Language of instruction
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, for instance HIV infection, diarrhoea and pneumonia. 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, interpretation of negative trials and ethical aspects of clinical trials in developing 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.
The schedule for the course can be found here: http://www.uib.no/en/course/INTH321A.
On completion of the course the PhD-candidate should have the following learning outcomes defined in terms of knowledge, skills and general competence:
- Demonstrates understanding of the principles of clinical and field trials,
- Understands the principles behind adjustment for repeated measurement of outcomes in the same individuals
- Understands pros and cons with alternative trial designs such as step-wedge design
The PhD-candidate is able to:
- Genuinely contribute to the planning and conduct 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, conduct: sample size estimations, random allocation and blinding/masking
- Analyze clinical and field trial data-sets, also from community-randomized trials
- Identify interaction (in trials with stratified as well as un-stratified randomization)
- Be able to identify and adjust for any confounding effect (mainly relevant for trials with limited sample size).
The PhD-candidate is able to:
- Critically interpret published results from clinical/field trials, write a competitive research grant proposal for funding of a clinical/field trial.
Proficiency in English at a level corresponding to TOEFL 550 (paper-based) or 213 (computer-based) or IELTS band 6.0 is expected.
It is also a requirement to have knowledge of basic epidemiology and biostatistics, and the applicants should describe their background, including that in epidemiology and biostatistics in their applications. Certificates from biostatistics and epidemiology courses and workshops should be submitted along with the applications.
Groups of 4-5 students/candidates work together on a research grant proposal for funding of a clinical/field trial. Documented contribution to this proposal, which is presented in a plenary session is a prerequisite for taking the course examination.
Form of assessment
Written exam. Examination Support Material: Dictionary, calculator
Home assignments with 1/ Analysis of a data set 2/ Present a critical review of a published paper.
Grading Scale: ECTS credits A-F (F=fail)
Who may participate
Candidates admitted to a PhD Programme may join this course (e.g. tropEd network). Priority will be given to candidates from the a) University of Bergen, b) candidates on collaborative projects with UiB, c) candidates from other Norwegian Universities through the Norwegian Research School of Global Health.
Supplementary course information
Daily sessions. Each day has a mixture of lectures and practical sessions including computer lab sessions. The course includes group work on specific topics as well as literature review .
Course Coordinator:Thorkild Tylleskär
Course Administrator: Centre for International Health, Department of Global Public Health and Primary Care
Tel: 55 58 85 69
Lecture notes and handouts.
ICH. Integrated addendum to ICH E6(R1): Guideline for good clinical practice. E6(R2)
Current Step 2 version, dated 11 June 2015
Peter G. Smith, Richard H. Morrow, and David A. Ross (eds). Field trials of health interventions A Toolbox, 3rd ed. 2015. Paperback 480 pages, ISBN 978 0 19 873286 0
Available as: eBook Download from:
Parts of this book:
WHO. WHO Handbook for guideline development. 2nd ed. 2014. Paperback 170 p. ISBN 978 92 4 154896 0. Available as eBook Download from: http://www.who.int/kms/handbook_2nd_ed.pdf