Institute of Mathematical Statistics Collections

Sequential tests and estimates after overrunning based on p-value combination

W. J. Hall, Keyue Ding

Abstract

Often in sequential trials additional data become available after a stopping boundary has been reached. A method of incorporating such information from overrunning is developed, based on the “adding weighted Zs” method of combining p-values. This yields a combined p-value for the primary test and a median-unbiased estimate and confidence bounds for the parameter under test. When the amount of overrunning information is proportional to the amount available upon terminating the sequential test, exact inference methods are provided; otherwise, approximate methods are given and evaluated. The context is that of observing a Brownian motion with drift, with either linear stopping boundaries in continuous time or discrete-time group-sequential boundaries. The method is compared with other available methods and is exemplified with data from two sequential clinical trials.

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Primary Subjects: 62L10
Secondary Subjects: 62P10
Keywords: delayed observations; deletion method; double sampling; lagged data; meta analysis; ML ordering; sequential clinical trial
Full-text: Open access
Links and Identifiers

Permanent link to this document: http://projecteuclid.org/euclid.imsc/1209398458
Digital Object Identifier: doi:10.1214/074921708000000039

References

[1] Anderson, T. W. (1964). Sequential analysis with delayed observations. J. Amer. Statist. Assoc. 59 1006–1015.
Mathematical Reviews (MathSciNet): MR175262
Zentralblatt MATH: 0211.49703
Digital Object Identifier: doi:10.2307/2282620
[2] Brannath, W., Posch, M. and Bauer, P. (2002). Recursive combination tests. J. Amer. Statist. Assoc. 97 236–244.
Mathematical Reviews (MathSciNet): MR1947283
Zentralblatt MATH: 1073.62550
Digital Object Identifier: doi:10.1198/016214502753479374
[3] Hall, W. J. (1997). The distribution of Brownian motion on linear stopping boundaries. Sequential Analysis 16 345–352. Addendum in Sequential Analysis 17 123–124.
Mathematical Reviews (MathSciNet): MR1491641
[4] Hall, W. J. and Liu, A. (2002). Sequential tests and estimators after overrunning based on maximum-likelihood ordering. Biometrika 89 699–707.
Mathematical Reviews (MathSciNet): MR1929173
Zentralblatt MATH: 1037.62079
Digital Object Identifier: doi:10.1093/biomet/89.3.699
[5] Jennison, C. (1999). Group sequential software at website: http://www.bath.ac.uk/ mascj/book/programs/general.
[6] Jennison, C. and Turnbull, B. W. (2000). Group Sequential Methods with Applications to Clinical Trials. Chapman & Hall/CRC, Boca Raton, FL.
Mathematical Reviews (MathSciNet): MR1710781
Zentralblatt MATH: 0934.62078
[7] Liptak, T. (1958). On the combination of independent tests. Magyar Tud. Akad. Mat. Kutato Int. Közl. 3 171–197.
[8] Moss, A. J., Hall, W. J., Cannom, D. S., Daubert, J. P., Higgins, M. D., Klein, H., Levine, J. H., Saksena, S., Waldo, A. L., Wilber, D., Brown, M. W., Heo, M.; for the Multicenter Automatic Defibrillator Implantation Trial Investigators (1996). Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. New England Journal of Medicine 335 1933–1940.
[9] Moss, A. J., Zareba, W., Hall, W. J., Klein, H., Wilber, D. J., Cannom, D. S., Daubert, J. P., Higgins, S. L., Brown, M. W., Andrews, M. L.; for the Multicenter Automatic Defibrillator Implantation Trial-II Investigators (2002). Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. New England J. Medicine 346 877–883.
[10] Mosteller, F. M. and Bush, R. R. (1954). Selected quantitative techniques. In Handbook of Social Psychology I. Theory and Methods (G. Lindzey, ed.). Addison-Wesley, Cambridge, MA.
[11] MPS Research Unit (2000). PEST: Planning and Evaluation of Sequential Trials, Version 4: Operating Manual. University of Reading, Reading, UK.
[12] Oosterhoff, J. (1969). Combination of One-Sided Statistical Tests. The Mathematical Centre, Amsterdam.
Mathematical Reviews (MathSciNet): MR247707
Zentralblatt MATH: 0193.15901
[13] Rosenthal, R. (1978). Combining results of independent studies. Psych. Bull. 85 185–193.
[14] 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 59 701–709.
Mathematical Reviews (MathSciNet): MR2004276
Digital Object Identifier: doi:10.1111/1541-0420.00081
[15] Stouffer, S. A., Suchman, E. A., DeVinner, L. C., Star, R. M., Williams, R. M. (1949). The American Soldier: Adjustment During Army Life I. Princeton Univ. Press, Princeton, NJ.
[16] Whitehead, J. (1992). Overrunning and underrunning in sequential clinical trials. Controlled Clinical Trials 13 106–121.
[17] Whitehead, J. (1997). The Design and Analysis of Sequential Clinical Trials, 2nd ed. revised. Wiley, New York.
Mathematical Reviews (MathSciNet): MR793018

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Institute of Mathematical Statistics Collections

Institute of Mathematical Statistics Collections