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a phase 3/4

English translation: phases 3-4 (phase 3 and phase 4)

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:a phase 3/4
Selected answer:phases 3-4 (phase 3 and phase 4)
Entered by: Charles Davis

10:09 Aug 11, 2012
English language (monolingual) [PRO]
Medical - Medical: Pharmaceuticals / Clinical trial
English term or phrase: a phase 3/4
This study is a Phase 3/4, multicenter, randomized, double-blind, placebo-controlled study to be conducted in approximately 500 sites globally.

- What does the separator "/" refer to in the above context?
- Does it mean phase 3 of a study which is consisted of 4 phases? i.e. phase 3 out of 4?

TIA
Fathy Shehatto
Egypt
Local time: 23:03
phases 3-4 (phase 3 and phase 4)
Explanation:
As Peter has said, the oblique barre, which is properly used to indicate alternatives, is very commonly used to indicate "as well as", or a span or continuation. This is the case here.

The four phases of clinical trials (or five according to more recent definitions) are well defined. Phase 3 is "testing of drug for intended use as therapy", and Phase 4 is "postmarketing surveillance - watching drug use in public".
http://en.wikipedia.org/wiki/Phases_of_clinical_research
There is no actual intermediate phase (though the second part of Phase 3 is often called 3b (or IIIb). However, there are trials which extend over more than one phase, and this is the case here:

"Clinical trials are classified by phase most commonly for drugs, biologics, and devices in the FDA approval process for marketing (although the trials themselves may extend beyond the date of approval). NIH also describes trials by phase, for example, trials in cancer and AIDS, which are listed in their respective registries by phase. Clear lines do not necessarily demarcate one phase from another, however, and trials may be denoted as "phase 1/2" or "phase 3/4.""
http://www.nap.edu/openbook.php?record_id=9742&page=69

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Note added at 10 hrs (2012-08-11 20:28:22 GMT)
--------------------------------------------------

This does not mean Phase 3 out of 4. There would be no point in adding "/4" for "out of 4" if it referred only to Phase 3, because everyone involved in clinical trials knows that there are four phases. And clearly "Phase 1/2" doesn't mean 1 out of 2, because there are never just two phases; it means phases 1 and 2. "Phase 3/4" definitely means trials corresponding to Phases 3 and 4. It is common usage in that sense:

" If the Phase 2 trials show that the drug possibly works, then the Phase 3/4 trials begin. Phase 3/4 trials are VERY large trials conducted over a VERY long period of time. In fact, many times the Phase 3/4 trials will happen even after a drug has been marketed to the public already. (There are still some Viagara Phase 3 and Phase 4 trials taking place). In these trials the goal is to see if there are any long-term side effects of taking the drug. Sample sizes in excess of 1,000+ patients are no uncommon and the trial lengths can exceed 10 years. "
http://www.retrojunk.com/forum/post/list/7542/2

It is also sometimes written as "Phase 3,4" or "Phase 3-4":

"Interventional clinical trials, usually drug trials, are categorised into different phases. A phase 1 trial is an initial study to determine side effects and the maximum tolerated dose. A phase 2 trial includes trials that test the effectiveness of a drug as well as side effects. Phase 3 trials are usually randomised and test the new treatment against the standard treatment. Phase 4 trials are post-marketing studies to monitor side effects, benefits and optimal use of an intervention in the wider population. A category “not applicable” is available for non-drug trials. Phase is not compulsory for registrants on the ANZCTR so “not recorded” was entered for trials with blanks. For the CT.gov trials, phase is a compulsory data item. For trials classified as Phase 1/2 these were recoded as Phase 2, Phase 2/3 trials were recoded as Phase 3 trials One ANZCTR trial registered as Phase 3/4 trials was recoded as a Phase 4 trial as this best fit the study design. "
http://www.psych.usyd.edu.au/cemped/docs/Appendix_revised.pd...


"Phase 3/4 clinical trial data is, by far, the best quality, albeit with much lower sample size. [...] Prospective, randomized, double-blind clinical trials (Phase 3 and 4) provide by far the best quality data for assessment of drug effects on adverse events."
http://www.dddmag.com/articles/2008/04/digging-data
"Where relevant, has adequate justification been provided for
hybrid study design (e.g. Phase 1/2 or Phase 3/4 studies)?"
http://www.fpnsw.org.au/scientific_advisory_group_tor_final....

--------------------------------------------------
Note added at 23 hrs (2012-08-12 09:20:28 GMT)
--------------------------------------------------

It is not true that a clinical trial is necessarily confined to a single phase. On the contrary, trials frequently correspond to more than one phase:

"Four phases of clinical trials and medicine development exist and are defined below. Each of these definitions is a functional one and the terms are not defined on a strict chronological basis. An investigational medicine is often evaluated in two or more phases simultaneously in different clinical trials. Also, some clinical trials may overlap two different phases."
http://www.virginia.edu/vpr/irb/HSR_docs/CLINICAL_TRIALS_Pha...

