stopping for efficacy at the IA
Russian translation: прекращение лечения в связи с недостаточной эффективностью по результатам промежуточного анализа
| 19:09 Jun 9, 2022 |
| English to Russian translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
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|  Selected response from: Natalie Poland Local time: 01:22 | ||||||
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Answers
29 mins confidence: 
| stopping for efficacy at the ia прекращение лечения в связи с недостаточной эффективностью по результатам промежуточного анализа Explanation: IA = interim analysis = промежуточный анализ |
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32 mins confidence:
| stopping for efficacy at the ia прекращение исследования в связи с вопросами эффективности по результатам промежуточного анализа Explanation: Исследование может досрочно прекратиться не только из-за недостаточной эффективности, но и по причине полученных доказательств высокой эффективности. --- "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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