2007 Course in Clinical Trials Methods

ACS Headquarters and the Wyndham Hotel
Chicago, IL
November 9-13, 2007

Preliminary Course Schedule

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

Day 1 - Friday, November 9, 2007

4:00 - 5:00 pm

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

5:00 - 6:00 pm

Lecture # 2: The Question and End Points

6:15 – 7:30 pm

Group Reception

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Day 2 - Saturday, November 10, 2007

7:00 - 8:00 am

Breakfast

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

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

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

7:00 - 8:00 am

Breakfast

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.

9:00 - 10:00 am Lecture #8: Publication of Results
10:00 - 10:30 am

Coffee Break

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
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

7:00 - 8:00 am

Breakfast

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

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 | 2007 Course Schedule | 2007 Course Faculty | 2007 Course Bibliography

 
Revised June 27, 2008


Surgical Research Committee

 


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