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Phase III trials

English translation: Phase III trials


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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Phase III trials
English translation:Phase III trials
Entered by: Fathy Shehatto
Options:
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20:56 Jun 19, 2009
English to English translations [PRO]
Medical - Medical: Pharmaceuticals / Trial
English term or phrase: Phase III trials
(Study's Name) which will end in (Date) is part of an entire program to bring (Drug's name) to the patients who need it. This program includes 2 other *** Phase III trials *** that have been conducted in parallel to (Study's Name). After the trials are completed, all the data needs to be analyzed and presented to the various health authorities in the world for approval. This takes a lot of time: we anticipate that telaprevir will be commercially available 2 years after ending the trials. It is expected that other new therapies will start to be available in the years that follow.


To me it seems that, "Phase III" is an adjective for trials.

Translator's suggestion is: "this program includes 2 other trials, each one consists of 3 phases".

Proofreader's suggestion is: "this program includes 2 other trials, both are in the third phase (Phase 3 )"

Your suggestions are appreciated.


This link may help


TIA
Fathy Shehatto
Local time: 04:03
Phase III trials
Explanation:
Phase III is very specific in this context. It must be left this way.

Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.

http://en.wikipedia.org/wiki/Clinical_trial#Phase_III

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Note added at 4 mins (2009-06-19 21:01:41 GMT)
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From the United States NIH (National Institutes of Health) website:

CLINICAL TRIAL: A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed.

http://www.clinicaltrials.gov/ct2/info/glossary
Selected response from:

Richard McDorman
United States
Local time: 22:03
Grading comment
Thank you Richard
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +11Phase III trials
Richard McDorman
3 -33 phase
Gary D
Summary of reference entries provided
Phase III studies
Veronica Prpic Uhing

Discussion entries: 4





  

Answers


3 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +11
*** phase iii trials ***
Phase III trials


Explanation:
Phase III is very specific in this context. It must be left this way.

Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.

http://en.wikipedia.org/wiki/Clinical_trial#Phase_III

--------------------------------------------------
Note added at 4 mins (2009-06-19 21:01:41 GMT)
--------------------------------------------------

From the United States NIH (National Institutes of Health) website:

CLINICAL TRIAL: A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed.

http://www.clinicaltrials.gov/ct2/info/glossary

Richard McDorman
United States
Local time: 22:03
Native speaker of: Native in EnglishEnglish
PRO pts in category: 4
Grading comment
Thank you Richard
Notes to answerer
Asker: Thank you very much, Richard


Peer comments on this answer (and responses from the answerer)
agree  Michael Powers (PhD): nice explanation, Richard - Mike :) Still, you took the time to look it up and post it. You still deserve credit.
0 min
  -> Thanks, Mike (I took the description from Wikipedia, though).
agree  Enza Longo: yes, the original is perfectly correct
8 mins
  -> Thanks.
agree  Marina Menendez
1 hr
  -> Gracias, Marina.
agree  Irina Bacioiu
2 hrs
  -> Thanks, Irina.
agree  Siegfried Armbruster
6 hrs
  -> Thank you.
agree  chaman4723: A very perfect explanation
6 hrs
  -> Thanks very much. I appreciate that :)
agree  sibsab
7 hrs
  -> Thanks.
agree  Phong Le
10 hrs
  -> Thank you.
agree  Helen Genevier
13 hrs
  -> Thanks, Helen :)
agree  lirka: definitely
17 hrs
  -> Thank you.
agree  Elena Aleksandrova
18 hrs
  -> Gracias, Elena! :)
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1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): -3
*** phase iii trials ***
3 phase


Explanation:
I am leaning the other way as the pretext says:

" is part of an entire program to bring"

An emphasis on "ENTIRE"

If you were in Phase III of a trial it would NOT be called the ENTIRE program, but Phase III of the program with 2 other Phase III trials running in parallel

This program (This Entire Program) includes 2 other 3 Phase trials that have been conducted in parallel to.

This is how I read it..


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Note added at 1 hr (2009-06-19 22:25:50 GMT)
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Ie; They are not going to have 2, 4 Phase trials.

If the entire program went into the 3rd phase there would not be 2, 3rd phases of the Entire trial but 2 segments of the 3rd phase or a 3rd phase and then a 4th phase.

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Note added at 13 hrs (2009-06-20 10:54:12 GMT)
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You could not have an entire program which ran a single phase 1 and phase II and then ran 2 phase III trials in parallel, because both of the parallel Phase III trials would have had to have a Phase 1 and a Phase II.

The link provided by Fathy Shehatto clearly states this.

If you test 10 people in phase 1 and 30 people in Phase II. How do you obtain the correct numbers for running 2 phase III trials in parallel and still end up with a clinical outcome? One of the parallel phase III trials would have no previous data.

Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed.

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Note added at 14 hrs (2009-06-20 11:02:21 GMT)
--------------------------------------------------

If you started with 1 phase1 trial, by the time you go to phase III it wouldn't matter if you did split it in to two, as it is apart of the same trial, it cannot be a separate Phase as it is still a part of the initial trial. Phase III of a trial is still a single Phase III no matter how many modules it is split into.
If you undertake a separate clinical test in a trial, then it would have to be called a new trial or Phase 1 of the new trial.
Fathy Shehattos' proofreaders determination that "this program includes 2 other trials, both are in the third phase (Phase 3 " is correct.

Gary D
Local time: 12:03
Native speaker of: Native in EnglishEnglish
PRO pts in category: 7

Peer comments on this answer (and responses from the answerer)
disagree  Helen Genevier: Readers who know the basics of drug trials would find no ambiguity here - Phase III trials (captalised, III not 3) can only mean one thing as explained by Richard/They could be conducted in early or late-stage disease, young or old patients etc.
12 hrs
  -> Assuming it is translated correctly, looking at the link provided there is no provision for 2 parallel Phase III trials
disagree  Siegfried Armbruster: fully agree with Helen, and there is no need to start a discussion if 2 or more parallel Phase III trials are possible or not, this is also basic knowledge // keep on reading you are nearly there
12 hrs
  -> Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment
disagree  lirka: everything has already been stated above
15 hrs
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Reference comments


2 hrs
Reference: Phase III studies

Reference information:
Since you mentioned telaprevir -

Here you can find the names of 2 other Phase III trials with enrolment closed, so there is one more


    Reference: http://www.news-medical.net/news/20090605/HCV-protease-inhib...
    Reference: http://www.vpharm.com/current-projects/drug-candidates/telap...
Veronica Prpic Uhing
United States
Specializes in field
Native speaker of: Croatian
PRO pts in category: 20
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Voters for reclassification
as
PRO / non-PRO		Non-PRO (1): Siegfried Armbruster


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Changes made by editors
Jun 20, 2009 - Changes made by Steffen Walter:
Term asked*** Phase III trials *** => Phase III trials


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