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Design and Conduct of Community Trials

East Baltimore
3rd term
International Health
4 credits
Academic Year:
2022 - 2023
Instruction Method:
Class Times:
  • Tu Th,  1:30 - 3:20pm
Auditors Allowed:
Yes, with instructor consent
Undergrads Allowed:
Grading Restriction:
Letter Grade or Pass/Fail
Course Instructors:
Joanne Katz

Biostatistics 620 series or higher, and Epidemiology Methods or Professional Epidemiology courses recommended but not required


Field trials in low-income countries are needed to assess potentially useful new interventions and to develop more effective disease control strategies.

Helps students (1) critically review the community trials literature, and (2) develop, identify and justify a randomized community trial design appropriate to answer a set of specific research aims. Discusses different types of randomized study designs appropriate for community (as opposed to clinical) trials. Includes topics: critical review of the community trials literature, formulation of specific aims, selection of study designs and appropriate study populations, estimation of sample size, methods for allocation of interventions or treatments, grantsmanship and budgeting, community participation, consent procedures, ethical and cultural considerations, specification of key outcomes, Safety and Monitoring Boards, data management, analyses and publication of results. Applies these methods in many settings, but emphasizes issues that are unique to developing country and resource constrained environments.

Learning Objectives:

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

  1. Formulate a research question and design a trial
  2. Describe the methods used to conduct a trial, and the types of data analysis required to answer the research question
  3. Design epidemiologic studies to define and measure public health problems in low-resource settings including the design, ethical considerations, and implementation of the studies
  4. Design a community trial that answers a relevant quantitative research question of concern to disadvantaged populations
Methods of Assessment:

This course is evaluated as follows:

  • 40% Group Project(s)
  • 5% Participation
  • 20% Homework
  • 30% Written Assignment(s)
  • 5% Interim Assessment

Instructor Consent:

No consent required