That is what "Phase 1/2" or "Phase 3/4" means, or indeed "Phase 3-4":

"Sulodexide Gelcaps : An Oral Heparinoid for the Treatment of Diabetic Nephropathy Gets Ready for Phase 3-4 Trial [...]
Keryx Biopharmaceuticals, Inc. announced today that it has finalized a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration (FDA) for the Phase 3 and Phase 4 clinical trials of KRX-101 (sulodexide gelcaps), the Company's drug candidate for the treatment of diabetic nephropathy."
http://www.rxpgnews.com/nephrology/Sulodexide_Gelcaps_An_Ora...
Selected response from:

Charles Davis
Spain
Local time: 22:03
Grading comment
4 KudoZ points were awarded for this answer



SUMMARY OF ALL EXPLANATIONS PROVIDED
4 +1a phase 3 study or clinical trial out of 4 phases
Marga Shaw
4 +1phases 3-4 (phase 3 and phase 4)
Charles Davis
4Either Phase 3 AND Phase 4, or an intermediate phase
Peter Skipp


  

Answers


6 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
Either Phase 3 AND Phase 4, or an intermediate phase


Explanation:
Without more context, it is impossible to be certain. The oblique sign (the "/") used to indicate the phrase "either/or", but is now used more and more to indicate the phrase "as well as".

So:

- either a study which involves both Stage 3 and Stage 4

- or a study which centres on an intermediate stage between Stage 3 and Stage 4 ("Stage 3.5", so to speak).

In now way do I think it likely that only Phase 3 is involved.

--------------------------------------------------
Note added at 7 mins (2012-08-11 10:16:54 GMT)
--------------------------------------------------

Eratum last sentence: meant to write "In no way..."

--------------------------------------------------
Note added at 15 mins (2012-08-11 10:24:56 GMT)
--------------------------------------------------

For some ideas and conventions on the oblique/stroke/forward slash sign ("/"), see:

http://en.wikipedia.org/wiki/Slash_(punctuation)

http://www.englishclub.com/writing/punctuation-slash.htm

http://dictionary.reference.com/browse/oblique stroke

http://oxforddictionaries.com/definition/american_english/sl...

Peter Skipp
Bulgaria
Local time: 23:03
Native speaker of: Native in BulgarianBulgarian, Native in EnglishEnglish
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
a phase 3 study or clinical trial out of 4 phases


Explanation:
"This study is a phase 3 [out of 4 phases] multicenter, randomized ... study ..."

As I understand it - only phase 3 out of the four phases of a study or clinical trial is conducted.

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases 1, 2, and 3, it will usually be approved by the national regulatory authority for use in the general population.

Phase 1: Screening for safety
Phase 2: Establishing the testing protocol
Phase 3: Final testing
Phase 4: Postapproval studies
http://en.wikipedia.org/wiki/Clinical_trial

Phase 1, 2 , 3 and 4 trials

This page is about the different phases of clinical trials. It has information about

Phase 1 trials
Phase 2 trials
Phase 3 trials
Randomisation
Overview studies
Phase 4 trials
http://cancerhelp.cancerresearchuk.org/trials/types-of-trial...

http://clinicaltrials.gov/ct2/info/glossary#placeboc





Marga Shaw
United Kingdom
Local time: 21:03
Specializes in field
Native speaker of: German
PRO pts in category: 8

Peer comments on this answer (and responses from the answerer)
agree  Tina Vonhof (X): For obvious reasons, phase 3 and 4 cannot be done at the same time. Phase 4 cannot begin until phased 3 has been completed and the drug has been approved.
3 hrs
  -> Absolutely. Thank you Tina.
neutral  Charles Davis: According to this argument, "Phase 1/2" would mean "Phase 1 out of 2", but that would be nonsense / No; trials frequently include more than one phase, and the demarcation between phases is often not clear-cut in any case.
8 hrs
  -> In a clinical trial you complete each phase, i.e. phases 1 to 4, individually, not together. The conduct of each phase is dependent on the outcome & evaluation of the previous phase; with the recruitment of new subjects & a new protocol for each phase.
Login to enter a peer comment (or grade)

19 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
phases 3-4 (phase 3 and phase 4)


Explanation:
As Peter has said, the oblique barre, which is properly used to indicate alternatives, is very commonly used to indicate "as well as", or a span or continuation. This is the case here.

