CHALLENGES OF CLINICAL TRIALS IN LOW AND MIDDLE INCOME COUNTRIES Syllabus
Course 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
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.
JHSPH students and Summer Institute participants
Methods of Assessment
Grading Policy: 20% class participation; 20% in class project: 60% group presentation
Grading Restrictions: Pass and Fail
340.645 (introduction to clinical trials) or equivalent course/ work experience
Academic Ethics Code
The code, discussed in the Policy and Procedure Memorandum for Students, March 31, 2002, will be adhered to in this class:
Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.
Disability Support Services
If you are a student with a documented disability who requires an academic accommodation, please contact Betty H. Addison in the Office of Student Life Services: firstname.lastname@example.org, 410-955-3034, or 2017 E. Monument Street.