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2007 Course in Clinical Trials Methods
ACS Headquarters and the Wyndham Hotel
Chicago, IL
November 9-13, 2007
Preliminary Course Schedule
Day 1 - Friday, November 9, 2007
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4:00 - 5:00 pm
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Lecture # 1: Overview of design options for clinical trials; types of clinical research (prospective, retrospective, observational, randomized clinical trials, administrative databases, meta-analysis); and issues unique to surgical trials
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| 5:00 - 6:00 pm |
Lecture # 2: The Question and End Points
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6:15 – 7:30 pm
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Group Reception
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Day 2 - Saturday, November 10, 2007
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7:00 - 8:00 am
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Breakfast
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| 8:00 - 9:00 am |
Lecture #3: Patient Selection—selecting, recruiting, and retaining subjects; sampling strategies and external validity inclusion/ exclusion criteria, stratification, impact of managed care and problems with accrual
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| 9:00 - 10:00 am |
Lecture #4: Experimental Design for a Randomized Clinical Trial— techniques of randomization, stratification |
| 10:30 am - 12:00 pm |
Breakout: Begin the process of topic/alternate topic selection |
| 12:00 - 1:00 pm |
Lunch |
| 1:00 - 2:00 pm |
Lecture #5: Interventions |
| 2:00 - 3:00 pm |
Lecture #6: Sample Size, Statistical Inference, and Hypothesis Testing
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| 3:00 - 5:30 pm |
Breakout: Complete topic selection, conduct literature search |
| 6:30 - 8:00 pm |
Group Dinner |
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Day 3 - Sunday, November 11, 2007
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7:00 - 8:00 am
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Breakfast
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| 8:00 - 9:00 am |
Lecture #7: Statistical Concepts in Clinical Trials: rationale for randomized trials, statistical testing, factorial designs, intent to treat analysis, large sample trials, meta-analyses.
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| 9:00 - 10:00 am |
Lecture #8: Publication of Results |
| 10:00 - 10:30 am |
Coffee Break
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| 10:30 - 11:30 am |
Lecture #9: Ethics of Clinical Trials |
| 11:30 - 12:30 pm |
Lecture #10: Clinical Trials Methods Analysis: statistical methods, tests of significance, intention to treat, multiple end points, repeated measurements, subgroup analysis, crossover problems |
| 12:30 - 1:30 pm |
Lunch
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| 1:30 - 5:30 pm |
Breakout: Work with sample size software, begin to outline proposal
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Day 4 - Monday, November 12, 2007
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7:00 - 8:00 am
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Breakfast
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| 8:00 - 9:00 am |
Lecture #11: Funding Sources |
| 9:00 - 10:00 am |
Lecture #12: Trial Management and Planning Measurements |
| 10:00 - 11:00 am |
Lecture #13: Mistakes in Clinical Trials |
| 11:00 - 5:30pm |
Breakout: Complete and distribute proposal |
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Day 5 -Tuesday, November 13, 2007
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6:00 - 7:00 am
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Breakfast
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| 7:00 am - 12:00 pm |
Presentations: Presentation of proposals from individual groups.
Discussion and scoring after each presentation
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| 12:00 - 1:00 pm |
Wrap-up and Conclusions
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Revised June 27, 2008
Surgical Research Committee
This page and all contents are Copyright © 1996-2008
by the American College of Surgeons, Chicago, IL 60611-3211
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