Registration Rate:
Regular Registration Fee: $645
ACS/Gov Registration Fee: $545
Cancellation Fee: $
Registration Policy
Register Now Online
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Continuing Education Credit:
ACPE: 708-000-08-990-H04-P/T - 1.2 CEU
Initial Release Date: 10/24/08
CME: 12 Hours of Category 1 Credit
VNA: 07-04-01 12 Contact Hours
Continuing Education Policy
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Course Description:
This course will review statistical terminology, provide an understanding of statistics, and explain trial design from a clinician's viewpoint. Most importantly, the course will illustrate how statistical tests are chosen and interpreted. The course is designed to allow you to think like a statistician, but it is not designed to teach you to be a statistician. The course will emphasize the importance of an ongoing collaboration with a statistician. It is this collaboration that creates synergy, enhances creativity, and improves trial design, execution, and analysis. You should expect to spend approximately 12 hours of study time to complete the course. You will have a four-month access after you register for the course.
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Who Should Attend:
This course is designed to teach statistical concepts used in clinical trials to physicians, clinical research administrators, and other individuals in the clinical environment of the pharmaceutical industry. Knowledge of statistics is not a prerequisite. However, the course assumes previous rudimentary exposure to statistics through work or the classroom.
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Educational Objectives:
- Identify the factors to consider in selecting clinical trial designs
- State the factors a statistician must keep in mind when choosing patient populations, trial endpoints, and the treatment difference to be detected
- List the information needed to calculate the clinical trial sample size
- Define the false positive rate alpha and power
- Discuss the required information the statistician needs in order to select the statistical test
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Key Topics:
- Statistics Before the Trial
- Clinical Trial Questions
- Clinical Trial Designs
- Statistical Background
- Sample and Population
- Statistical Inference
- Significance Testing
- Estimation
- Calculating the Sample Size of the Trial
- Statistics at the End of the Trial
- Choosing the Statistical Test
- Data Analysis
- Four Habits of Unsuccessful Statisticians
- Correcting for Multiplicity When There is No Multiplicity
- Averaging Categorical Endpoints
- Making Too Many Statistical Assumptions
- Misinterpreting Statistically Non-Significant Results
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Course Director(s):
Gregory D. Sides, MD
Medical Director
Bio Research Technologies & Proteins
Eli Lilly and Company
Alex Dmitrienko, PhD
Senior Statistician
Eli Lilly and Company
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Contact Course Manager:
Course Manager
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