Bayesian Clinical Events Timeline Projection

• Activity Number: 595
• Type: Topic Contributed
• Date/Time: Thursday, August 7, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Korean International Statistical Society
• Author(s): Suresh Ankolekar*+ and Anthiyur Kannappan and Nitin Patel and Pralay Senchaudhuri
• Companies: Maastricht School of Management and Cytel and Cytel and Cytel
• Keywords: Clinical trial events timeline ; Poisson-Gamma model ; Bayesian updates ; events milestone prediction

Abstract

Reliable events timeline projection is critical to support decision-making in planning and execution of time-to-event clinical trials. This talk will discuss a simulation approach for events timeline projection using Poisson-Gamma model in two real-life multicentre oncology trials. The model works in conjunction with related enrollment timeline projection model. The model parameters include hazard rates for piecewise exponential distribution for clinical events and rates of dropout. The parameters are estimated on the basis of design assumptions specified in a typical clinical trial protocol. The parameters are used to estimate shape and scale parameters of related Gamma distributions corresponding to each segment of piecewise exponential distribution. During the trial, all available information on observed enrollments, and clinical events/dropouts is progressively used for Bayesian updates of the Gamma parameters. In addition to the events, timeline projection in terms of 95% credible intervals and other specified percentiles of interest, the model also generates probability distribution of reaching specific events milestones, including effective scheduling of DMC review meetings.