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, randomization & 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 organization, training & standardization) & 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, randomization & 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:

Knowledge

The student:

• demonstrates understanding of the principles of clinical and field trials,
• explains the principles behind adjustment for repeated measurement of outcomes in the same individuals

Skills

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).

General competence

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.

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.

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.

Student investment time: 125 hours

Lectures 40 hours

Group work and assignments 40 hours

Individual work 45 hours

Written exam

Students who receive the grade "F" are allowed to re-sit according to standard procedures at the University of Bergen.

Centre for International Health

E-mail: mailto:studie@igs.uib.nostudie@igs.uib.no

Tel: 55 58 85 69