Course details

FacultyHealth Sciences
Education levelPostgraduate / Master of Science
Course codeE7Semester2
Course titleClinical Trials
Independent teaching activitiesHours per weekECTS
CoursetypeGeneral setting course, skills development
Prerequisite coursesNone
Teaching and assessment languageEnglish

Learning outcomes


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.


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)

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

  1. Rationale and historical development of clinical trials
  2. Trial phases and designs
  3. Protocol development and resource planning
  4. Compliance with regulatory requirements
  5. Methods of randomization
  6. Allocation concealment and blinding
  7. Ethical issues
  8. Sample size calculation
  9. Data collection instruments and data management
  10. Monitoring trial progress, quality assurance and strategies to boost recruitment
  11. Preparation of statistical analysis plan
  12. Basic principles of statistical analysis
  13. Interpretation of results and dissemination of trial findings

Teaching and learning methods – evaluation

Teaching methodsFace to face
Distance learning
Use of information and
communication technologies (ICT)

  • Use of ICT in Teaching- Moodle Virtual learning environment (VLE)
    (asynchronous learning, wikis, Online Discussion Fora, Educational Portfolio, assignment submission, assessment process)

  • Use of ICT in Communication with students
    (email, instant messaging via Moodle)

Module structureWork Hours per SemesterActivity
Lectures 30
Exercises (Quiz) 5
Exercises (Wikis) 5
Exercises (Online discussion fora) 10
Exercises (Study relevant papers) 20
Essay background work40
Essay writing15
Overall work for the course125
Assessment Methods
  • Written assignment, in English, approximately 2,500 words long, to be submitted by each student at the end of the course
  • Weekly quizes, with multiple choice questions

Recommended Bibliography

  1. Pocock, S. J. (1983). Clinical trials: a practical approach. John Wiley
  2. Friedman, L. M. et al. (2010). Fundamental of clinical trials. Springer