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Incorporating intermediate binary responses into interim analyses of clinical trials : a comparison of four methods.

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Incorporating intermediate binary responses into interim analyses of clinical trials : a comparison of four methods. / Whitehead, Anne; Sooriyarachchi, Marina Roshini; Whitehead, John et al.
In: Statistics in Medicine, Vol. 27, No. 10, 10.05.2008, p. 1646-1666.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

Harvard

Whitehead, A, Sooriyarachchi, MR, Whitehead, J & Bolland, K 2008, 'Incorporating intermediate binary responses into interim analyses of clinical trials : a comparison of four methods.', Statistics in Medicine, vol. 27, no. 10, pp. 1646-1666. https://doi.org/10.1002/sim.3046

APA

Whitehead, A., Sooriyarachchi, M. R., Whitehead, J., & Bolland, K. (2008). Incorporating intermediate binary responses into interim analyses of clinical trials : a comparison of four methods. Statistics in Medicine, 27(10), 1646-1666. https://doi.org/10.1002/sim.3046

Vancouver

Whitehead A, Sooriyarachchi MR, Whitehead J, Bolland K. Incorporating intermediate binary responses into interim analyses of clinical trials : a comparison of four methods. Statistics in Medicine. 2008 May 10;27(10):1646-1666. doi: 10.1002/sim.3046

Author

Whitehead, Anne ; Sooriyarachchi, Marina Roshini ; Whitehead, John et al. / Incorporating intermediate binary responses into interim analyses of clinical trials : a comparison of four methods. In: Statistics in Medicine. 2008 ; Vol. 27, No. 10. pp. 1646-1666.

Bibtex

@article{f940c319cd1f44a1b11a19473d8f66a7,
title = "Incorporating intermediate binary responses into interim analyses of clinical trials : a comparison of four methods.",
abstract = "In clinical trials with a long period of time between randomization and the primary assessment of the patient, the same assessments are often undertaken at intermediate times. When an interim analysis is conducted, in addition to the patients who have completed the primary assessment, there will be those who have till then undergone only intermediate assessments. The efficiency of the interim analysis can be increased by the inclusion of data from these additional patients. This paper compares four methods of increasing information based on model-free estimates of transition probabilities to incorporate intermediate assessments from patients who have not completed the trial. It is assumed that the observations are binary and that there is one intermediate assessment. The methods are the score and Wald approaches, each with the log-odds ratio and probability difference parameterizations. Simulations show that all four approaches have good properties in moderate to large sample sizes.",
keywords = "binary data • longitudinal data • score test • sequential clinical trial • Wald test",
author = "Anne Whitehead and Sooriyarachchi, {Marina Roshini} and John Whitehead and Kim Bolland",
year = "2008",
month = may,
day = "10",
doi = "10.1002/sim.3046",
language = "English",
volume = "27",
pages = "1646--1666",
journal = "Statistics in Medicine",
issn = "1097-0258",
publisher = "John Wiley and Sons Ltd",
number = "10",

}

RIS

TY - JOUR

T1 - Incorporating intermediate binary responses into interim analyses of clinical trials : a comparison of four methods.

AU - Whitehead, Anne

AU - Sooriyarachchi, Marina Roshini

AU - Whitehead, John

AU - Bolland, Kim

PY - 2008/5/10

Y1 - 2008/5/10

N2 - In clinical trials with a long period of time between randomization and the primary assessment of the patient, the same assessments are often undertaken at intermediate times. When an interim analysis is conducted, in addition to the patients who have completed the primary assessment, there will be those who have till then undergone only intermediate assessments. The efficiency of the interim analysis can be increased by the inclusion of data from these additional patients. This paper compares four methods of increasing information based on model-free estimates of transition probabilities to incorporate intermediate assessments from patients who have not completed the trial. It is assumed that the observations are binary and that there is one intermediate assessment. The methods are the score and Wald approaches, each with the log-odds ratio and probability difference parameterizations. Simulations show that all four approaches have good properties in moderate to large sample sizes.

AB - In clinical trials with a long period of time between randomization and the primary assessment of the patient, the same assessments are often undertaken at intermediate times. When an interim analysis is conducted, in addition to the patients who have completed the primary assessment, there will be those who have till then undergone only intermediate assessments. The efficiency of the interim analysis can be increased by the inclusion of data from these additional patients. This paper compares four methods of increasing information based on model-free estimates of transition probabilities to incorporate intermediate assessments from patients who have not completed the trial. It is assumed that the observations are binary and that there is one intermediate assessment. The methods are the score and Wald approaches, each with the log-odds ratio and probability difference parameterizations. Simulations show that all four approaches have good properties in moderate to large sample sizes.

KW - binary data • longitudinal data • score test • sequential clinical trial • Wald test

U2 - 10.1002/sim.3046

DO - 10.1002/sim.3046

M3 - Journal article

VL - 27

SP - 1646

EP - 1666

JO - Statistics in Medicine

JF - Statistics in Medicine

SN - 1097-0258

IS - 10

ER -