Analyzing Progression Free Survival: A Meta-analysis of 28 Trials to Explore the Impact of Censoring Rules.
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*Jonathan Denne, Eli Lilly  Renee Iacona, Eli Lilly  Andrew Stone, Eli Lilly 


A PhRMA working group on Progression Free Survival was established in 2008 to consider issues related to the use of this endpoint for drug approval, and improve study design and analysis. One important topic addressed was that concerning how to handle missing data, and other issues in follow-up, such as patients who start other anti-cancer therapy prior to progression, or who miss scans. Regulatory guidance differs in how to handle these situations. In order to explore the impact of different rules for handling these situations, a meta-analysis was conducted using the results of defined analyses on 28 trials submitted by the participating representatives. The results of this meta-analysis, comparing several censoring rules with an ITT approach, will be presented.