Properties of Historical Borrowing in Clinical Trials
View Presentation *Kert Viele , Berry Consultants, LLC Keywords: Historical data, Conflicts, Clinical trial design Clinical trials rarely occur in vacuum. Generally historical information, perhaps extensive, is available on the comparator arms in a study. When applicable, this information presents the opportunity to design more efficient trials, achieving superior power, type I error, and mean square error of estimation properties that trials which do not utilize this information. However, the potential for drift in the comparator effect also gives the potential for bias, reduced power, or inflated type I error. In this talk we review some common methods for borrowing historical information within a trial and illustrate when and how the information provides benefit to a trial as opposed to reducing efficiently. Unfortunately, knowing whether or not historical information will help a trial depends on unknown parameters (the discrepancy between the historical and current studies). We then focus on what kinds of long term distributions of that discrepancy would result in a drug development process that is on average more efficient than ignoring the historical information.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC