| Title: |
Experimental Epidemiology |
| Keywords: |
Statistics
Research
Quantitative methods
Planning and programming
Epidemiology
|
| Country: |
Norway
|
| Institution: |
Norway - Centre for International Health, Universitetet i Bergen
|
| Course coordinator: |
Thorkild Tylleskär
|
| Date start: |
2026-02-02 |
| Date end: |
2026-02-20 |
| About duration and dates: |
3.5 weeks in total: ½-week self-study 3-weeks interactive course Application deadline: 1 November 2025 |
| Classification: |
advanced optional
|
| Mode of delivery: |
Face to face
|
Course location:
On campus, Centre for International Health, Arstadveien 21,
University of Bergen, Bergen, Norway |
|
| ECTS credit points: |
5 ECTS credits
|
SIT:
150 hours:
a) 15 hours of preparations during one self-study week including: course instructions, log-in to learning platform and student introduction/presentation on the platform, download of course literature and install statistical software, and pre-reading of introductory materials.
b) On campus 3 weeks (135 hours): 60 hrs direct contact hours, 20 hours group work, 10 hours computer lab work, 45 hours self-studies during the course |
|
| Language: |
English
|
Description:
At the end of the module the student should be able to:
● Discuss the principles of clinical and field trials,
● Plan clinical and field trials in accordance with the EU Directive 2001/20/EC on Good Clinical Practice and the highest ethical principles.
● Assess and identify relevant designs for clinical and 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 (not graded) 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
Exam on the last day of the course.
The student fails the exam if less than 40% of the questions are correct.
If the student fails the exam, he/she can resit for the 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 sit for 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 and practicals in the course cover the following:
1st week:
* General principles of field trials (4 hours)
* PICO (Population, Intervention, Comparator, Outcome)
(4 hours)
* Good clinical practice (GCP) (4 hours)
* Literature review: what & how to read (1 hour)
* Randomisation & blinding (4 hours)
* Review of some basic statistics, and interaction, confounding,
validity & reproducibility and effect measures (Risk ratio,
rate ratio, difference in means) in relation to clinical trials
(6 hours)
* Relative risk reduction (2 hours)
* Trial size for adequate precision and power (4 hours)
2nd week:
* Cluster design (4 hours)
* Data management and study implementation (4 hours)
* Analysis plan, including data exploration, baseline
comparison, main effects and analysis of community-based
studies (4 hours)
* Hypothesis tests & precision of effect (4 hours)
* Analysis of repeated outcomes (4 hours)
* Data collection (questionnaire design, field organisation,
training & standardisation) & quality control (8 hours)
* Interpretation of negative trials (2 hours)
* Ethical aspects of clinical trials in low-income countries (4
hours).
3rd week:
2 full day presentations of group works
2 reading days
1 exam day |
|
Methods:
Daily sessions for two weeks. Each morning lectures and each afternoon practical sessions including group work and computer exercises. Approximately 50-50 of each.
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 exercises include generating random numbers, calculating trial sizes, importing files, data exploration, baseline comparisons, main effects, adjustment for confounding, sub-group analysis and interaction (not graded).
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.
Completed the 2-credit course Medical Statistics with Stata (MEDSTATA) https://www4.uib.no/en/studies/courses/medstata 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:
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, we use the principle ‘first come, first served’ |
|
|
|
|
Scholarships:
None available 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. |
|
Lessons learned:
Without solid knowledge in epidemiology and biostatistics, the students find the course tough. |
|
tropEd accreditation:
This is a new course – online version -, but has the same content as an on campus course which was:
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. Re-accredited October 2020. Re accredited in EC Telco, Dec. 2025. The accreditation is valid until December 2030 |
|
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:
http://ieaweb.org/wp-content/uploads/2015/07/Field-trials-of-health-interventions-a-toolbox-with-full-hyperlinks-July-15.pdf
or
http://www.oapen.org/download?type=document&docid=569923
2. ICH harmonised guideline: Guideline for good clinical practice E6 (R3). Downloadable from: https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf
3. WHO. Handbook for guideline development. 2nd ed. WHO 2014. Downloadable from: https://www.who.int/publications/i/item/9789241548960
4. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ 2025;389:e081123 Downloadable from:
https://www.bmj.com/content/389/bmj-2024-081123
5. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ 2025;389:e081477 Downloadable from: https://doi.org/10.1136/bmj-2024-081477 |
|
| Email Address: |
Linda.Forshaw@uib.no |
| Date Of Record Creation: |
2012-01-13 01:19:11 (W3C-DTF) |
| Date Of Record Release: |
2022-10-11 10:18:32 (W3C-DTF) |
| Date Record Checked: |
2021-12-09 (W3C-DTF) |
| Date Last Modified: |
2025-12-16 09:30:55 (W3C-DTF) |
