be covered with focus on background, eligibility criteria, randomization, sample size, outcome measures, procedures for participants, monitoring, reporting and analysis, and publication policy. A short introduction/repetition of basic statistics will focus on significance tests, confidence intervals, p-values and sample size estimation. Fraud, bias and confounding will be discussed. The course also covers the use of clinical measurements and studies on diagnostic tests, including precision, accuracy, validity, specificity, sensitivity, reproducibility, feasibility, appropriateness and how to interpret the results in a clinical setting. Further, the course will focus on Patient Reported Outcomes (PRO). Worldwide there is an increasing demand to always consider measurements of PRO in new clinical trials. Measurements of PRO and subjective symptoms are generally important, but particularly important in studies of palliative care. The course will cover several aspects of these measurements in randomized studies and clinical trials; choice of questionnaire, methods, study design, problem solving, analysis and comprehension of the data, report of results and conclusions. The course will also focus on how to read and interpret papers with focus on how to evaluate the scientific quality, i.e. should the results be trusted or not. An important part of this is homework with a written evaluation of selected papers. Having taken the course participants should be able to evaluate the work of others as well as to plan, execute and report their own clinical studies according the highest scientific standards.

Learning outcome

After completing the course, the student is:

• Able to assess the expediency and application of the different designs in clinical research including more sophisticated designs. Major focus will be on randomized controlled trials (RTC)
• Able to contribute to the improvement of designs and methods in clinical research
• By a given hypothesis able to formulate research questions in accordance with the different types of design
• With the correct methods able to design, implement, analyze and publish clinical research on an international level
• Able to identify research questions related to design and carry out research with a methodical integrity
• Able to communicate clinical research and development through acknowledged national and international channels
• Able to select and use methods of patient reported outcome
• Able to evaluate the quality of clinical research papers

Learning methods and activities

Lectures, group work, home assignment. To be allowed to take the examination all homework must be delivered on time and at least 80% attendance of the lectures is mandatory.

Compulsory assignments

• Paper/excercise before written exam
• All lectures

Further on evaluation

If retake of the examination this can be either by a written or an oral test. This is to be deceided by the person responsible for the course.

Specific conditions

Recommended previous knowledge

Master's degree knowledge within the field of health sciences or medicine. If you do not have a medical background you are recommended to attend a course on clinical science, epidemiology or statistics on a master degree level.

Required previous knowledge

Master degree or similar. Medical students at The Student Research Programme. Candidates with a lower degree will be assessed individually.

Course materials

Stephen B Hulley et al. Designing Clinical Research (fourth edition) Forlag: Lippincott Williams & Wilkins: 2013. ISBN: 978-1-60831-804-9. David Machin & Peter Fayers. Randomized controlled trials. Design, practice and reporting. Forlag: Wiley-Blackwell 2009/2010. ISBN-10: 0471498122. ISBN-13: 978-0471498124.

Credit reductions