Course details
General
Faculty | Health Sciences | ||
Department | Medicine | ||
Education level | Postgraduate / Master of Science | ||
Course code | E7 | Semester | 2 |
Course title | Clinical Trials | ||
Independent teaching activities | Hours per week | ECTS | |
Lectures | 1 | ||
Practice | 3 | ||
Total | 4 | 4 | |
Coursetype | General setting course, skills development | ||
Prerequisite courses | None | ||
Teaching and assessment language | English |
Learning outcomes
Objective
This course will introduce students to the fundamentals of design and conduct of clinical trials. The course will cover all stages of interventional studies in humans ranging from protocol development and regulatory issues to participant recruitment, data collection and statistical analysis. By the end of the course, students will be able to consider all practicalities of trial conduct from the perspective of a potential lead investigator.
Knowledge
Upon completion of the course, graduate students will be familiar with:
- Regulatory framework covering interventional studies in humans
- Ethical issues and dilemmas that are unique to clinical trials
- Varying clinical trial designs (i.e. dose-finding, parallel, factorial, cross-over)
- Different randomization schemes
- Techniques for effective implementation of allocation concealment and blinding
- Relevant statistical issues (superiority, non-inferiority and equivalence trials, approaches to handling of missing data, survival analysis)
Skills
The course participants upon completion will be able to:
- Formulate a clear question for a randomized trial
- Carry out sample size calculations
- Design data collection forms using appropriate electronic data management tools
- Prepare a statistical analysis plan for a randomized trial
- Produce a comprehensive clinical study report and disseminate study findings
Course contents
- Rationale and historical development of clinical trials
- Trial phases and designs
- Protocol development and resource planning
- Compliance with regulatory requirements
- Methods of randomization
- Allocation concealment and blinding
- Ethical issues
- Sample size calculation
- Data collection instruments and data management
- Monitoring trial progress, quality assurance and strategies to boost recruitment
- Preparation of statistical analysis plan
- Basic principles of statistical analysis
- Interpretation of results and dissemination of trial findings
Teaching and learning methods – evaluation
Teaching methods | Face to face Distance learning |
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Use of information and communication technologies (ICT) |
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Module structure | Work Hours per Semester | Activity |
Lectures | 30 | |
Exercises (Quiz) | 5 | |
Exercises (Wikis) | 5 | |
Exercises (Online discussion fora) | 10 | |
Exercises (Study relevant papers) | 20 | |
Essay background work | 40 | |
Essay writing | 15 | |
Overall work for the course | 125 | |
Assessment Methods |
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Recommended Bibliography
- Pocock, S. J. (1983). Clinical trials: a practical approach. John Wiley
- Friedman, L. M. et al. (2010). Fundamental of clinical trials. Springer