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Incorporating data received after a sequential trial has stopped into the final analysis: implementation and comparison of methods.

Research output: Contribution to journalJournal article

Published

Journal publication date09/2003
JournalBiometrics
Journal number3
Volume59
Number of pages9
Pages701-709
Original languageEnglish

Abstract

In a sequential clinical trial, accrual of data on patients often continues after the stopping criterion for the study has been met. This is termed "overrunning." Overrunning occurs mainly when the primary response from each patient is measured after some extended observation period. The objective of this article is to compare two methods of allowing for overrunning. In particular, simulation studies are reported that assess the two procedures in terms of how well they maintain the intended type I error rate. The effect on power resulting from the incorporation of "overrunning data" using the two procedures is evaluated.

Bibliographic note

RAE_import_type : Journal article RAE_uoa_type : Statistics and Operational Research