ACS Headquarters and the Wyndham Hotel
Chicago, IL
November 13–17, 2009

Preliminary Course Schedule

Day 1 | Day 2 | Day 3 | Day 4 | Day 5

Day 1—Friday, November 13, 2009

7:00–8:00 am	Breakfast
8:00–9:30 am	Kamal M. F. Itani, MD, FACS—Review of Four Clinical Trials (pre-assigned reading)
9:30–10:30 am	William G. Henderson, PhD—Statistics 1
10:30–11:00 am	Coffee Break
11:00 am–12:00 pm	Domenic Reda, PhD—Statistics 2
12:00–1:00 pm	Lunch
1:00–2:00 pm	Lecture #1: Mary T. Hawn, MD, FACS—Overview of Design Options for Clinical Trials: Types of clinical research (prospective, retrospective, observational, and randomized clinical trials; administrative databases; and meta-analysis) and issues unique to surgical trials
2:00–3:00 pm	Lecture #2: Peter R. Nelson, MD, FACS—The Question and End Points
3:00–5:00 pm	Breakout: Begin the process of topic/alternate topic selection

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Day 2—Saturday, November 14, 2009

7:00–8:00 am	Breakfast
8:00–9:00 am	Lecture #3: Lawrence T. Kim, MD, FACS—Patient Selection: Selecting, recruiting, and retaining subjects; sampling strategies and external validity inclusion/exclusion criteria; stratification; impact of managed care; and problems with accrual
9:00–10:00 am	Lecture #4: Robert J. Anderson, PhD—Experimental Design for a Randomized Clinical Trial: Techniques of randomization and stratification
10:00–10:30 am	Coffee Break
10:30–11:30 am	Lecture #5: Dorothy D. Dunlop, PhD—Statistical Inference, Hypothesis Testing, and Sample Size
11:30 am–12:30 pm	Lecture #6: David M. Ota, MD, FACS—Interventions
12:30–1:30 pm	Lunch
1:30–5:30 pm	Breakout: Complete topic selection and conduct literature search
6:30–8:00 pm	Group Dinner

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Day 3—Sunday, November 15, 2009

7:00–8:00 am	Breakfast
8:00–9:00 am	Lecture #7: Joseph F. Collins, ScD—Statistical Concepts in Clinical Trials: Rationale for randomized trials, statistical testing, factorial designs, intent-to-treat analysis, large simple trials, and meta-analyses
9:00–10:00 am	Lecture #8: Layton F. Rikkers, MD, FACS—Publication of Results
10:00–10:30 am	Coffee Break
10:30–11:30 am	Lecture #9: Kamal M. F. Itani, MD, FACS—Ethics of Clinical Trials
11:30 am–12:30 pm	Lecture #10: Domenic Reda, PhD—Clinical Trials Analysis Methods: Statistical methods, tests of significance, intention to treat, multiple end points, repeated measurements, subgroup analysis, and crossover problems
12:30–1:30 pm	Lunch
1:30–5:30 pm	Breakout: Work with sample-size software and begin to outline proposal.

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Day 4—Monday, November 16, 2009

7:00–8:00 am	Breakfast
8:00–9:00 am	Lecture #11: Eric L. Lazar, MD, FACS—Putting it all Together: How to Get a Clinical Trial Paid For
9:00–10:00 am	Lecture #12: William R. Clark, PhD—Trial Management and Planning Measurements
10:00–11:00 am	Lecture #13: William G. Henderson, PhD—Mistakes in Clinical Trials
11:00 am–5:30 pm	Breakout: Complete and distribute proposal.
12:30–1:30 pm	Lunch

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Day 5—Tuesday, November 17, 2009

6:00–7:00 am	Breakfast
7:00 am–12:00 pm	Presentations: Presentation of proposals from individual groups. Discussion and scoring after each presentation.
12:00–1:00 pm	Wrap-up and Conclusions

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Overview | 2009 Course Schedule | 2009 Course Faculty
2007 Course Bibliography | Online Registration