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OLE (open-label extension) study

Serbo-Croat translation: otvorene metode ispitivanja

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:OLE (open-label extension) study
Serbo-Croat translation:otvorene metode ispitivanja
Entered by: V&M Stanković
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17:43 Feb 14, 2005
English to Serbo-Croat translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: OLE (open-label extension) study
clinical research study of a new treatment
xxxBojana
Local time: 05:36
otvorene metode ispitivanja
Explanation:
Otvorene metode (ispitivanja lekova), za razliku od “slepih” (placebo) metoda:


“ISPITNA PITANJA IZ FARMAKOLOGIJE I TOKSIKOLOGIJE
...
Otvorene i slepe metode ispitivanja lekova”
(www.medf.kg.ac.yu/katedre/k14/ispitna_ pitanja_iz_farmakologije_i_toksikologije.pdf )


“Department of Neurology, The University of Texas-Houston, Health Science Center
...
After the placebo-controlled extension of the pivotal US trial of glatiramer acetate for the treatment of relapsing multiple sclerosis ended, 208 participants entered an open-label, long-term treatment protocol...”
(http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d...


“Hrvatsko psihijatrijsko društvo
...
Obzirom na eticnost takve studije nisu provedene s placebo kontrolnom grupom, vec su one prospektivne, "open-label" dizajnirane.”
(http://www.hpd.htnet.hr/novosti/arhiv5.htm)
Selected response from:

V&M Stanković
Serbia
Local time: 05:36
Grading comment
Nije bas najbolje resenje posto je rec o posebnom tipu klinicke studije, ali nemam ni sama bolju ideju. Svejedno hvala puno! Puno pozdrava
3 KudoZ points were awarded for this answer

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Summary of answers provided
5otvorena produžna studija
Sladjana Daniels
4otvorena proširena metoda studija
Adnan Mustafa
4otvorene metode ispitivanja
V&M Stanković


  

Answers


7 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
ole (open-label extension) study
otvorene metode ispitivanja


Explanation:
Otvorene metode (ispitivanja lekova), za razliku od “slepih” (placebo) metoda:


“ISPITNA PITANJA IZ FARMAKOLOGIJE I TOKSIKOLOGIJE
...
Otvorene i slepe metode ispitivanja lekova”
(www.medf.kg.ac.yu/katedre/k14/ispitna_ pitanja_iz_farmakologije_i_toksikologije.pdf )


“Department of Neurology, The University of Texas-Houston, Health Science Center
...
After the placebo-controlled extension of the pivotal US trial of glatiramer acetate for the treatment of relapsing multiple sclerosis ended, 208 participants entered an open-label, long-term treatment protocol...”
(http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d...


“Hrvatsko psihijatrijsko društvo
...
Obzirom na eticnost takve studije nisu provedene s placebo kontrolnom grupom, vec su one prospektivne, "open-label" dizajnirane.”
(http://www.hpd.htnet.hr/novosti/arhiv5.htm)

V&M Stanković
Serbia
Local time: 05:36
Works in field
Native speaker of: Native in SerbianSerbian, Native in Serbo-CroatSerbo-Croat
PRO pts in category: 7
Grading comment
Nije bas najbolje resenje posto je rec o posebnom tipu klinicke studije, ali nemam ni sama bolju ideju. Svejedno hvala puno! Puno pozdrava
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2768 days   confidence: Answerer confidence 4/5Answerer confidence 4/5
ole (open-label extension) study
otvorena proširena metoda studija


Explanation:
open-label : otvorena metoda. extension:proširena. Radi se o otvorenoj proširenoj studiji. Tj. statistički uzorak je veći (proširen) u odnosu na standardni.

Adnan Mustafa
Albania
Local time: 05:36
Specializes in field
Native speaker of: Albanian
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3598 days   confidence: Answerer confidence 5/5
ole (open-label extension) study
otvorena produžna studija


Explanation:
Studija je "extension study" zato što se nadovezuje na prethodnu. U nju se pozivaju samo oni pacijenti koji su već učestvovali u prethodnoj (dakle, broj ispitanika u produžnoj studiji nikako nije povećan, može smo da bude isti ili smanjen). Ako se u prethodnoj nije znalo ko prima lek a ko placebo, u produžnoj se zna da svi primaju lek, zato je "open-label", tj. otvorena (doza može da bude maskirana).

Open label extension studies typically follow a double blind randomised placebo controlled trial of a new drug. At the end of the double blind phase, participants are invited to enrol in an extension study. The study will normally be longer than the randomised trial (two years is not uncommon but they often continue until the drug is licensed). All participants in the extension study are given the study drug, and both they and the investigators know this. The objective is primarily to gather information about safety and tolerability of the new drug in long term, day to day use.

http://www.bmj.com/content/331/7516/572

Sladjana Daniels
Serbia
Local time: 05:36
Specializes in field
Native speaker of: Serbian
PRO pts in category: 4
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