Engelsk

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, including 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, 2X2 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.

At the end of the module the student should be able to:

• demonstrate understanding of the principles of clinical and field trials,
• 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
• blinding/masking

Students admitted to a Masters degree or PhD Programme may join this course (e.g. TropEd Europe network). Proficiency in English at a level corresponding to TOEFL 550 or IELTS 6.0 is required.

Physicians and dentists specialising in epidemiology and public health and other health workers and managers who have already acquired basic skills in epidemiology and biostatistics and with special interest in experimental epidemiology (randomised clinical and field trials).

Basic knowledge of epidemiology and biostatistics is required. Applicants are requested to describe their background, including that in epidemiology and biostatistics in their applications.

Each day has a mixture of lectures and practical sessions. The course includes group work on specific topics as well as literature review. Most afternoons are dedicated computer laboratory for sample size estimation and data analysis.

Essential:

1. Lecure notes/slides: Will be uploaded ahead of the copurse

2. Field trials of health interventions in Developing Countries: A toolbox. 2nd. edition. Eds: Smith PG and Morrow RH. Macmillian Press Ltd. ISBN 0-333-64058-6. Can be purchased during course.

Supplementary reading: Rothman K. J. Epidemiology: An Introduction. Oxford University Press. 2002. ISBN 0-19-513554-7