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Abstract Details

Activity Number: 35
Type: Contributed
Date/Time: Sunday, July 29, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304161
Title: The Actual Practice of Randomization: Is Your Study as Balanced as You Planned?
Author(s): Michael Collins*+ and Eva Ruth Miller
Companies: ICON Clinical Research and ICON Clinical Research
Address: 212 Church Road, North Wales, PA, 19451, United States
Keywords: randomization ; intent-to-treat ; per protocol ; safety ; analysis ; IVRS

The scientific integrity of a clinical trial greatly depends on the credibility of the randomization records. Typical misrandomization scenarios that compromise data integrity are (1) Screen fail subjects continuing to randomization, (2)Multiple randomizations of the same subject, (3)Misclassification of subject stratifying information, and (4)Incorrect treatments administered to subjects. These errors may be detrimental to the overall study balance, patient population, or intent to treat principal but applying valid statistical methods in order to correct these errors will save data integrity. The discussed practices will allow the opportunity to gather the protocol statistician's input on a case by case basis in a suitable timeframe in order to authorize data modifications. Providing these updates to the randomization schedules while maintaining the study blind facilitates the data cle

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