Zulassungstudie

English translation: pivotal study

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
German term or phrase:Zulassungstudie
English translation:pivotal study
Entered by: Lirka

01:42 Mar 1, 2021
German to English translations [PRO]
Medical - Medical: Health Care
German term or phrase: Zulassungstudie
I did not get a clear answer on this from previous Qs, so I am re-posting. What is a Zulassungstudie in English:
1. Pivotal trial
2. Label-enabling trial
3. Registration study
4.?

My context is as follows:

" In den Phase-III-Zulassungsstudien [name of study] und [name of study] zeigte X im Vergleich mit Y eine Nicht-Unterlegenheit."

Thank you!
Lirka
Austria
Local time: 11:19
pivotal study
Explanation:
Among your choices, "pivotal" is the term I have encountered most often (for EMA approvals).
Intuitively, I would associate "registration study" with FDA filing, but I have no proof for that (and currently no time to research this, sorry!)
Selected response from:

Anne Schulz
Germany
Local time: 11:19
Grading comment
Thank you! I used pivotal, I hope the proofreader and client will not insist on a more literal version :=
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +8pivotal study
Anne Schulz
3 +3approval study/procedure
David Hollywood
4 +1clinical trial
Lancashireman
1non-inferiority trial / noninferiority trial
andres-larsen
Summary of reference entries provided
Kim Metzger

Discussion entries: 11





  

Answers


1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
clinical trial


Explanation:
https://www.nccn.org/patients/resources/clinical_trials/phas...

Lancashireman
United Kingdom
Local time: 10:19
Native speaker of: Native in EnglishEnglish
PRO pts in category: 67

Peer comments on this answer (and responses from the answerer)
agree  thefastshow: Given the source (Phase III Zulassungsstudie) this is the most suitable answer! (Phase III clinical trial)
6 hrs
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1 hr   confidence: Answerer confidence 1/5Answerer confidence 1/5
non-inferiority trial / noninferiority trial


Explanation:
Point to consider on switching between superiority and non ...
www.ema.europa.eu › documents › scientific-guideline
PDF
II.3. Non-inferiority trial. In Phase III drug development, non-inferiority trials are more common than equivalence trials. In these we wish to show that a new ...

Non-Inferiority Clinical Trials to Establish Effectiveness ... - FDA
www.fda.gov › media › download
PDF
III. GENERAL CONSIDERATIONS FOR NON-INFERIORITY STUDIES . ... The determination of M1 is a critical step in designing an NI trial and is often difficult; ...

A Phase III, randomized, non-inferiority trial, to assess ... - PLOS
journals.plos.org › plosone › article › file › journal.pon...
PDF
Page 1 of 14. Amendment N°: 3. Protocol N°: ST3073-ST3074 DM040010. Title: A Phase III, randomized, non-inferiority trial, to assess the efficacy and safety of.

Noninferiority Trial - an overview | ScienceDirect Topics
www.sciencedirect.com › topics › n...·
Noninferiority trials are common in comparing treatments that have been ... open, randomized, active control, phase III, non-inferiority trial for 10 days in the ...

Superiority, Non-inferiority and Equivalence - The Phase III ...
www.akronbiotech.com › 2019/11
In short, Phase III trials are devised to determine superiority or non-inferiority or equivalence. The objective of a Phase III trial must be defined up front; is the end ...

Superiority and Non-inferiority Phase III Oncology Trials ...
link.springer.com › chapter › 978-3-319-71324-3_12
17 abr. 2018 - Most phase III trials in oncology aim to demonstrate the superiority of a new treatment in comparison with control, but so-called non-inferiority phase III trials assess whether a more convenient, less toxic, or more affordable intervention is at least as efficacious as an existing standard of care.


andres-larsen
Venezuela
Local time: 06:19
Native speaker of: Native in EnglishEnglish
PRO pts in category: 19
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1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +3
approval study/procedure


Explanation:
Are post-approval studies the same as “observational studies”? An observational study in clinical research is a non ...
Nov 9, 2020 · Uploaded by European Society of Cardiology

--------------------------------------------------
Note added at 1 hr (2021-03-01 03:34:56 GMT)
--------------------------------------------------

I think "approval" is the key here

David Hollywood
Local time: 07:19
Native speaker of: English
PRO pts in category: 102
Notes to answerer
Asker: Thanks, David. I agree that some clients may prefer this version, b ut pivotal seems to be the right term for my phase-III context!


