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Course Catalog

340.813.11 Challenges of Clinical Trials in Low and Middle Income Countries

Summer Inst. term
2 credits
Academic Year:
2013 - 2014
East Baltimore
Mon 06/24/2013 - Fri 06/28/2013
Class Times:
  • M Tu W Th F,  1:30 - 5:00pm
Auditors Allowed:
Grading Restriction:
Ayesha Khan
Course Instructor:
Frequency Schedule:
One Year Only

340.645 (introduction to clinical trials) or equivalent course/ work experience


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.

Learning Objectives:

Upon successfully completing this course, students will be able to:

  1. 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
  2. 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)
  3. Choose appropriate study sites based on disease-specific data, knowledge of health systems and counterparts, specific immunological host responses, and genetic variabilities
  4. Interpret, critically appraise, summarize, and disseminate trial results from low-income countries
Methods of Assessment:

20% class participation; 20% in class project: 60% group presentation

Instructor Consent:

No consent required