critères d'évaluation cliniques durs
English translation: hard endpoints
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| 14:33 Mar 25, 2007 |
| French to English translations [PRO] Medical - Medical: Cardiology | |||||||
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|  Selected response from: Michael Barnett Local time: 19:05 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 4 +3 | hard clinical endpoints |
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| 4 +2 | hard endpoints |
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| 4 +1 | solid clinical evidence |
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| 4 +1 | solid clinical outcomes |
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| 4 | hard clinical evaluation criteria |
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Answers
2 mins confidence: 
peer agreement (net): +1
peer agreement (net): +1solid 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 |
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6 mins confidence: peer agreement (net): +1
peer agreement (net): +1solid 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. |
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1 hr confidence:
hard clinical evaluation criteria Explanation: "Clinical evaluation criteria" est très répandu. |
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1 hr confidence: peer agreement (net): +2
peer agreement (net): +2hard 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. |
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Grading comment
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1 hr confidence: peer agreement (net): +3
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