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Incorporating Data Received after a Sequential Trial Has Stopped into the Final Analysis: Implementation and Comparison of Methods

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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.

Keywords: Clinical trials; Delayed data; Interim analysis; Overrunning; P-value function; Sequential methods

Document Type: Research Article


Affiliations: 1: Department of Statistics, University of Colombo, Sri Lanka 2: Medical and Pharmaceutical Statistics Research Unit, University of Reading, U.K.

Publication date: September 1, 2003

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