Mar 1, 2009 13:37
15 yrs ago
7 viewers *
English term
Germany
Medicine & Science: translations+writing
Native in: German 
Works in: English to German, German
discontinuation of a subject from a study vs. premature discontinuation of the study drug
English to German
Medical
Medical: Pharmaceuticals
summary of clinical trials
I have got a problem here concerning the understanding of the difference in the meaning of "discontinuation of a subject from a study" and "premature discontinuation of the study drug".
There are two sentences about adverse effects in the described clinical trials, that lead to discontination. The sentences are very similar, but there has to be some difference in the meaning:
"In the active-controlled multicenter studies the overall incidence of adverse events resulting in discontinuation of a subject from a study was 1.3% in group A, 1.8% in group B and 4.1% in group C. In the same studies, the overall incidence of adverse events resulting in premature discontinuation of the study drug was 1.6% in group A, 3.0% in the group B and 2.1% in group C."
Does anybody know the difference? Thank you very much for your help!
Best regards,
Johanna
There are two sentences about adverse effects in the described clinical trials, that lead to discontination. The sentences are very similar, but there has to be some difference in the meaning:
"In the active-controlled multicenter studies the overall incidence of adverse events resulting in discontinuation of a subject from a study was 1.3% in group A, 1.8% in group B and 4.1% in group C. In the same studies, the overall incidence of adverse events resulting in premature discontinuation of the study drug was 1.6% in group A, 3.0% in the group B and 2.1% in group C."
Does anybody know the difference? Thank you very much for your help!
Best regards,
Johanna
Proposed translations
(German)
| 3 +9 | Vorzeitiges Ausscheiden des Teilnehmers aus der Studie vs. vorzeitiges Absetzen des Prüfpräparates |
Andrea Winzer
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Change log
Mar 1, 2009 14:50: Steffen Walter changed "Term asked" from "\"discontinuation of a subject from a study\" vs. \"premature discontinuation of..\"" to "discontinuation of a subject from a study vs. premature discontinuation of the study drug"
Proposed translations
+9
59 mins
Andrea Winzer
United States
United States
Native in German
Works in field
United States
Top Quality: Fast, reliable & certified
Native in: German
Works in: English to German, German to English, Latin to German, and 1 more.
Related KudoZ points
:
52
English term (edited):
"discontinuation of a subject from a study" vs. "premature discontinuation of.."
Selected
Vorzeitiges Ausscheiden des Teilnehmers aus der Studie vs. vorzeitiges Absetzen des Prüfpräparates
Das vorzeitige Ausscheiden aus der Studie kann verschiedene Gründe haben (siehe "Discontinuation")
http://www.ata-divisions.org/GLD/docs/48_konferenz/Glossary_...
http://www.ata-divisions.org/GLD/docs/48_konferenz/Glossary_...
Note from asker:
| Hallo Andrea! In diese Richtung habe ich auch gedacht, war aber nicht so sicher, vielen Dank für den guten Vorschlag! |
Peer comment(s):
| agree |
Steffen Walter
: Ja.
13 mins
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Danke, Steffen :))
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| agree |
Kitty Maerz
24 mins
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Danke, Kitty :))
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| agree |
Sabine Akabayov, PhD
55 mins
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Thank you :))
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| agree |
Marga Shaw
: Ja! Es fiel mir aber gerade auf, dass ich oben unter "Diskussion" aus dem gleichen Glossar zitiert habe. Tut mir leid!
56 mins
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Danke, Marga :)) Kein problem - das ATA-Glossar ist ja in diesem Kontext eine der besten Referenzen :))
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| agree |
eva maria bettin
2 hrs
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Dankeschön :))
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| agree |
Cetacea
: So verstehe ich das auch.
3 hrs
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Danke, Cetacea :))
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| agree |
Siegfried Armbruster
: genau
5 hrs
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| agree |
Harald Moelzer (medical-translator)
14 hrs
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| agree |
Silvia Koch
18 hrs
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4 KudoZ points awarded for this answer.
Comment: "Vielen Dank an alle!"
Discussion
In einem Glossar zu klinischen Prüfungen fand ich die folgende Definition:
Vorzeitiges Ausscheiden aus der Studie - Beenden der Teilnahme an der Studie vor Abschluss der nach dem Protokoll (Prüfplan) geforderten Elemente: Vier Kategorien: 1. Dropout: aktives Ausscheiden (Entschluss des Patienten), 2. Entschluss des Prüfarztes (vorhandener Grund), 3. Patient ist nicht zu Untersuchungen erschienen, 4. Entschluss des Sponsors.
(Die vorstehenden Punkte werden aber meist ausführlich im jeweiligen Prüfplan besprochen.)
Im ersten Fall entscheidet der Proband selbst, im zweiten Fall
haben "nachteilige Ereignisse" das Absetzen des Präparats notwendig gemacht.