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pivotal trial

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16:35 Aug 30, 2006
This question was closed without grading. Reason: No acceptable answer

English to Polish translations [PRO]
Medical - Medical: Instruments / badania kliniczne
English term or phrase: pivotal trial
Nie chodzi o "badanie przełomowe", lecz o odpowiednik badania III fazy w przypadku leku.
Marek Koprowski
Local time: 01:10
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Summary of answers provided
4 +1przedrejestracyjne
MStanicki
3próba kluczowa
Marquis
3 -1szerokie badania prowadzone równocześnie w wielu ośrodkachA.G.
Summary of reference entries provided
ref.Polangmar

Discussion entries: 3





  

Answers


20 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
próba kluczowa


Explanation:
imho

Marquis
United States
Local time: 18:10
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in PolishPolish
PRO pts in category: 15
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18 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): -1
szerokie badania prowadzone równocześnie w wielu ośrodkach


Explanation:
multicenter (PIVOT) trial involving 180 of 240. SPK patients compared 2 dosing regimens of da- ... PIVOT trial not only randomized 2 groups of pa- ...
gft.sagepub.com/cgi/reprint/4/7/500.pdf - Podobne strony

A major clinical trial (the so-called PIVOT trial) has been organized in order to attem

A.G.
Local time: 01:10
Native speaker of: Native in PolishPolish
PRO pts in category: 81

Peer comments on this answer (and responses from the answerer)
disagree  MStanicki: "multi-center" to nie to samo co pivotal. I PIVOT (z linku powyżej) to również nie to samo co "pivotal".
3423 days
  -> w dyskusji

neutral  Polangmar: Pivotal trials mogą, oczywiście, być wieloośrodkowe, ale zdecydowanie nie o to w przedmiotowym termininie chodzi.
3856 days
  -> Od 433 dni już to (pivot vs. pivotal) wiem. Dziękuję za przypomnienie
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3424 days   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
przedrejestracyjne


Explanation:
więcej informacji w polu "dyskusja"

MStanicki
Poland
Local time: 01:10
Native speaker of: Native in PolishPolish
PRO pts in category: 8

Peer comments on this answer (and responses from the answerer)
agree  Polangmar: Dodałbym jednak "główne" (główne przedrejestracyjne badania kliniczne), bo fazy 1 i 2 też są, formalnie rzecz biorąc, przedrejestracyjne.
432 days
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Reference comments


3856 days
Reference: ref.

Reference information:
The primary goal of phase 1 trial is to collect data about safety, a safe dosage range in the case of medications and identify side effects of a treatment. (...) In phase II, the researcher will continue with the exploration of potential toxicity and search for evidence of effectiveness. (...) Phase 3 trials, also known as pivotal clinical trials, should provide final proof that examined methods are effective with the acceptable profile of unwanted events. In industry, successful phase 3 trials lead to marketing approval of medication or device.
http://www.clinicaltrial.co/BasicStatistics/StudiesByPhase

Dotychczas dominowały badania przedrejestracyjne, tzw. trzeciej fazy. Wczesne [tzn. I i II - przyp. mój] fazy badań służą ocenie bezpieczeństwa stosowania leków oraz ustaleniu dawki terapeutycznej.
http://gazetalekarska.pl/?p=28888

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Note added at 3856 days (2017-03-22 16:21:52 GMT)
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Dotychczas były to przede wszystkim badania przedrejestracyjne, III fazy, generujące największe wpływy finansowe dla państwa.
https://ceo.com.pl/badania-kliniczne-klucz-do-postepu-w-medy...

Polangmar
Poland
Native speaker of: Native in PolishPolish
PRO pts in category: 574
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