Title: Experimental Epidemiology
Keywords: Statistics (incl.. risk assessment)
Research method
Quantitative methods
Planning and programming (incl.. budgeting and evaluation)
Epidemiology
Country: Norway
Institution: Norway - Centre for International Health, Universitetet i Bergen
Course coordinator: Thorkild Tylleskär
Date start: 2018-02-26
Date end: 2018-03-16
About duration and dates: three weeks (45 hours per week) and 10 hours of pre-reading
Classification: advanced optional
Mode of delivery: Face to face
Course location: Centre for International Health, Bergen
ECTS credit points: 5 ECTS credits
SIT: 145 hours: 75 hrs direct contact hours, 30 group work and lab work, 10 hours of pre reading and 26 individual study hours during the course, 4 hours exam
Language: English
Description:
At the end of the module the student should be able to:
• Discuss the principles of clinical and field trials,
• contribute to planning of 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 the 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 select relevant designs for clinical/field trials,
- For both individually and community-randomized trials, estimate sample sizes of studies and plan and conduct random allocation of persons in groups and
- blinding/masking of examinations
• analyse clinical and field trial data-sets, also from community-randomised trials
Assessment Procedures:
Mandatory participation in group work prior to exam. A 4-hour written exam consisting of short questions and problem-solving questions and calculation. 50% of the grading will be from the answers to the short questions and 50% will be based on the problem-solving task.
If the student fails to pass the exam, the student will be allowed to resit for a new exam in the same semester.
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 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 size, importing files, data exploration, baseline comparisons, main effects, adjustment for confounding, adjustment for confounding, sub-group analysis and interaction.
Methods:
Daily sessions. Each day has a mixture of lectures and practical sessions (e.g. validation/standardisation session of measures like height and weight) including group work and computer lab sessions. The course includes group work on specific topics as well as literature review.

All course material is available on the University’s learning platform called “MittUiB”, which is based on Canvas.
Prerequisites:
Students admitted to a Master’s degree Programme may join this course (e.g. TropEd Europe 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.
Attendance:
Compulsory 80% attendance of group work and practical exercises.
Max no of students: 30 (max 15 from TropEd network).
Min. no of students: 5.
Selection: The selection will be based on documented skills in epidemiology and biostatistics.
Fees: 70 EUR for tropEd students
Major changes since initial accreditation:
Based on student evaluations, the course has been extended to a 3-weeks course, to allow for more time to cover the content. We have added focus on Good Clinical Practice.
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 to 3 weeks. 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, in October 2011 and in January 2017. This accreditation is valid until January 2022.
Remarks:
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

ICH. Integrated addendum to ICH E6(R1): Guideline for good clinical practice. E6(R2)
Current Step 2 version, dated 11 June 2015
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Prod
ucts/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2.pdf

To Application Form
Email Address: Linda.Forshaw@uib.no
Date Of Record Creation: 2012-01-13 01:19:11 (W3C-DTF)
Date Of Record Release: 2014-10-10 09:26:39 (W3C-DTF)
Date Record Checked: 2017-09-12 (W3C-DTF)
Date Last Modified: 2017-10-10 04:45:03 (W3C-DTF)

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