Glossary entry

English term or phrase:

no significantly and few clinically relevant drug interactions

French translation:

aucune interaction médicamenteuse significative, et peu qui soient cliniquement pertinentes

Added to glossary by FX Fraipont (X)
May 28, 2012 18:32
12 yrs ago
English term

no significantly and few clinically relevant drug interactions

English to French Medical Medical (general)
Bonjour,

Dans le cadre de la traduction d'un document de formation sur la prise en charge de la fibrillation atriale.

"Phase I studies show no food interactions and no significantly and few clinically relevant drug interactions"

Je ne vois pas comment formuler l'expression "no significantly and few clinically relevant drug interactions".

Merci pour votre aide.
Change log

Jun 11, 2012 05:02: FX Fraipont (X) Created KOG entry

Discussion

Agnes T-H May 28, 2012:
@SJLD Same thing! It works in one way ONLY (same as adverse events). The study IS relevant and proves that there actually IS a drug-drug relevant interaction
OR
The clinical trial does not prove with a significative p value (hence inferior to 0.05) that there could be interaction.
Hence there is NO reported interaction neither in the master file of the drug nor on its notice so far (II, III, IV and late phases can change that but we are specifically talking about phase I here)
In this last case there cannot be something that is "a little bit non significative". It is very significative, significative or it just does not exist. There is nothing under a non significative value. It is called a non event.

I always compare that to the state of being dead. One can be healthy, in serious state, in critical state but once they are dead they are not more dead than any other dead person.
Here, when there is a drug drug interaction it CAN be quantified on the way up (30% or 50% of the patients using the other drug at the same time) but once the level of 0.05 is passed it means that there is no interaction clinically reported.
Agnes T-H May 28, 2012:
For the document, they use "relevant" I agree but this refers to studies also. Hence the translation I have proposed. Besides, go say to any MD in France that there are "quelques rares interaction significatives" and you will immediately get a " Il y interaction ou il n'y a pas interaction mais il n'y a pas d'interaction pas ou peu significative, ça ne veut rien dire!" Again, in the "Clinical trials world" or in the "medical rep word" (I have taught so many of these in my career)... There is no such a thing as a clinically relevant interaction. There is or there is not an interaction. And this for 2 different reasons. In the Clinical Research world for the "p" reason I have explained and in the med-rep world because this interaction is or is not specified on the official label. so on one side or the other it is 0 or 1 but nothing in between.
Besides it is good to remember that we are talking about a phase I study here... Therefore it is even more a "all or nothing" question here since it will determine the exclusion/inclusion criteria of the other phases. In the exclusion criteria there will be "do not prescribe conjointly with X, Y, W"
SJLD May 28, 2012:
significant here is not meant in the statistical sense, I shouldn't think. IOW important, of note.

Authors are advised to avoid using "significant" unless they mean statistically significant.
Agnes T-H May 28, 2012:
In Clinical Research no "few relevant interaction" I think that the English is kinda mixed up here. "Few clinically relevant" refers to studies since an interaction cannot be "few clinically relevant". In clinical Research there is, or there is not, interaction. Period and here is why: A clinical trial will give you a "p" (probability of an event to occur by chance exclusively) which determine whether the study IS clinically relevant or not to prove whatever point that needs to be established. If the study is clinically relevant (with a significative "p" though) THEN the interaction exists. If the "p" is not significative, there is no clinical proof of the occurrence of such a problem.
Clinical trials are my everyday job and I have probably copied the FDA definition 20 times but here it is again the use of a "p" in a clinical trial:
p value is the probability of obtaining by chance a result at least as extreme as that observed, even when the null hypothesis is true and no real difference exists; if it is ≤ 0.05 the sample results are usually deemed statistically significant and the null hypothesis rejected."
SJLD May 28, 2012:
error in source should read: no significant and few clinically relevant drug interactions

Proposed translations

+5
42 mins
Selected

aucune interaction médicamenteuse significative, et peu qui soient cliniquement pertinentes

il me semble
Peer comment(s):

neutral Agnes T-H : Il n'existe pas d'interaction significative ou non significative. Il y a ou il n'y a pas interaction. Ce sont les résultats de l'étude clinique qui démontrent l'existence d'interaction qui sont significatifs ou pas (présence d'un "p" significatif)
9 mins
agree Isabelle F. BRUCHER (X) : Bien faire et laisser dire.... :-)
38 mins
merci!
agree Drmanu49
48 mins
merci!
agree Tristan Jimenez
13 hrs
merci!
agree Michele Lemaire : Significant makes reference to statistics -
1 day 1 hr
merci!
agree Clara Chassany
1 day 15 hrs
merci!
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "Selected automatically based on peer agreement."
-1
29 mins

Il existe peu d'études sur les interactions médicamenteuses de la molécule et ces dernières.....

