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EPID 5514

Community Clinical Trials

3 Credits · Level: Graduate, Undergraduate

Community-Based Clinical Trials Course description Community-based clinical trials are randomized experiments to measure the effect of an intervention outside of a healthcare setting. Such trials provide valuable evidence to inform policies and programs that impact health and other aspects of well-being. This course covers history, theory, and practical considerations for community-based trials. Students will leave the course better equipped to design a trial, and to critique the scientific literature. Readings will cover important trials for health and health equity in the US and abroad. Course objectives 1. Summarize the history of community-based trials and describe the role they play in evaluation of health interventions; 2. Explain the key differences, advantages and disadvantages of experimental versus observational study designs; 3. Develop a protocol, consent statement, monitoring plan and data collection plan for a clinical trial; 4. Review and critique manuscripts presenting the results of community-based trials using CONSORT guidelines; and 5. Explain the key ethical principles regarding the design, conduct and analysis of clinical trials

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