Glossary entry (derived from question below)
French term or phrase:
etude pivotale
English translation:
pivotal trial
French term
etude pivotale
| 3 +8 | pivotal trial |
mimi 254
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| 4 +4 | pivotal study |
Nikki Scott-Despaigne
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| 3 | pivotal clinical study |
Roy vd Heijden
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Non-PRO (2): SJLD, Michael Barnett
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Proposed translations
pivotal trial
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Note added at 15 mins (2011-12-19 13:49:20 GMT)
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www.abroadlink.com/.../Pharmacology Writing for French-Engl...
www.linguee.fr/anglais-francais/traduction/pivotal trial.ht...
wiki.answers.com/Q/What_is_a_pivotal_clinical_trial - Cached
pivotal clinical trial/study
www.prnewswire.com/.../inspiration-biopharmaceuticals-initi...
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philgoddard
: Of course.
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SJLD
1 hr
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Thanks
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Michael Lotz
3 hrs
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Thanks!
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Drmanu49
5 hrs
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Thanks!
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NancyLynn
5 hrs
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Thanks!
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Michael Barnett
: Hi. The term "pivotal trial" turned up recently in the Eng>Eng section. There was more discussion than I would have expected about what it means.
5 hrs
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marie-christine périé
7 hrs
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ACOZ (X)
11 hrs
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Thanks!
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Psychologist, Court-certified legal
Native in: English 
Works in: French to English
pivotal study
“Etude pivotale” is synonymous with “étude cardinale”, the preferred term (?), the former probably being a claque on the English, “pivotal study”.
http://textes.droit.org/JORF/2008/09/06/0208/0081/
étude cardinale
Domaine : Santé et médecine/Pharmacologie.
Voir : étude pivot.
étude pivot
Domaine : Santé et médecine/Pharmacologie.
Synonyme : étude cardinale.
Définition : Étude de référence, notamment dans le cadre d'une recherche.
Note : L'expression étude pivotale » est déconseillée.
Équivalent étranger : pivotal study.
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Note added at 15 mins (2011-12-19 13:49:10 GMT)
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http://www.nexavar-international.com/home/hcp_nexavar_hcc/pi...
« Pivotal study : the SHARP trial.
Nexavar — Proven Efficacy and Manageable Safety Profile in the SHARP Trial
SHARP: Sorafenib HCC Assessment Randomized Protocol Trial
A randomised, double-blind, placebo-controlled, international, multicentre, phase III study in patients with HCC1,9”
http://www.trimelpharmaceuticals.com/Newsroom/NewsArchives/N...
“Trimel Pharmaceuticals Corporation Announces
Commencement of CompleoTRT U.S. Phase III Study
Toronto, Canada, September 13, 2011 – Trimel Pharmaceuticals Corporation (TSX: TRL) (the “Company” or “Trimel”) announced today that it has submitted its final study protocol to the Food and Drug Administration (FDA) and has received ethics board approval thereby clearing the way for the Company to initiate the pivotal Phase III study for Trimel’s lead product CompleoTRT. The Company intends to now move forward with patient recruitment at over 30 sites in the United States and expects patient dosing to commence in the coming weeks. The Phase III study will represent the final stage of product development prior to Trimel submitting a New Drug Application (NDA) to the FDA for marketing approval in the United States.
“The start of the CompleoTRT Phase III pivotal study is a major milestone for our Company” said Bruce D. Brydon, Chairman and Chief Executive Officer of Trimel. “There are few if any start-up companies that have progressed from inception to commencing a Phase III study in less than three years.””
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Michael Lotz
3 hrs
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Drmanu49
4 hrs
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marie-christine périé
7 hrs
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Hal D'Arpini
: "Study" is the better word here, absent more context indicating that the subterm "trial" should be used. Otherwise, "essai" would have been the word used in the ST I should thing.
1 day 6 hrs
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Belgium
modo possem penitus deliberare
Native in: Dutch (Variant: Netherlands) 
Works in: French to Dutch
pivotal clinical study
Ex.:
“Ipsen’s partner Inspiration Biopharmaceuticals announces the initiation of the second phase III pivotal clinical study of OBI-1 in congenital hemophilia A with inhibitors”
(http://www.businesswire.com/news/home/20111127005040/en)
« Le partenaire d’Ipsen, Inspiration Biopharmaceuticals, initie la seconde étude pivotale de phase III avec OBI-1 dans l’hémophilie congénitale de type A avec inhibiteurs »
(http://www.businesswire.com/news/home/20111127005039/fr)
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