Jan 29, 2013 02:36
11 yrs ago
7 viewers *
Spanish term

estudio pivote comparativo

Spanish to English Medical Medical: Pharmaceuticals
The phrase "pivote comparativo" is found in the letter from a pharmaceutical company to an ethics committee applying for approval to carry out its study:

"[drug name] comprende el estudio clínico pivote comparativo, farmacodinámico para establecer la bio-similaridad entre **** y ***** [drug names]. Un ensayo pivote adicional, comparativo, de seguridad y eficacia en una población de pacientes oncológicos también se llevará a cabo y se encuentra en etapa de planificación."

I found something about a PIVOT study (Prostate Cancer Intervention versus Observation Trial) but I'm not convinced that it has anything to do with this term. Anyone ever come across this term?
Votes to reclassify question as PRO/non-PRO:

Non-PRO (1): Neil Ashby

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Proposed translations

+5
4 mins
Selected

pivotal comparative study/trial

A "pivotal" trial is one that provides evidence (or tests a hypothesis) that is absolutely critical to further development or approval of a drug (or approval of an indication, etc.). You'll find plenty of references in the literature. A Google search should yield plenty of hits as well.
Peer comment(s):

agree Dr. Jason Faulkner : Beat me to it.
5 mins
Thank you, Dr. Faulkner!
agree philgoddard : "Usually a phase III study which presents the data that the FDA uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind."
1 hr
Thank you, Phil!
agree Emma Goldsmith : // Hope you enjoy the recording. It would've been a v. early start for you!
5 hrs
Thank you, Emma! Missed the webinar this morning, waiting for my link with bated breath :)
agree Neil Ashby : I agree, surely this would have been easier to find the translation than to post the question! Research, research, research!!!
5 hrs
Thank you, Dr Neil :) Well, "pivotal" is an unusual word... might not even cross the mind of someone not used to med/pharm jargon.
agree liz askew : How difficult was that to find!
7 hrs
You'd be surprised, actually. Not everyone is acquainted with clinical trial terminology!
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4 KudoZ points awarded for this answer. Comment: "Thanks so much!!"
7 mins

A comparative pivot study

I would think so...
Pivot studies are well known, and so are comparative studies.

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Note added at 9 mins (2013-01-29 02:45:04 GMT)
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http://www.healthnewsreview.org/2011/05/pivot-study-no-benef...
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+1
9 mins

pivotal comparative study

A pivotal study (phase 3) is the final study done for regulatory reasons before a drug is approved. It is also known as a "core" study. It is generally larger than the studies leading up to that point and is primarily carried out to confirm the findings of previous studies. It's generally the study presented in an application for drug approval.

SaludoZ!
Peer comment(s):

agree Filippe Vasconcellos de Freitas Guimarães : :)
25 mins
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