Use of blinded independent central review for auditing purposes
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*Lori Dodd, National Institute of Allergy and Infectious Diseases 


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.