KudoZ home » English » Medical: Pharmaceuticals

pivotal study

Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs
(or are passionate about them). Participation is free and the site has a strict confidentiality policy.

13:25 Nov 29, 2011

This question was closed without grading. Reason: No acceptable answer

English to English translations [PRO]
Medical - Medical: Pharmaceuticals

English term or phrase: pivotal study

What is a pivotal study? More importantly, what is so "pivotal" about it? Does "pivot" refer to importance or to a statistical (mathematical) turning point? If the word "pivot" didn't exist in English, what would such a study be called?

Samuel Murray KudoZ activity Questions: 17 (none open) (3 without valid answers) (2 closed without grading) Answers: 169 Netherlands
Local time: 04:04

Summary of answers provided

4 +7

a final, decisive study in a series of clinical trials

Charles Davis

4 +4

a study that meets the criteria noted below

Jenni Lukac

a study which is a turning point

kamilw

Summary of reference entries provided

pivotal

Stephanie Ezrol

More FDA documents

Alison MacG

Answers

5 mins confidence:

a study which is a turning point

Explanation:
Literally, a turning point. Or a milestone, breakthrough etc. The etymology of "pivotal" has got something to do with turning, but I'm not exactly sure what.

kamilw
Local time: 04:04
Specializes in field
Native speaker of:

Polish

17 mins confidence:

peer agreement (net): +7

a final, decisive study in a series of clinical trials

Explanation:
In everyday language, "pivotal" really means "decisive": an important decision turns on the results: "of crucial importance in relation to the development or success of something else", as defined in the Oxford Dictionary online.

However, the heading of the question, "Pharmaceuticals", suggests that a more technical meaning of the term is involved here, related to the testing procedures of the FDA in the United States. It is defined as follows in the Clinical Trials Glossary of the Centerwatch website:

"Pivotal Study
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."

A Phase III study means:
"The third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling."
http://www.centerwatch.com/health-resources/glossary/#Glossa...

--------------------------------------------------
Note added at 19 mins (2011-11-29 13:45:39 GMT)
--------------------------------------------------

I have said "final", though the pivotal study will not necessarily be the last of all those conducted. It is, however, decisive: the FDA bases its decision on the outcome of this study.

Charles Davis
Local time: 04:04
Native speaker of:

English

Peer comments on this answer (and responses from the answerer)

agree

Tina Vonhof

2 hrs

-> Thanks, Tina :)

agree

Stephanie Ezrol

2 hrs

-> Thanks, Stephanie :)

agree

Clauwolf

2 hrs

-> Thanks, Clauwolf :)

agree

fvasconcellos: I agree. If the word "pivot" did not exist in English (what an interesting mental exercise!), these studies would probably be called "decisive" or "crucial"... although I can't think of any word that would equal the marketing impact of "pivotal" :)

3 hrs

-> Yes, it does make it sound positively epoch-making, doesn't it? Thanks :)

agree

Ildiko Santana

8 hrs

-> Thanks, Ildiko :)

agree

Jenni Lukac: Cheers and thanks, Ildiko.

19 hrs

-> Hi Jenni. Thanks a lot, but did you mean to put this here?

agree

Alison MacG

20 hrs

-> Many thanks, Alison :)

11 mins confidence:

peer agreement (net): +4

a study that meets the criteria noted below

Explanation:
To be considered pivotal, a study must meet
at least the following 4 FDA-defined criteria: © Adis Data Information BV 2006
Phase III (cont.)
Be controlled using placebo or a standard therapy.
Have a double-blinded design when such a design is practical and ethical. Be
randomized.
Be of adequate size. Study sample size is a common clinical trial design flaw.
http://www.adisinsight.com/aClientServiceinfo/RDI Phases of ...

--------------------------------------------------
Note added at 1 hr (2011-11-29 15:04:07 GMT)
--------------------------------------------------

I don't know if this information will help you, but here are some references: Pivotal Clinical Trials : Those clinical studies that provide the significant evidence that is the basis for the decision as to the risk-benefit assessment for a particular FDC.
Read more: http://wiki.answers.com/Q/What_is_a_pivotal_clinical_trial#i... The primary purpose of Pivotal studies directed at obtaining the FDA’s approval to market an unapproved device as a 510(k) device is to validate that the product performs in an equivalent manner to another legally marketed (i.e., predicate) device. Substantial equivalence between the devices may be demonstrated through side-by-side comparisons of the device or pilot studies with the unapproved device alone. in: www.o3is.pitt.edu/.../ContentandFormatofIDEAp.; Pilot Study
A pilot trial is used to obtain information, and work out the logistics and management, deemed necessary for further clinical trials. Although pilot trials are often unblind and use open-label medicines, they may also be single or double blind and may include tight control on all appropriate variables. The term “pilot” refers to the purpose of the trial (2).
Pivotal Study
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. http://www.centerwatch.com/health-resources/glossary/#Glossa...
In this context, the results of the pivotal studies will determine whether a device, procedure, or drug will be approved (the FDA is the US government Food and Drug Administration. In other countries it would be another entity that would have the power to approve, NHS in the case of Great Britain: www.nice.org.uk/guidance/index.jsp?action... -
30 Mar 2010 – ... and will publish guidance on its safety and efficacy to the NHS in England, Wales, ... Research outcomes should include depression rating scales, ... that of 59 patients in the 'pilot' and 205 patients in the 'pivotal' study, 61% ...

Jenni Lukac
Local time: 04:04
Native speaker of:

English

Notes to answerer

Asker: Yes, but what is it about that criteria that make it "pivotal"? Or do you mean to tell me that "pivotal" has no actual meaning and that it is just a random word chosen by the pharmaceutical industry to denote this specific type of study?

Reference comments

2 hrs

Reference: pivotal

Reference information:
"being that on which something turns or hinges, central, cardinal. 1844, formed from English pivot."

pivot:
'the figuative sense of that on which something turns or hinges, cardinal or central point is first recorded in English in 1813."

Chambers Dictionary of Etymology
1988 copyright

Stephanie Ezrol
United States
Native speaker of:

English

21 hrs

Reference: More FDA documents

Reference information:
The slightly more detailed information found here may also be useful.

Staged approval is most common for pivotal studies (i.e., studies that are designed to provide the primary clinical evidence to support a marketing application)
http://mdtmag.com/News/Feeds/2011/11/sections-regulatory-new...

Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff - Design Considerations for Pivotal Clinical Investigations for Medical Devices
This guidance describes principles that should be followed for the design of premarket clinical studies that are pivotal in establishing the safety and effectiveness of a medical device.
Glossary
Pivotal Stage
Clinical development stage for medical devices during which the evidence is gathered to support the evaluation of the safety and effectiveness of the medical device. The stage consists of one or more pivotal studies.
Pivotal Study
A definitive study during which evidence is gathered to support the safety and effectiveness evaluation of the medical device for its intended use.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...

FDA: Evidentiary Standards for Drug Development and Approval
Typically, the Agency requires that, for definitive effectiveness trials, protocols prospectively specify a single primary outcome, i.e., a single outcome is designated as the outcome on which the primary between-treatment contrast is performed, and the results of this analysis serve as the basis for concluding that the study can contribute to a finding of substantial evidence of effectiveness (a so-called “pivotal” study).
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534930/

Alison MacG
United Kingdom
Native speaker of:

English
PRO pts in category: 4

Return to KudoZ list

KudoZ™ translation help
The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.

Overview

Latest translation questions

Ask a translation question

See also:

ProZ.com term search

Search millions of term translations

pivotal study

Login or register (free and only takes a few minutes) to participate in this question.

Answers

Reference comments

Sign in to your ProZ.com account...

Or create a new account

ProZ.com ideas

KudoZ™ translation help
The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.

pivotal study

Login or register (free and only takes a few minutes) to participate in this question.

Answers

Reference comments

Sign in to your ProZ.com account...

Or create a new account

ProZ.com ideas

KudoZ™ translation helpThe KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.

KudoZ™ translation help
The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.