Occurrence of delay in patient responses is common in clinical trials in which a large difference exists between treatment administration and outcome observation. When this delay happens after that the trial was stopped in according to a priori fixed stopping criterion, it takes the name of overrunning. Overrunning basically consist of extra data, collected by investigators when waiting for the results of the ad-interim analyses. The inclusion of such extra data in the analyses is scientifically appropriate and follows regulatory advice. This article aims at clarifying the effect of including such overrunning data, providing first a revision and then a comparison of the several approaches proposed in literature for dealing with them. A simulation study is performed on the basis of two real-life examples.

Overrunning in Clinical Trials: a Methodological Review

SORIANI, NICOLA;BALDI, ILEANA;GREGORI, DARIO
2013

Abstract

Occurrence of delay in patient responses is common in clinical trials in which a large difference exists between treatment administration and outcome observation. When this delay happens after that the trial was stopped in according to a priori fixed stopping criterion, it takes the name of overrunning. Overrunning basically consist of extra data, collected by investigators when waiting for the results of the ad-interim analyses. The inclusion of such extra data in the analyses is scientifically appropriate and follows regulatory advice. This article aims at clarifying the effect of including such overrunning data, providing first a revision and then a comparison of the several approaches proposed in literature for dealing with them. A simulation study is performed on the basis of two real-life examples.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11577/2703294
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