sham-controlled studies

Russian translation: контролируемые исследования с имитационной процедурой введения

15:32 Sep 4, 2021

English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals

English term or phrase: sham-controlled studies

The primary support for the efficacy of nusinersen in the treatment of SMA derives from sham-controlled studies in participants with infantile-onset SMA (primarily Type I SMA) and later-onset SMA (may include Type II and Type III SMA). Results from uncontrolled studies in genetically diagnosed presymptomatic infants, participants with infantile-onset SMA, and participants with later-onset SMA are highly supportive of the results of the pivotal sham-controlled efficacy studies and provide evidence of long-term benefit. Nusinersen has been administered to 352 unique participants with SMA in 10 clinical studies to date, with safety data available for 346 participants during 665 person-years of exposure. Treatment with nusinersen has been well tolerated, and the SAE profile is consistent with the events seen in infants and children with SMA.

Anastasia Serdyukova KudoZ activity Questions: 4811 (none open) (20 closed without grading) Answers: 0 Russian Federation
Local time: 19:16

Russian translation:контролируемые исследования с имитационной процедурой введения

Explanation:
В таких исследованиях в роли "плацебо" выступает имитационное введение пустышки (чаще всего в форме инъекции), чтобы обеспечить маскировку. Иначе те, кому не делают укол, поймут, что им не дают активный препарат.

Selected response from:

Tatiana Nikitina
Russian Federation
Local time: 19:16

Grading comment

4 KudoZ points were awarded for this answer

Summary of answers provided

4 +1

контролируемые исследования с имитационной процедурой введения

Tatiana Nikitina

Summary of reference entries provided

José Patrício

Answers

17 mins confidence:

peer agreement (net): +1

контролируемые исследования с имитационной процедурой введения

Tatiana Nikitina
Russian Federation
Local time: 19:16
Specializes in field
Native speaker of: Russian
PRO pts in category: 400

Reference comments

2 hrs

Reference

Reference information:
A sham procedure can be defined as one performed on a control group participant to ensure that he or she experiences the same incidental effects of the operation or procedure as do those participants on whom a true operation is performed - https://www.atsjournals.org/doi/10.1513/pats.200707-090JK#:~...
Nusinersen versus Sham Control in Infantile-Onset Spinal Muscular Atrophy - https://www.nejm.org/doi/full/10.1056/nejmoa1702752

José Patrício
Portugal
Native speaker of:

Portuguese

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sham-controlled studies

Russian translation: контролируемые исследования с имитационной процедурой введения

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sham-controlled studies

Russian translation: контролируемые исследования с имитационной процедурой введения

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