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Course Catalog

223.664.01 DESIGN AND CONDUCT OF COMMUNITY TRIALS

Department:
International Health
Term:
3rd term
Credits:
4 credits
Academic Year:
2014 - 2015
Location:
East Baltimore
Class Times:
  • Tu Th,  1:30 - 3:20pm
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Contact:
Joanne Katz
Course Instructors:

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Prerequisite:

140.621, 140.622, 140.623 concurrently, or 140.651-653, 340.602 or 340.608 highly recommended but not required

Description:

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. Topics include 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. These methods apply 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
Methods of Assessment:

Student evaluation based on exercises, oral presentations and a group project (proposal to conduct a community based randomized trial).

Student grades will be based on specific aims for group project (5%), a sample size exercise (10%), a draft consent form (15%), a written literature critique (20%), one oral presentations (5%), attendance at the final group presentations (5%), and a group project (40%).

Instructor Consent:

No consent required