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

Sooriyarachchi, M.R., Whitehead, J., Matsushita, T., Bolland, K. and Whitehead, A. (2003) Incorporating data received after a sequential trial has stopped into the final analysis: implementation and comparison of methods. Biometrics, 59 (3). pp. 701-709. ISSN 0006-341X

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To link to this article DOI: 10.1111/1541-0420.00081

Abstract/Summary

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.

Item Type:Article
Refereed:Yes
Divisions:Faculty of Science > School of Mathematical and Physical Sciences > Department of Mathematics and Statistics > Applied Statistics
ID Code:9457
Uncontrolled Keywords:Clinical trials, Delayed data, Interim analysis, Overrunning, P-value function, Sequential methods

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