TL46: Issues in Clinical Trials with a Time Lag between Randomization and Initiation of Treatment
*Chunrong Cheng, FDA/CBER Keywords: In some clinical trials, there is a time lag between randomization and the initiation of treatment due to the individualized production of investigated product. When the time lag is long enough, a substantial proportion of subjects may drop out during this period and result in missing data. Due to production failure, subjects randomized to the treatment group may also be forced to drop out. Bias will be introduced if excluding these subjects from the analyses. This session will discuss statistical strategies to deal with this issue and the feasibility of alternative timing for randomization.
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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