Course content

The Unit for Applied Clinical Research, NTNU Trondheim is holding a 5-day course on clinical research. Partly English syllabus.

The first part is a 3-day course on Randomised Controlled Trials (RCTs). This course will cover all aspects of RCTs, from design to reporting. Particular emphasis will be placed upon practical aspects. Recent advances in RCT methodology will be covered, including data monitoring committees (DMCs), sample size estimation, stopping rules, ethical review procedures (IRBs), good clinical practice (GCP is increasingly demanded as a standard by the European Union), and reporting of trials (Revised CONSORT Statement, Annals of Internal Medicine, 2001).
• Background, including non-randomised studies and historical controls. Controlled trials; placebos; double blind; multicentre trials; phase I, II, III IV trials; cross-over trials; equivalence trials.
• Randomisation, and how to implement it; cases of failed randomisation; is randomisation ethical? The uncertainty principle. Patient consent.
• Protocol design: Background, eligibility criteria, randomisation, sample size, outcome measures, procedures for participants, monitoring, reporting and analysis, publication policy.
• Form design and layout.
• Basic statistics: Significance tests, confidence intervals and p-values.
• Sample size estimation: Methods and application, demonstration of program SAMPLE SIZE
• Approval and procedures: Writing committees, protocol review procedures, ethical approval (IRB), Data Monitoring Committees (DMC)
• Statistical aspects of data monitoring: Data monitoring - role and methods, recruitment charts, interim analyses, stopping rules and examples of trials which were stopped prematurely. Bayesian monitoring.
• Organisational aspects: Multicentre trials; structure of trials offices; training of staff; launch of trials; data entry; data management; monitoring procedures; data checking - double data entry.
• Analysis: Patient exclusions; intention to treat analysis; pragmatic or exploratory analyses; data checking; significance tests; equivalence trials; multiple endpoints.
• Conflicts of interest. Fraud, bias and confounding.
• Reporting: Eligibility; patient exclusions; standard journal requirements; reporting randomisation procedures; interpreting significance; clinically significant effects; confirmatory trials; BMJ checklist.

The second part of the course (2 days) 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. How to design, use, analyse and interpret the results from cross-sectional-, case-control-, and cohort studies; and the strengths and limits of these designs in a clinical setting. How to establish, maintain and use clinical registers and databases and to differentiate such registers from epidemiological/population based surveys and data in medical records.

Learning outcome

The student shall learn to evaluate clinical measure methods and diagnostic tests, including design, organisation, carrying out and reporting clinical studies. The main focus is on the randomized controlled clinical experiment.

Learning methods and activities

Lectures, group work, home assignment.

Compulsory assignments

• Paper/excercise before written exam
• All lectures

Recommended previous knowledge

No specific previous knowledge other than 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, epidemology 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 (third edition)
Forlag: Lippincott Williams & Wilkins: 2007. ISBN-13: 978-0-7817-8210-4. ISBN-10: 0-7817-8210-4.
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