Results 151 to 160 of about 25,475 (182)
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Monitoring the Rates of Composite Events with Censored Data in Phase II Clinical Trials
Biometrics, 2002Summary. In many phase II clinical trials, interim monitoring is based on the probability of a binary event, response, defined in terms of one or more time‐to‐event variables within a time period of fixed length. Such outcome‐adaptive methods may require repeated interim suspension of accrual in order to follow each patient for the time period ...
Cheung, Ying Kuen, Thall, Peter F.
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RMST for Interval‐Censored Data in Oncology Clinical Trials
Statistics in MedicineABSTRACTIn oncology studies, the assumption of proportional hazards is often questionable due to factors such as the presence of cured patients, a delayed treatment benefit, and possible treatment switching. The restricted mean survival time (RMST) has emerged as a valuable alternative summary measure to the hazard ratio (HR) in this scenario as it ...
Xiyuan Gao +8 more
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Statistics in Medicine, 1992
AbstractClinical trials often involve a variety of clinical and laboratory measures that are used as endpoints and sometimes two of these measures are combined in one endpoint. When the individual components of such a combined endpoint are ‘time to event’ measurements, the analysis is straightforward if each of the components is measured frequently and
L A, Moyé, B R, Davis, C M, Hawkins
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AbstractClinical trials often involve a variety of clinical and laboratory measures that are used as endpoints and sometimes two of these measures are combined in one endpoint. When the individual components of such a combined endpoint are ‘time to event’ measurements, the analysis is straightforward if each of the components is measured frequently and
L A, Moyé, B R, Davis, C M, Hawkins
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Missing Data and Censoring in the Analysis of Progression-Free Survival in Oncology Clinical Trials
Journal of Biopharmaceutical Statistics, 2013Progression-free survival (PFS) is increasingly used as a primary endpoint in oncology clinical trials. However, trial conduct is often such that PFS data on some patients may be partially missing either due to incomplete follow-up for progression, or due to data that may be collected but confounded by patients stopping randomized therapy or starting ...
J S, Denne +3 more
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Biometrics, 2018
SummaryLan and DeMets (1983) proposed the alpha spending function for group sequential trials to permit the use of unspecified frequencies and timings of interim analyses in the trial design. Regarding a trial with censored time to endpoint, Lan and DeMets (1989) later defined information time at an interim analysis in a maximum duration trial.
Chih-Yuan Hsu +3 more
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SummaryLan and DeMets (1983) proposed the alpha spending function for group sequential trials to permit the use of unspecified frequencies and timings of interim analyses in the trial design. Regarding a trial with censored time to endpoint, Lan and DeMets (1989) later defined information time at an interim analysis in a maximum duration trial.
Chih-Yuan Hsu +3 more
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Statistics in Medicine, 1992
AbstractThe study duration in a clinical trial with censored survival data is the sum of the accrual duration, which determines the sample size in a traditional sense, and the follow‐up duration, which more or less controls the number of events to be observed. We propose a design procedure for determining the study duration or for calculating the power
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AbstractThe study duration in a clinical trial with censored survival data is the sum of the accrual duration, which determines the sample size in a traditional sense, and the follow‐up duration, which more or less controls the number of events to be observed. We propose a design procedure for determining the study duration or for calculating the power
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JNCI: Journal of the National Cancer Institute
Abstract Differential censoring, which refers to censoring imbalance between treatment arms, may bias the interpretation of survival outcomes in clinical trials. In 146 phase III oncology trials with statistically significant time-to-event surrogate primary endpoints, we evaluated the association between differential censoring in the ...
Eric J Hsu +23 more
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Abstract Differential censoring, which refers to censoring imbalance between treatment arms, may bias the interpretation of survival outcomes in clinical trials. In 146 phase III oncology trials with statistically significant time-to-event surrogate primary endpoints, we evaluated the association between differential censoring in the ...
Eric J Hsu +23 more
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Journal of Statistical Planning and Inference, 1997
zbMATH Open Web Interface contents unavailable due to conflicting licenses.
Coad, D. S., Woodroofe, M. B.
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zbMATH Open Web Interface contents unavailable due to conflicting licenses.
Coad, D. S., Woodroofe, M. B.
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JAIDS Journal of Acquired Immune Deficiency Syndromes, 2004
The magnitude of reduction in HIV-1 RNA levels provides an important complement to the end point based on the percentage of patients achieving HIV-1 RNA levels below a threshold value. Analyses and interpretation of this end point, however, is difficult due to the lower limit of quantification.
Philippe, Flandre +4 more
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The magnitude of reduction in HIV-1 RNA levels provides an important complement to the end point based on the percentage of patients achieving HIV-1 RNA levels below a threshold value. Analyses and interpretation of this end point, however, is difficult due to the lower limit of quantification.
Philippe, Flandre +4 more
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