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critères d'évaluation cliniques durs

English translation: hard endpoints

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:critères d'évaluation cliniques durs
English translation:hard endpoints
Entered by: tinamenon
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14:33 Mar 25, 2007
French to English translations [PRO]
Medical - Medical: Cardiology
French term or phrase: critères d'évaluation cliniques durs
Talking about how diuretics help to lower BP in the elderly and they say that thes studies are based on ... "...avec des études basées sur des critères d'évaluation cliniques durs"

It's the word 'dur' that particularly throws me!

based on (hard/solid) clinical criteria/evidence/assessment
tinamenon
Local time: 21:08
hard endpoints
Explanation:
This is to elaborate on Dr. Peterson's quite correct translation.
The term "hard endpoint" is used in contradistinction to "surrogate endpoint".

See Wikipedia's explanation:
In clinical trials, a surrogate endpoint is a measure of effect of a certain treatment that may correlate with a real endpoint but has no guaranteed relationship.

It is a major issue in testing the efficacy of medication. For example, most cholesterol-lowering drugs (e.g. the statins) are used to control cardiovascular disease, yet they were introduced with only information on their capacity to decrease cholesterol levels. While elevated cholesterol levels increase the likelihood for heart disease, the relationship is not linear - many people with normal cholesterol develop heart disease, and many with high cholesterol do not. In the case of simvastatin (Zocor®), proof of its efficacy in reducing cardiovascular disease was only presented five years after its original introduction, and then only for secondary prevention. In another case, AstraZeneca has been accused of marketing rosuvastatin (Crestor®) without providing hard endpoint data, relying instead on surrogate endpoints. The company counters that it had been tested on larger groups of patients than any other drug in the class, and that its effects should be comparable to the other statins.

Back to my own explanation.
Say you are evaluating a medicine for stomach ulcers. One might think that proof that a medicine raises the pH of the stomach contents is proof that it helps prevent ulcers. Well, maybe it does and maybe it doesn't. The stomach contents acidity is in fact a "surrogate endpoint". The "hard endpoint" would be the actual development of an ulcer vs the absence of an ulcer after a fixed period of time. A "hard endpoint" is preferable in any clinical trial.
Selected response from:

Michael Barnett
Local time: 16:08
Grading comment
Many thanks for your very clearly explained answer
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +3hard clinical endpointsDr. Karina Peterson
4 +2hard endpoints
Michael Barnett
4 +1solid clinical outcomes
hduverle
4 +1solid clinical evidence
Drmanu49
4hard clinical evaluation criteriaJock


  

Answers


2 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
solid clinical evidence


Explanation:
The Journal advocates the use or rejection of a procedure based on solid, clinical evidence found in literature. The Journal's dynamic operating principles ...
www.elsevier.com/wps/find/authored_newsitem.cws_home/compan... - 46k -

--------------------------------------------------
Note added at 3 minutes (2007-03-25 14:37:15 GMT)
--------------------------------------------------

or reliable clinical evidence

Lack of reliable clinical evidence for or against direct and indirect veneers. When patients' anterior teeth are stained, is direct or indirect veneer ...
www.nature.com/ebd/journal/v5/n2/full/6400248a.html

Drmanu49
France
Local time: 22:08
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 353

Peer comments on this answer (and responses from the answerer)
agree  Sheila Wilson
22 mins
  -> Thank you Sheila
Login to enter a peer comment (or grade)

6 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
solid clinical outcomes


Explanation:
could be a good idea
outcome is usually the "critère d'évaluation" in a clinical study

http://www.medscape.com/viewarticle/496102_40
So we need to be sure, before these agents are widely used in patients, that we have very good evidence that they are safer than the other alternatives. I think that this means we need solid clinical outcome studies where the comparators are the safest known alternatives, and the safety must be demonstrated across a broad class of outcomes.

hduverle
Local time: 16:08
Specializes in field
Native speaker of: Native in FrenchFrench
PRO pts in category: 12

Peer comments on this answer (and responses from the answerer)
agree  Swatchka
28 mins
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
hard clinical evaluation criteria


Explanation:
"Clinical evaluation criteria" est très répandu.

Jock
Local time: 22:08
Native speaker of: Native in FrenchFrench
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
hard endpoints


Explanation:
This is to elaborate on Dr. Peterson's quite correct translation.
The term "hard endpoint" is used in contradistinction to "surrogate endpoint".

See Wikipedia's explanation:
In clinical trials, a surrogate endpoint is a measure of effect of a certain treatment that may correlate with a real endpoint but has no guaranteed relationship.

It is a major issue in testing the efficacy of medication. For example, most cholesterol-lowering drugs (e.g. the statins) are used to control cardiovascular disease, yet they were introduced with only information on their capacity to decrease cholesterol levels. While elevated cholesterol levels increase the likelihood for heart disease, the relationship is not linear - many people with normal cholesterol develop heart disease, and many with high cholesterol do not. In the case of simvastatin (Zocor®), proof of its efficacy in reducing cardiovascular disease was only presented five years after its original introduction, and then only for secondary prevention. In another case, AstraZeneca has been accused of marketing rosuvastatin (Crestor®) without providing hard endpoint data, relying instead on surrogate endpoints. The company counters that it had been tested on larger groups of patients than any other drug in the class, and that its effects should be comparable to the other statins.

Back to my own explanation.
Say you are evaluating a medicine for stomach ulcers. One might think that proof that a medicine raises the pH of the stomach contents is proof that it helps prevent ulcers. Well, maybe it does and maybe it doesn't. The stomach contents acidity is in fact a "surrogate endpoint". The "hard endpoint" would be the actual development of an ulcer vs the absence of an ulcer after a fixed period of time. A "hard endpoint" is preferable in any clinical trial.

Michael Barnett
Local time: 16:08
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 116
Grading comment
Many thanks for your very clearly explained answer

Peer comments on this answer (and responses from the answerer)
agree  Dr. Karina Peterson: Thank you for your explanations.
3 mins
  -> Thanks Karina.

agree  hduverle: endoint! of course.... could not catch the word that day :O)
8 days
  -> Merci Herve!
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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
hard clinical endpoints


Explanation:
Il me semble que c'est le terme approprié.

--------------------------------------------------
Note added at 2 hrs (2007-03-25 16:41:05 GMT)
--------------------------------------------------

Oui Michael d'ailleurs en français il me semble que les termes "critères de jugement" sont plus appropriés.


    Reference: http://www.md.ucl.ac.be/loumed/CD/DATA/117/S275-278.PDF
    www.spc.univ-lyon1.fr/polycop/principes de base/chapitre.htm
Dr. Karina Peterson
Local time: 16:08
Specializes in field
Native speaker of: French

Peer comments on this answer (and responses from the answerer)
agree  Helen Genevier
25 mins
  -> Merci Helen

agree  Michael Barnett: See my answer for further amplification.
39 mins
  -> Merci Michael

agree  Dr Sue Levy: coucou Karina!
1 hr
  -> Merci Sue et bon dimanche!
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