Glossary entry (derived from question below)
English term or phrase:
modified double-blind trial
French translation:
essai en double aveugle modifié
Added to glossary by
PLR TRADUZIO (X)
Jan 19, 2013 19:16
11 yrs ago
1 viewer *
English term
modified double-blind trial
English to French
Medical
Medical (general)
étude clinique
A phase 3, randomized, active-controlled, modified double-blind trial, Study 3005, was conducted to assess the safety, tolerability, and immunogenicity of XXXX at various sites in the Unites States and Sweden.
OK pour essai en double aveugle modifié (si c'est bien ça) mais en quoi cela consiste-t-il par rapport à un essai en double aveugle non modifié ?
OK pour essai en double aveugle modifié (si c'est bien ça) mais en quoi cela consiste-t-il par rapport à un essai en double aveugle non modifié ?
Proposed translations
(French)
| 4 +4 | essai en double aveugle modifié |
PLR TRADUZIO (X)
|
Change log
Feb 9, 2013 18:02: PLR TRADUZIO (X) Created KOG entry
Proposed translations
+4
2 hrs
Selected
essai en double aveugle modifié
Le protocole a été modifié
http://www.clinresearch.info/research/index/NCT00427895
This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). **********************Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. *************************Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.
http://www.clinresearch.info/research/index/NCT00427895
This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). **********************Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. *************************Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.
4 KudoZ points awarded for this answer.
Comment: "Merci à tous"
Reference comments
9 mins
Reference:
see
www.med.univ-montp1.fr/.../MB6_Epidémio_RC... - Translate this page
File Format: PDF/Adobe Acrobat - Quick View
maintien de la comparabilité des groupes dans les essais comparatifs .... (possibilité de modifier l'AMM) ..... Mener l'essai en «double aveugle» (ou double insu) ...
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Note added at 13 mins (2013-01-19 19:29:50 GMT)
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http://jama.jamanetwork.com/article.aspx?articleid=1182869#q...
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Note added at 16 mins (2013-01-19 19:33:24 GMT)
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from one site:
"...in a traditional clinical trial a protocol is developed and executed with no modifications - ideally"
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Note added at 18 mins (2013-01-19 19:35:01 GMT)
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from this site:
http://digital.findpharma.com/nxtbooks/advanstar/act_200909/...
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Note added at 20 mins (2013-01-19 19:37:10 GMT)
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essais cliniques + annexes - Leem
www.leem.org/sites/default/files/.../104_1211.pdf - Translate this page
File Format: PDF/Adobe Acrobat - Quick View
clinique est éthique et que les droits des participants à l'étude sont protégés. 2. Un protocole d'essais cliniques peut-il être modifié ? Par qui ? Avec quel ...
File Format: PDF/Adobe Acrobat - Quick View
maintien de la comparabilité des groupes dans les essais comparatifs .... (possibilité de modifier l'AMM) ..... Mener l'essai en «double aveugle» (ou double insu) ...
--------------------------------------------------
Note added at 13 mins (2013-01-19 19:29:50 GMT)
--------------------------------------------------
http://jama.jamanetwork.com/article.aspx?articleid=1182869#q...
--------------------------------------------------
Note added at 16 mins (2013-01-19 19:33:24 GMT)
--------------------------------------------------
from one site:
"...in a traditional clinical trial a protocol is developed and executed with no modifications - ideally"
--------------------------------------------------
Note added at 18 mins (2013-01-19 19:35:01 GMT)
--------------------------------------------------
from this site:
http://digital.findpharma.com/nxtbooks/advanstar/act_200909/...
--------------------------------------------------
Note added at 20 mins (2013-01-19 19:37:10 GMT)
--------------------------------------------------
essais cliniques + annexes - Leem
www.leem.org/sites/default/files/.../104_1211.pdf - Translate this page
File Format: PDF/Adobe Acrobat - Quick View
clinique est éthique et que les droits des participants à l'étude sont protégés. 2. Un protocole d'essais cliniques peut-il être modifié ? Par qui ? Avec quel ...
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