Title: Experimental epidemiology (will not take place in 2021)
Keywords: Statistics (incl.. risk assessment)
Research (in general)
Quantitative methods
Planning and programming (incl.. budgeting and evaluation)
Country: Norway
Institution: Norway - Centre for International Health, Universitetet i Bergen
Course coordinator: Thorkild Tylleskär
About duration and dates: 4 weeks in total: 1-week self-study: TBD 3-weeks interactive course: TBD
Classification: advanced optional
Mode of delivery: Distance-based
Course location: On campus, Centre for International Health, Arstadveien 21, University of Bergen, Bergen, Norway
ECTS credit points: 5 ECTS credits
SIT: 1+3 weeks, 150 hours:
a) 20 hours of preparations during the self-study week including: video-based course instructions, log-in to learning platform and student introduction/presentation on the platform, download of course literature and install statistical software, complete video-based basic introduction to statistical software and pre-reading of introductory materials.
b) On campus 3 weeks (130 hours): 60 hrs direct contact hours, 20 hours group work, 10 hours computer lab work, 40 hours self-studies during the course
Language: English
Description: At the end of the module the student should be able to:
• Demonstrate understanding of the principles of clinical and field trials,
• Plan clinical and field trails in accordance with the EU Directive 2001/20/EC on Good Clinical Practice and the highest ethical principles, including those reflected in Article 6 of the Treaty on European Union, in the Charter of Fundamental Rights of the European Union and the Council of Europa’s Convention on Human Rights and Biomedicine,
• Assess and identify relevant designs for clinical/field trials,

• For both individually and community-randomized trials, understand and demonstrate the procedure of:
- sample size estimations
- random allocation
- blinding/masking
• Analyse clinical and field trial datasets, including from community-randomised trials
Assessment Procedures: Mandatory participation in group work prior to exam.
A 4-hour written exam consisting of questions with short answers, problem-solving questions and calculations.
ECTS Grading scale A-F
If the student fails the exam, he/she can resit for exam in the same semester. If the student fails a second time, he/she will be advised to participate in the course one more time in the next year and has to sit a new exam afterwards.
Content: This course addresses critical methodological aspects of clinical and field trials and a special effort is made to address trials that will measure the impact of relevant interventions against poverty-related diseases in low-resource settings.

The lectures in the course cover the following: General principles of field trials, literature review: what & how to read, randomisation & blinding, review of basic statistics (Mean, SD, SE, 95%CI), proportions, 2 x 2 tables, trial size for adequate precision and power, cluster design, data management and study implementation, interaction & confounding, effect measures (Risk ratio, rate ratio, difference in means), relative risk reduction, measurement: validity & reproducibility, analysis plan, data exploration, baseline comparison, main effects, analysis of community-based studies, hypothesis tests & precision of effect, analysis of repeated outcomes, data collection (questionnaire design, field organisation, training & standardisation) & quality control, good clinical practice (GCP), interpretation of negative trials and ethical aspects of clinical trials in low-income countries.

The group work covers a) the analysis of a published trial, b) the development of proposal and protocol, the structure of baseline and main effect tables, randomisation & blinding.

The computer laboratory exercises include generating random numbers, calculating trial sizes, importing files, data exploration, baseline comparisons, main effects, adjustment for confounding, sub-group analysis and interaction.
Methods: Daily sessions. Each day has a mixture of lectures and practical sessions including group work and computer lab sessions. The course includes group work on specific topics as well as literature review.

All course materials are available on the University’s learning platform called “Mitt UiB”, a Canvas-based platform.
Prerequisites: Students admitted to a master’s degree programme may join this course (e.g. tropEd network).

Proficiency in English at a level corresponding to TOEFL score of at least 550 points paper-based or 213 points computer-based, or an equivalent approved test.
Completed a course in Basic introduction to Methods in Global Health Research or equivalent.
Attendance: A minimum of 10 students is needed to run the course, and a maximum of 50 students (max. number of tropEd students: 20)
Selection: The selection will be based on documented skills in epidemiology and biostatistics.
Priority will be given to
Master students in Global Health enrolled at the University of Bergen and Master students from institutions within tropEd.
If needed, first come, first served.
Fees: A semester fee to the student union of around 500 NOK = 55 Euro
Scholarships: None from the University of Bergen
Major changes since initial accreditation: Updated the content to current requirements of clinical trials.
Student evaluation: The feedback from the students has consistently been that they are very content with the course and its content, but that it is still a dense course, even after extending it. We stress that the students should have prior knowledge of epidemiology and biostatistics.
Lessons learned: The course prepares the students for running a clinical trial in a low resource setting. Without solid knowledge in epidemiology and biostatistics, the students find the course tough.
tropEd accreditation: Accredited in Copenhagen 2003, Re-accreditation in Edinburgh, September 2004. Re-accreditation in London, September 2009 and in October 2011. Re-accredited in January 2017. This accreditation is valid until October 2022.
Remarks: Course literature:
Peter G. Smith, Richard H. Morrow, and David A. Ross (Eds),
Field Trials of Health Interventions – A Toolbox,
Oxford University Press, Oxford, 3rd Ed, 2015.
Freely downloadable from:
2. ICH harmonised tripartite guideline: Guideline for good clinical practice E6. Downloadable from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf
3. WHO. Handbook for guideline development. 2nd ed. WHO 2014. Downloadable from: http://apps.who.int/iris/bitstream/10665/75146/1/9789241548441_eng.pdf?ua=1
4. Welch, V. A., et al. (2017). "CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials." BMJ 359: j5085. Downloadable from:
Date Of Record Creation: 2020-11-04 07:37:14 (W3C-DTF)
Date Of Record Release: 2020-11-04 13:46:07 (W3C-DTF)
Date Record Checked: 2020-11-04 (W3C-DTF)
Date Last Modified: 2020-12-07 10:05:23 (W3C-DTF)

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