340.813.11
Challenges of Clinical Trials in Low and Middle income Countries
Location
East Baltimore
Term
Summer Institute
Department
Epidemiology
Credit(s)
2
Academic Year
2013 - 2014
Instruction Method
TBD
Start Date
Monday, June 24, 2013
End Date
Friday, June 28, 2013
M, Tu, W, Th, F, 1:30 - 5:00pm
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
One Year Only
Resources
Prerequisite
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:
- 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