Il existe peu d'études sur les interactions médicamenteuses de la (cette) molécule et ces dernières se sont révélées non significatives sur le plan des résultats cliniques....

-de la (cette) molécule peut être remplacé par le nom de la molécule en question. Si c'est un document à destination des VM (visiteurs médicaux) il est préférable de citer le nom du produit ou au moins la DCI

Source: Basic English and 17years in the pharmaceutical industry (training manager)

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Note added at 1 hr (2012-05-28 20:27:49 GMT)
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I think that the English is kinda mixed up here. "Few clinically relevant" refers to studies since an interaction cannot be "few clinically relevant". In clinical Research there is, or there is not, interaction. Period and here is why: A clinical trial will give you a "p" (probability of an event to occur by chance exclusively) which determine whether the study IS clinically relevant or not to prove whatever point that needs to be established. If the study is clinically relevant (with a significative "p" though) THEN the interaction exists. If the "p" is not significative, there is no clinical proof of the occurrence of such a problem.
Clinical trials are my everyday job and I have probably copied the FDA definition 20 times but here it is again the use of a "p" in a clinical trial:
p value is the probability of obtaining by chance a result at least as extreme as that observed, even when the null hypothesis is true and no real difference exists; if it is ≤ 0.05 the sample results are usually deemed statistically significant and the null hypothesis rejected."
It means that with a p value ≤ 0.05 There IS an interaction with such and such other molecule, if p value is >0.05 there is NO interaction with such and such molecule.
There is no in-between here.

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Note added at 4 hrs (2012-05-28 22:48:20 GMT)
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@Anaig: Parce que "peu" ne peut pas se rapporter à l’interaction. Prenez n'importe quel Dictionnaire Vidal (vous bossez dans un labo je crois donc vous n'aurez aucun mal) et vous constaterez qu'il n'y a que deux possibilité. Il y interaction médicamenteuse ou pas. Ça aboutit a une contre-indication absolue (interaction cliniquement très significative et dangereuse) ou juste a une précaution d'emploi (interaction cliniquement significative)
J'ai coutume de comparer ça à la grossesse (ou à la mort).. On est enceinte ou on ne l'est pas. On peut être "presque à terme" mais en aucun cas une femme est "presque enceinte" ou "peu significativement" enceinte!
En clair, soit l'interaction médicamenteuse est TRES significative et dans ce cas ça donne lieu à une "contre-indication absolue", ou elle est juste significative et dans ce cas on demande au prescripteur d'observer des "précautions d'emploi" (par exemple on ajuste la prescription en fonction de la clairance à la créatinine) .
Une fois qu'on a passé le niveau du p>0.05 ça veut dire qu'il n'y a PAS d'interaction et il n'y a pas de graduation au dessus de cette valeur... Pour tout médecin ou pharmacien, en dessous de cette valeur l'interaction n'existe tout simplement PAS et elle ne figure nulle part dans le dossier du produit et nulle part sur le Vidal.

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Note added at 4 hrs (2012-05-28 22:48:50 GMT)
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PossibilitéS*

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Note added at 4 hrs (2012-05-28 22:50:24 GMT)
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Dessus* (pas dessous quoi que ça dépend du sens de l'étude)
Note from asker:
Cela correspond-il réellement au texte source ? Pourquoi évoquez-vous le "peu d'études" dans la traduction ? Merci bien. :)
Peer comment(s):

neutral Tony M : But that distorts the source text, since it specifically says "Phase I studies..."
12 mins
There is not enough room to write everything and it would have cut too much of the sentence for it to make sense. So"Phase I studies " yes
disagree Marc-André Laniel : Wrong interpretation. As SJLD points out, they're not using significant in the statistical sense, but as a synonym of important.
6 hrs
If this was not clinical trial (statistically) related phase I won't be specified. &the "force" of 1 interaction cannot evaluated in phase 1 since the aim of this phase is ONLY to assess the safety at highest doses than normal treatment on about 20 Ppl!
neutral GILLES MEUNIER : OHHH Agnès
5 days
Yep! C'est fun car le "p" dont je parle est repris + loin ds le texte (donc j'ai raison ça doit bien se comprendre sur le plan statistique). Quant aux réponses....Que veux-tu: tant que la "science" des non pro n'aura pas provoqué de vraie catastrophe...
Something went wrong...
1 day 16 hrs

aucune interaction significative de medicaments et quelques unes cliniquement appropriees

none of the drug interactions are significant. hence we use 'aucune' and we use 'quelques unes' for 'some' which is in agreement with the word 'interactions'.
Something went wrong...
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