Jun 9, 2022 19:09
2 yrs ago
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English term
Russian Federation
10+ years of experience in Pharma
Native in: Russian (Variant: Standard-Russia)
Works in: English to Russian, Russian to English
stopping for efficacy at the IA
English to Russian
Medical
Medical: Pharmaceuticals
All hypothesis testing will be performed using 2-sided tests at the 0.05 level of significance. However, in the event of any IA (see Section 11), where there is an alpha-spending due to stopping rules for efficacy, the left-over alpha will be applied as the level of significance at the end of the study. In case of stopping for efficacy at the IA, the key secondary endpoints will be tested at the adjusted alpha level which will be specified in the SAP.Hypothesis testing will be conducted in prespecified hierarchical order to control for overall type I error.
Proposed translations
29 mins
Selected
прекращение лечения в связи с недостаточной эффективностью по результатам промежуточного анализа
IA = interim analysis = промежуточный анализ
4 KudoZ points awarded for this answer.
32 mins
прекращение исследования в связи с вопросами эффективности по результатам промежуточного анализа
Исследование может досрочно прекратиться не только из-за недостаточной эффективности, но и по причине полученных доказательств высокой эффективности.
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"For case of early termination for superiority
...the simulation results in the case of early termination for superiority at the one interim analysis which is done with 60 patients. In this table, we report power or size (overall type I error rate), the expected sample size during the study (E[M]), the probability to conduct an interim analysis (IA), the probability to terminate the trial at the interim analysis for superiority of the new therapy (Sig.IA)
... ... ... ... ...
For case of early termination for futility
...consider early stopping for futility, instead of superiority. Specifically, at the planned interim analysis time point, we calculate the conditional probability. If it is below 0.2, we stop the trial.
... ... ... ... ...
For case of early termination for superiority and futility
We now consider the case with both superiority and futility stopping rules. Specifically, at the interim analysis, we will stop the trial for superiority if the observed p-value is less than 0.01, or for futility if the conditional probability is less than 0.2. ".
https://www.sciencedirect.com/science/article/pii/S245186541...
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Note added at 2 days 12 hrs (2022-06-12 08:00:19 GMT)
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"The Haybittle–Peto boundary is one such stopping rule, and it states that if an interim analysis shows a probability of equal to, or less than 0.001 that a difference as extreme or more between the treatments is found, given that the null hypothesis is true, then the trial should be stopped early. The final analysis is still evaluated at the normal level of significance (usually 0.05).[3][4]
The main advantage of the Haybittle–Peto boundary is that the same threshold is used at every interim analysis, unlike the O'Brien–Fleming boundary, which changes at every analysis. Also, using the Haybittle–Peto boundary means that the final analysis is performed using a 0.05 level of significance as normal, which makes it easier for investigators and readers to understand".
https://en.wikipedia.org/wiki/Haybittle–Peto_boundary
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"For case of early termination for superiority
...the simulation results in the case of early termination for superiority at the one interim analysis which is done with 60 patients. In this table, we report power or size (overall type I error rate), the expected sample size during the study (E[M]), the probability to conduct an interim analysis (IA), the probability to terminate the trial at the interim analysis for superiority of the new therapy (Sig.IA)
... ... ... ... ...
For case of early termination for futility
...consider early stopping for futility, instead of superiority. Specifically, at the planned interim analysis time point, we calculate the conditional probability. If it is below 0.2, we stop the trial.
... ... ... ... ...
For case of early termination for superiority and futility
We now consider the case with both superiority and futility stopping rules. Specifically, at the interim analysis, we will stop the trial for superiority if the observed p-value is less than 0.01, or for futility if the conditional probability is less than 0.2. ".
https://www.sciencedirect.com/science/article/pii/S245186541...
--------------------------------------------------
Note added at 2 days 12 hrs (2022-06-12 08:00:19 GMT)
--------------------------------------------------
"The Haybittle–Peto boundary is one such stopping rule, and it states that if an interim analysis shows a probability of equal to, or less than 0.001 that a difference as extreme or more between the treatments is found, given that the null hypothesis is true, then the trial should be stopped early. The final analysis is still evaluated at the normal level of significance (usually 0.05).[3][4]
The main advantage of the Haybittle–Peto boundary is that the same threshold is used at every interim analysis, unlike the O'Brien–Fleming boundary, which changes at every analysis. Also, using the Haybittle–Peto boundary means that the final analysis is performed using a 0.05 level of significance as normal, which makes it easier for investigators and readers to understand".
https://en.wikipedia.org/wiki/Haybittle–Peto_boundary
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