AW: Re: EN>FR registration trial

[Guest guest]

Sue,

As explained before a registration trial is a clinical study necessary for

obtaining the marketing authorisation of a drug/device. The individual

requirements for registration trials vary greatly, depending on the

drug/device and indication. While such studies are very often Phase III

studies, this is no requirement for such a study. Moreover, most studies

conducted for this purpose are at least single blind.

As mentioned before, I am not sure about the correct French term for

registration trial, but “PhaseIIIb – essai ouvert” is misleading.

A.

_____

Von: medical_translation

[mailto:medical_translation ] Im Auftrag von Sue Levy

Gesendet: Tuesday, January 09, 2007 10:04 PM

An: medical_translation

Betreff: Re: EN>FR " registration trial "

essai de phase IIIb - essai ouvert

>

> Des idées pour ce type d'essai clinique ? En faisant des recherches,

> j'ai trouvé une indication venant d'un autre forum, traduit par essai

> par recrutement individuel, mais je n'ai jamais rencontré cette

> expression et préfère donc avoir d'autres avis .........D'avance

merci

> à tous

>