Peer comments on this answer (and responses from the answerer)
agree  Brent Sørensen: I generally use “pivotal study”; however, some clients have expressly asked me to use “approval study”
1 hr

agree  Manuela Junghans: or "pivotal study"
5 hrs

agree  Glenn Brigaldino: Approval is best, pivotal is not indicated. Should however be the plural, "Studien".
20 hrs
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4 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +8
pivotal study


Explanation:
Among your choices, "pivotal" is the term I have encountered most often (for EMA approvals).
Intuitively, I would associate "registration study" with FDA filing, but I have no proof for that (and currently no time to research this, sorry!)

Anne Schulz
Germany
Local time: 11:19
Works in field
Native speaker of: German
PRO pts in category: 179
Grading comment
Thank you! I used pivotal, I hope the proofreader and client will not insist on a more literal version :=
Notes to answerer
Asker: Klasse, danke, Anne! :=


Peer comments on this answer (and responses from the answerer)
agree  Brent Sørensen
48 mins
  -> Thanks Brent :-) and sorry - it seems I missed your proposing "pivotal" in David's answer when I posted mine (although I was sure to have read the whole tableau at the time)

agree  Susanne Schiewe
2 hrs
  -> Danke Susanne :-)

agree  Manuela Junghans: or "approval study"
2 hrs
  -> Danke Manuela :-) Klar, approval study ist auch ok. Obwohl ich – wieder rein "vom Gefühl her" andererseits sagen würde, dass mir diese Kombination zumeist in "post approval studies" untergekommen ist.

neutral  thefastshow: pivotal study usually refers to the phase III trial of a clinical trial or in laymans term approval study. Also see here https://en.wikipedia.org/wiki/Pivotal_trial // Anm. unter Discussion
4 hrs
  -> I am afraid I don't understand your concern. The wikipedia definition of pivotal trial is pretty much the same as the definition Kim quoted for Zulassungsstudie in his reference below, isn't it?

agree  Harald Moelzer (medical-translator)
6 hrs
  -> Danke Harald :-)

agree  Marga Shaw
7 hrs
  -> Danke Marga :-)

agree  Steffen Walter: @thefastshow This is exactly what this question is about according to the context: a phase III trial.
14 hrs
  -> Danke Steffen :-) Ich verstehe den Einwand ehrlich gesagt auch nicht.

agree  Johanna Timm, PhD
19 hrs
  -> Danke Johanna :-)

agree  Kim Metzger: https://en.wikipedia.org/wiki/Pivotal_trial
1 day 7 hrs
  -> Thanks Kim :-))
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Reference comments


3 hrs peer agreement (net): +3
Reference

Reference information:
Eine Zulassungsstudie ist eine klinische Studie, die dazu dient, die Zulassung eines neuen Arzneimittels zu erwirken, oder den Einsatz eines bereits zugelassenen Arzneimittels in einer neuen Indikation zu ermöglichen.

2 Hintergrund
Bei Zulassungsstudien handelt es sich in der Regel um Phase-III-Studien, die den Zulassungsbehörden ermöglichen, die Sicherheit und Wirksamkeit neuer Arzneimittel einzuschätzen. Sie genügen den Anforderungen der Good Clinical Practice und sind normalerweise randomisiert, kontrolliert und doppelblind.
https://flexikon.doccheck.com/de/Zulassungsstudie#:~:text=Ei...

Kim Metzger
Mexico
Native speaker of: Native in EnglishEnglish
PRO pts in category: 252

Peer comments on this reference comment (and responses from the reference poster)
agree  philgoddard
2 hrs
agree  Marga Shaw
8 hrs
agree  Johanna Timm, PhD
20 hrs
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