223.664.01 DESIGN AND CONDUCT OF COMMUNITY TRIALS

Helps students (1) critically review the community trials literature, (2) develop, identify and justify a randomized community trial design appropriate to answer a set of specific research aims. Different types of randomized study designs appropriate for community (as opposed to clinical) trials are discussed. 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 analyses and publication of results. These methods apply in many settings, but emphasis is placed on issues that are unique to developing country environments.

At the end of this course, you should be able to: 1) formulate a research question and design a trial; and 2) describe the methods used to conduct a trial, and the types of data analysis required to answer the research question.