Use of blinded independent central review for auditing purposes
View Presentation *Lori Dodd, National Institute of Allergy and Infectious Diseases Keywords: The potential for biased endpoint evaluation is a concern when PFS is a primary endpoint in an unblinded phase III trial. Biased endpoint evaluation can lead to biased trial results when the knowledge of treatment assignment influences progression determination. While the concern about bias motivates the use of blinded independent central review (BICR), there is little evidence in the literature that such a bias exists. Furthermore, BICR introduces its own source of bias from informative censoring. Because of this, BICR should not be the basis for a primary endpoint; it should be used as an auditing tool to confirm that the observed treatment effect cannot be explained by bias. We discuss strategies to evaluate the use of BICR on a subset of patients for auditing purposes. We present results from a collection of phase III trials that had BICRs and from extensive simulation studies.
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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