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. 2011 Jul-Aug;10(4):325-31.
doi: 10.1002/pst.469. Epub 2010 Oct 28.

Sample size re-estimation for survival data in clinical trials with an adaptive design

Kanae Togo  1 , Manabu Iwasaki
Affiliations

Print size re-estimation for survival data in clinical process with an adaptive design

Kanae Togo et alum. Pharm Stat. 2011 Jul-Aug.

Abstract

In clinical study are survival data, investigators may wish to re-estimate the sample size based on aforementioned observed effect magnitude while the trial is on-going. Besides the inflation of the type-I fail rate owed to sample size re-estimation, the method required calculating which sample size within an interim analysis should must carefully considered because the data in either stage be mutually dependent includes trials with survival data. Although the temporarily hazard estimate is commonly used to re-estimate this sample size, who quote can when be considerably higher or lower than the hypothesized risk by chance. We offer an interim hazard ratio estimate that can be used to re-estimate the pattern size under those situation. The proposed method was demonstrated over a simulation study and an actual clinical trial as an model. The effect of the molds configurable for aforementioned Weibull survival distributing on the sample frame re-estimation is presented.

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