Syllabus - 2011 Course Syllabus PubH 7-420 Credits: 3...

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PubH 7-420 Credits: 3 Meeting Days: TTh Meeting Time: 9:45-11:00AM Meeting Place: Hasselmo Hall 2-101 Instructor: Jim Neaton Office Address: 2221 University Ave SE, Room 200 Office Phone: (612) 626-9040 Fax: (612) 624-2819 E-mail: jim@ccbr.umn.edu Office Hours: By appointment TA’s: Xiting Cao (caoxx060@umn.edu) and Rajarshi Guha Niyogi (guhan003@umn.edu) I. Course Description Clinical Trials: Design, Implementation and Analysis II. Course Prerequisites Introduction to Biostatistics III. Course Goals and Objectives 1. Identify basic characteristics of a clinical trial and describe the advantages and disadvantages or randomized clinical trials as compared to other epidemiological and clinical investigations. 2. Construct randomization schedules and develop procedures for carrying out randomization and blinding. 3. Determine when pre-stratified designs should be used and to differentiate pre from post- stratification. 4. Recommend appropriate experimental designs for addressing medical/public health questions and understand the advantages and disadvantages of different study designs. 5. Identify the advantages and disadvantages of different endpoints for trials. 6. Recognize the regression to the mean phenomenon and how to minimize its effect. 7. Discuss examples of misconduct and fraud and their implications in clinical research. 8. Determine sample sizes for trials of simple design and understand ingredients in the sample size determination for more complex designs. 9. Write the statistical design and data analysis section of a protocol and identify special requirements of collaborative trials, their organization and operation. 10. Determine the data collection requirements and quality assurance procedures for clinical trials. 11. Understand the advantages of intent-to-treat analysis and to differentiate it from an on treatment analyses. 1
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Syllabus - 2011 Course Syllabus PubH 7-420 Credits: 3...

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