Level of Study
Place of Instruction
Centre for International Health
Objectives and 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)
- 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, including data exploration, baseline comparison, main effects and 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
- 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 size, importing files, data exploration, baseline comparisons, main effects, adjustment for confounding, adjustment for confounding, sub-group analysis and interaction.
On completion of the course the student 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,
- explains the principles behind adjustment for repeated measurement of outcomes in the same individuals
The student is able to:
- 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)
- identify and adjust for any confounding effect (mainly relevant for trials with limited sample size).
The student is able to:
- critically interpret published results from clinical/field trials
- write a competitive research grant proposal for funding of a clinical/field trial.
Required Previous Knowledge
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.
Access to the Course
Students enrolled in the master programme in Global Health, students enrolled in similar programmes at UiB or other partner universities (e.g. tropEd Network for Education in International Health)
Teaching Methods and Extent of Organized Teaching
1+3 weeks, 150 hours:
- Video-based instructions to the course, enrolment on to learning platform and set up of student introduction/presentation on the platform, download of course literature and statistical software, video-based basic introduction to statistical software and pre-reading of introductory material: 20 hours
3 weeks online teaching (130 hours) including:
- Asynchronous studies of web-based lectures (videos, annotated PowerPoint presentations and exercises/quizzes): 50 hours
- Synchronous, moderated web-based sessions including Q&A using chat and plenary discussions and group work using breakout rooms: 20 hours
- Online group work: 20 hours
Self-study and reading during the course: 40 hours
Compulsory Assignments and Attendance
Groups of 4-5 students 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.
Forms of Assessment
Mandatory participation in group work prior to exam.
A 2-hour online written exam, consisting of questions with short answers, problem-solving questions and calculations (60% of the grade). In addition, an oral Zoom-based face-to-face exam of 20 minutes (40% of the grade).
The oral assessment makes it possible to ensure that the student presents his/hers knowledge.
The student fails the exam if less than 40% of the questions are correct.
If the student fails the exam, he/she can re-sit 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 a new exam afterwards
ECTS credits A-E (F=Fail)
The reading list will be made available by 1 December on Mitt UiB
Students evaluate the teaching according to the quality assessment requirements of the University of Bergen. The evaluation method is through an online electronic form.
The Department of Global Public Health and Primary Care
Centre for International Health
Tel: 55 58 85 69