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group sequential boundary

Russian translation: групповые последовательные границы

09:51 May 27, 2017
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: group sequential boundary
If the results of the interim analysis indicated serious safety concerns, the sponsor was to consult with Health Authorities regarding stopping the clinical study.

At each interim analysis, statistical hypothesis tests were performed only for the primary efficacy parameter, DFS (based on BICR).

The log-rank statistic stratified by UISS High-Risk group was calculated and compared to group sequential boundary.

The interim safety report would review all aspects of the data collected for each patients.

Other important additional factors that reflect the integrity of the protocol would be addressed in the interim reports.

As per the sponsor’s policy with respect to interim analyses of ongoing studies, distribution of the analyses was limited to appropriate individuals (eg, independent statistician, DMC members, and upper management to communicate results as necessary) and were not be shared with the study team or investigators nor broken down by center.
Maxim Polukhin
Local time: 19:54
Russian translation:групповые последовательные границы
Explanation:
http://webirbis.spsl.nsc.ru/irbis64r_01/cgi/cgiirbis_64.exe?...
Liu, Aiyi.
Sample size calculation for planning group sequential longitudinal trials [Text] : научное издание / Aiyi Liu, James M. Boyett, Xiaoping Xiong // Statist. Med. - 2000. - Vol. 19, N 2. - P205-220 . - ISSN 0277-6715
Перевод заглавия: Вычисление объема выборки для планирования групповых, последовательных продольных испытаний
Аннотация: Разработаны процедуры для вычисления объема выборки для планирования группового, последовательного продольного испытания с различными корреляционными структурами, используя статистические тесты на основе обобщенных оценочных уравнений (Lee, Kim и Tsiatis) и групповые последовательные границы на основе ошибки I типа используемых функций (Lan и DeMets). США, Georgetown Univ. Medical Center, Washington. Ил. 1. Табл. 1. Библ. 15

https://www.ncbi.nlm.nih.gov/pubmed/10641025
Stat Med. 2000 Jan 30;19(2):205-20.
Sample size calculation for planning group sequential longitudinal trials.
Liu A1, Boyett JM, Xiong X.
Abstract
Procedures are developed in this paper for sample size calculations for planning a group sequential longitudinal trial with various correlation structures, using a test statistic based on generalized estimating equations (Lee, Kim and Tsiatis) and group sequential boundaries based on type I error spending functions (Lan and DeMets)
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Marlin31
Russian Federation
Local time: 19:54
Grading comment
Спасибо!
4 KudoZ points were awarded for this answer



Summary of answers provided
4групповые последовательные границы
Marlin31


  

Answers


1 day 12 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
групповые последовательные границы


Explanation:
http://webirbis.spsl.nsc.ru/irbis64r_01/cgi/cgiirbis_64.exe?...
Liu, Aiyi.
Sample size calculation for planning group sequential longitudinal trials [Text] : научное издание / Aiyi Liu, James M. Boyett, Xiaoping Xiong // Statist. Med. - 2000. - Vol. 19, N 2. - P205-220 . - ISSN 0277-6715
Перевод заглавия: Вычисление объема выборки для планирования групповых, последовательных продольных испытаний
Аннотация: Разработаны процедуры для вычисления объема выборки для планирования группового, последовательного продольного испытания с различными корреляционными структурами, используя статистические тесты на основе обобщенных оценочных уравнений (Lee, Kim и Tsiatis) и групповые последовательные границы на основе ошибки I типа используемых функций (Lan и DeMets). США, Georgetown Univ. Medical Center, Washington. Ил. 1. Табл. 1. Библ. 15

https://www.ncbi.nlm.nih.gov/pubmed/10641025
Stat Med. 2000 Jan 30;19(2):205-20.
Sample size calculation for planning group sequential longitudinal trials.
Liu A1, Boyett JM, Xiong X.
Abstract
Procedures are developed in this paper for sample size calculations for planning a group sequential longitudinal trial with various correlation structures, using a test statistic based on generalized estimating equations (Lee, Kim and Tsiatis) and group sequential boundaries based on type I error spending functions (Lan and DeMets)

Marlin31
Russian Federation
Local time: 19:54
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 436
Grading comment
Спасибо!
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