A Statistical Reviewer’s Perspective on Sample Size Re-estimation
View Presentation *Boguang Zhen, FDA/CBER Keywords: sample size re-estimation, simulation There are many types of adaptive design and one of them is sample size re-estimation. It may provide the flexibility in clinical trial studies and may have the potential in increasing the chance of obtaining positive results from a trial (power). The application of sample size re-estimation in confirmative trial design is reviewed and issues are raised and discussed from a statistical reviewer’s stand point. A hypothetical example is presented for discussion for issues in this field, especially the one on sample size re-estimation approach using simulation study.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC