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Activity Number: 177
Type: Contributed
Date/Time: Monday, August 5, 2013 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #310082
Title: Tumor Dynamics and Central-Review Bias in Progression-Free Survival Clinical Trials
Author(s): Jonathan Siegel*+
Companies: Bayer HealthCare Pharmaceuticals
Keywords: PFS ; progression-free survival ; bias ; informative censoring ; central review ; cancer
Abstract:

Progression-free survival (PFS), a common cancer clinical trial endpoint, has issues with bias. Past oncology literature has posited bias in investigator judgment (Dodd et al, 2008), and the FDA has accordingly required blinded central review of tumor assessments. Meta-analyses of tumor assessment studies, however, have not found systematic bias in investigator decision-making (Amit et al, 2011). The FDA has recently re-examined its central review requirement. Bias may result from informative censoring introduced by interactions of trial and review procedures. Fleisher et al. (2011) showed that retrospective review, even when individually unbiased, introduces informative censoring bias when the investigator false-positive PD rate varies at different timepoints prior to central review. This presentation examines the effects of disease growth and treatment dynamics on error rates and hence on the degree of informative censoring bias central review induces, using models of tumor growth and treatment pharmacodynamics. The appropriateness of central review may not be monolithic for all cancers and assessment methods, but may depend on disease type and assessment technology.


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