Milestone prediction for time-to-event endpoint monitoring in clinical trials

Pharmaceutical Statistics
Fang-Shu OuQian Shi

Abstract

Predicting the times of milestone events, ie, interim and final analyses in clinical trials, helps resource planning. This manuscript presents and compares several easily implemented methods for predicting when a milestone event is achieved. We show that it is beneficial to combine the predictions from different models to craft a better predictor through prediction synthesis. Furthermore, a Bayesian approach provides a better measure of the uncertainty involved in prediction of milestone events. We compare the methods through two simulations where the model has been correctly specified and where the models are a mixture of three incorrectly specified model classes. We then apply the methods on two real clinical trial data, North Central Cancer Treatment Group (NCCTG) N0147 and N9841. In summary, the Bayesian prediction synthesis methods automatically perform well even when the data collection is far from homogeneous. An R shiny app is under development to carry out the prediction in a user-friendly fashion.

References

Jul 6, 2001·Statistics in Medicine·E Bagiella, D F Heitjan
Nov 11, 2005·Clinical Trials : Journal of the Society for Clinical Trials·Gui-shuang YingTai-Tsang Chen
Jul 20, 2007·Statistics in Medicine·Vladimir V Anisimov, Valerii V Fedorov
Nov 6, 2007·Statistics in Medicine·Byron J GajewskiSusan E Carlson
Apr 22, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·George P KimHenry C Pitot
Dec 6, 2011·Pharmaceutical Statistics·Vladimir V Anisimov
Jul 19, 2015·Contemporary Clinical Trials·Daniel F HeitjanGui-Shuang Ying
Feb 3, 2016·BMC Medical Research Methodology·Tai-Tsang Chen
Jan 30, 2018·Clinical Trials : Journal of the Society for Clinical Trials·Yu Lan, Daniel F Heitjan

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Citations

Sep 21, 2021·Statistics in Medicine·Paul AubelGaëlle Saint-Hilary

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