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

Marina Roshini Sooriyarachchi·John Whitehead·Tatsuru Matsushita·Kim Bolland·Anne Whitehead
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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.

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Marina Roshini Sooriyarachchi, John Whitehead, Tatsuru Matsushita, Kim Bolland, Anne Whitehead. 2003. Incorporating data received after a sequential trial has stopped into the final analysis: implementation and comparison of methods.. https://doi.org/10.1111/1541-0420.00081

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