The four phases of clinical trials (or five according to more recent definitions) are well defined. Phase 3 is "testing of drug for intended use as therapy", and Phase 4 is "postmarketing surveillance - watching drug use in public".
http://en.wikipedia.org/wiki/Phases_of_clinical_research
There is no actual intermediate phase (though the second part of Phase 3 is often called 3b (or IIIb). However, there are trials which extend over more than one phase, and this is the case here:

"Clinical trials are classified by phase most commonly for drugs, biologics, and devices in the FDA approval process for marketing (although the trials themselves may extend beyond the date of approval). NIH also describes trials by phase, for example, trials in cancer and AIDS, which are listed in their respective registries by phase. Clear lines do not necessarily demarcate one phase from another, however, and trials may be denoted as "phase 1/2" or "phase 3/4.""
http://www.nap.edu/openbook.php?record_id=9742&page=69

--------------------------------------------------
Note added at 10 hrs (2012-08-11 20:28:22 GMT)
--------------------------------------------------

This does not mean Phase 3 out of 4. There would be no point in adding "/4" for "out of 4" if it referred only to Phase 3, because everyone involved in clinical trials knows that there are four phases. And clearly "Phase 1/2" doesn't mean 1 out of 2, because there are never just two phases; it means phases 1 and 2. "Phase 3/4" definitely means trials corresponding to Phases 3 and 4. It is common usage in that sense:

" If the Phase 2 trials show that the drug possibly works, then the Phase 3/4 trials begin. Phase 3/4 trials are VERY large trials conducted over a VERY long period of time. In fact, many times the Phase 3/4 trials will happen even after a drug has been marketed to the public already. (There are still some Viagara Phase 3 and Phase 4 trials taking place). In these trials the goal is to see if there are any long-term side effects of taking the drug. Sample sizes in excess of 1,000+ patients are no uncommon and the trial lengths can exceed 10 years. "
http://www.retrojunk.com/forum/post/list/7542/2

It is also sometimes written as "Phase 3,4" or "Phase 3-4":

"Interventional clinical trials, usually drug trials, are categorised into different phases. A phase 1 trial is an initial study to determine side effects and the maximum tolerated dose. A phase 2 trial includes trials that test the effectiveness of a drug as well as side effects. Phase 3 trials are usually randomised and test the new treatment against the standard treatment. Phase 4 trials are post-marketing studies to monitor side effects, benefits and optimal use of an intervention in the wider population. A category “not applicable” is available for non-drug trials. Phase is not compulsory for registrants on the ANZCTR so “not recorded” was entered for trials with blanks. For the CT.gov trials, phase is a compulsory data item. For trials classified as Phase 1/2 these were recoded as Phase 2, Phase 2/3 trials were recoded as Phase 3 trials One ANZCTR trial registered as Phase 3/4 trials was recoded as a Phase 4 trial as this best fit the study design. "
http://www.psych.usyd.edu.au/cemped/docs/Appendix_revised.pd...


"Phase 3/4 clinical trial data is, by far, the best quality, albeit with much lower sample size. [...] Prospective, randomized, double-blind clinical trials (Phase 3 and 4) provide by far the best quality data for assessment of drug effects on adverse events."
http://www.dddmag.com/articles/2008/04/digging-data
"Where relevant, has adequate justification been provided for
hybrid study design (e.g. Phase 1/2 or Phase 3/4 studies)?"
http://www.fpnsw.org.au/scientific_advisory_group_tor_final....

--------------------------------------------------
Note added at 23 hrs (2012-08-12 09:20:28 GMT)
--------------------------------------------------

It is not true that a clinical trial is necessarily confined to a single phase. On the contrary, trials frequently correspond to more than one phase:

"Four phases of clinical trials and medicine development exist and are defined below. Each of these definitions is a functional one and the terms are not defined on a strict chronological basis. An investigational medicine is often evaluated in two or more phases simultaneously in different clinical trials. Also, some clinical trials may overlap two different phases."
http://www.virginia.edu/vpr/irb/HSR_docs/CLINICAL_TRIALS_Pha...

That is what "Phase 1/2" or "Phase 3/4" means, or indeed "Phase 3-4":

"Sulodexide Gelcaps : An Oral Heparinoid for the Treatment of Diabetic Nephropathy Gets Ready for Phase 3-4 Trial [...]
Keryx Biopharmaceuticals, Inc. announced today that it has finalized a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration (FDA) for the Phase 3 and Phase 4 clinical trials of KRX-101 (sulodexide gelcaps), the Company's drug candidate for the treatment of diabetic nephropathy."
http://www.rxpgnews.com/nephrology/Sulodexide_Gelcaps_An_Ora...


Charles Davis
Spain
Local time: 22:03
Native speaker of: English
PRO pts in category: 24

Peer comments on this answer (and responses from the answerer)
agree  Harald Moelzer (medical-translator): definitely
2 days 10 hrs
  -> Thank you, Harald!
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