Glossary entry

English term or phrase:

open-label extensions

French translation:

extension (des essais/études) en mode de test ouvert

Added to glossary by Francis MARC
Dec 21, 2002 17:16
21 yrs ago
4 viewers *
English term

open-label extensions

English to French Medical Alzheimer
only donepezil has long-term data from sources other than open-label extensions, therefore, the results of the open-label extensions are discussed

open-label trials = essais ouverts, mais comment traduire "extension" ? (des essais ouverts qui viennent se greffer aux essais régulièrs ??)


Un grand merci d'avance !

Proposed translations

30 mins
Selected

extension/poursuite (des essais/études) en mode de test ouvert

après des séries d'essai souvent à l'aveugle, en placébo (les patients ne savent pas ce qu'ils prennent, ou ils croient prendre la même chose)les tests se poursuivent à échelle plus large avec connaissance du traitement réel par tous.

http://www.amylin.com/website/Pipeline/Symlin.htm
Additionally, we completed two longer term open-label safety studies and open- label extensions of the Phase 3 placebo-controlled studies to assess longer-term effects of SYMLIN. In open-label studies, all participants receive study drug. Our Phase 3 studies are summarized below.
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4 KudoZ points awarded for this answer. Comment: "merci ! Joyeux Noël et Bonne Année !"
+2
22 mins

prolongations d'essais ouverts

... Le professeur Kalden et ses collègues ont annoncé les résultats tirés de la prolongation d'un essai ouvert multicentrique d'une durée de cinq ans. ...

http://cl02.cyperus.fr/cyperusfr/Fr/PressRelease.nsf/PressRe...
Peer comment(s):

agree Martine Ascensio
1 hr
Merci
agree John Garside
1 hr
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+1
1 hr

utilisation hors AMM (Autorisation de Mise sur le Marche)

Simply.
Term often used by Drs. themselves. Now I don't know if it is 'colloquial medical terminology' or the proper technical terminology. I think that would be splitting hairs though.
An 'AMM' represents the indications that the product is officially (legally) licensed for, but often, trials haven't been finished, (some trials last years), and the product may be used, off-label, (not licensed) for a particular indication (pathology)where it is likely to be effective, although not yet 'proven' effective through trials.
Hope this helps.

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Note added at 2002-12-21 18:24:29 (GMT)
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In other words, I wouldn\'t translate \'extension\'.
Peer comment(s):

agree cjohnstone
42 mins
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