340.813.11 CHALLENGES OF CLINICAL TRIALS IN LOW AND MIDDLE INCOME COUNTRIES
June 24-28, 2013
1:30 p.m. – 5:00 p.m.
While the methodology of randomized clinical trial (RCT) design does not differ according to geographical region, several considerations must be taken into account when planning trials in low-income countries, such as clinical practice differences between countries/regions, differences in the composition of the study population, availability of diagnostic and therapeutic means, and regulatory differences. At the same time, some low-income countries offer the possibility to run a clinical trial for less than 20% of the price of a trial in the US. Students are offered a toolbox for researchers to address the differences and difficulties of research in low-income countries, in particular RCTs.
Topics covered include: types of clinical trials and their methodological challenges revisited; hot topics for research in low-income countries, for example the evaluation of practice guidelines under the conditions in low-income countries; community engagement in clinical trials.
Student Evaluation: 20% class participation; 20% in class project: 60% group presentation
Learning Objective: Upon successfully completing this course, students will be able to
- Discuss different trial designs and their advantages and disadvantages with respect to the scientific study question and the setting in which the study takes place
- Describe address important challenges posed to trialists in low-income settings when planning a trial (for example vulnerable populations, asymmetric communication with local counterparts and regulatory authorities, and infrastructural restraints)
- Choose appropriate study sites based on disease-specific data, knowledge of health systems and counterparts, specific immunological host responses, and genetic variabilities
- Interpret, critically appraise, summarize, and disseminate trial results from low-income countries�
Class Times: Mon 06/24/2013 - Fri 06/28/2013
·Monday 1:30 - 5:00
·Tuesday 1:30 - 5:00
·Wednesday 1:30 - 5:00
·Thursday 1:30 - 5:00
·Friday 1:30 - 5:00
Prerequisite: 340.645 (introduction to clinical trials) or equivalent course/ work experience
Grading Options: Pass/Fail
Course Materials: Provided in class and through CoursePlus