Re: Further blinding details:)

[Guest guest]

my vote for 2)

Hennie

-----Oorspronkelijk bericht-----

Van: Janos Fazakas

Aan: Medical_Translationegroups <Medical_Translationegroups>

Datum: vrijdag 18 februari 2000 11:51

Onderwerp: Further blinding details:)

>Dear Listmates,

>

>Thank you all for your comments. I have now read carefully through

>the whole text and I am now more puzzled than before.

>

>It just occured to me that I left out a most important aspect from

>my previous message.

>

>The title of the document is:

>

> " A Phase III, Investigator-Blinded, Multicenter, ... "

>

>Later on in the body of the document, it says:

>

> " Neither you nor your doctor will know which of the medications

>you receive ... "

>

>Well, I would comment as follows:

>

>1) The title implies that this is a single blind method, but of a rather

>curious nature in that it is the investigator who does not know what

>drug is being administered, while the patient knows. This would be

>quite uncommon as the investigator SHOULD be aware of the

>medication taken in order to be able to intervene if necessary.

>Anyway, if only one of the sides knows what is actually going on,

>then this is a SINGLE-BLIND METHOD

>

>2) The above is contradicted by the statement " Neither you nor

>your doctor will know ... " Well, by Jove this means DOUBLE-

>BLIND!!!

>

>Any comments?

>

>Thanks in advance.

>

>Regards,

>Janos

>============================================

>Janos Fazakas

>Transy Bt.

>GMP Audits & Validation in the Pharmaceutical Industry

>Charter Member of the Association of Hungarian Translation Companies

>Translations and Interpreting

>transy@...

>http://atril.com/bin/directory.dll/2286

>eFax: (413)895-0599 [for faxes sent from the USA]

>Mobile phone: +36-20-9844403

>

>------------------------------------------------------------------------

>If you took Podimin™, Redux®, or the combination " Fen-Phen, "

>visit the OFFICIAL site. Request the Court authorized notice package

>explaining your rights under the class settlement.

>http://click./1/833/2/_/98296/_/950871104/

>

>-- Talk to your group with your own voice!

>-- /VoiceChatPage?listName=medical_translation & m=1

>

>

[Guest guest]

Hi Janos!

I have some comments on your conclusions:

>1) The title implies that this is a single blind method, but of a rather

>curious nature in that it is the investigator who does not know what

>drug is being administered, while the patient knows. This would be

>quite uncommon as the investigator SHOULD be aware of the

>medication taken in order to be able to intervene if necessary.

>Anyway, if only one of the sides knows what is actually going on,

>then this is a SINGLE-BLIND METHOD

In a double-blind study, neither the patient, nor the investigator know the

treatment group the patient has been randomized to. This is so in all

double-blind studies although you believe that the investigator SHOULD be

aware of the medication assigned to intervene in case of emergency. Most

protocols set up procedures for breaking the blind should a serious adverse

reaction or any other problem occur. The vials in which the medicine is

dispensed usually have a two-part label including the patient's identity and

the drug the patient is taken. But nobody is allowed to know the identity

until the end of the study. One portion of the label remains attached to the

vial and the other portion is attached to the CRF.

>2) The above is contradicted by the statement " Neither you nor

>your doctor will know ... " Well, by Jove this means DOUBLE-

>BLIND!!!

Right, that is " double blind "

Greetings from Argentina

Silvia Gómez (Sil)

translaw@...

[Guest guest]

My vote is for 1). Let me explain : as I already said in my previous message

quoting the definition of blindness degrees, single blind (with blinded

investigator) is possible.

The problem here is that you may have 2 documents to translate (Please state

this point):

A) the first one : the protocol or a summary of the study

The Patient information sheet (and Informed consent sheet).

If you have 2 separate documents, there may be an error, i.e. the second

one, for the patient, has been pre-printed not only for this specific study,

or is not at all the one matching this specific study. In this case, you

should inform the client.

Normally, the title of a study must contain all the components of the Study

Design

So, have you 2 separate docs ?

Whatever is the answer, the client must be informed of this

" incompatibility "

GUILLIAUMET - France

Traductions Médicales - Médecine et Pharmacologie

Medical Translations - Medicine and Pharmacology

E-mail : cgtradmed@...

Phone : +33 (0)4 75 90 96 85

Fax : + 33 (0)4 75 90 96 91

-----Message d'origine-----

De : hennie duits

À : medical_translationegroups <medical_translationegroups>

Date : vendredi 18 février 2000 12:00

Objet : Re: Further blinding details:)

>my vote for 2)

>Hennie

>-----Oorspronkelijk bericht-----

>Van: Janos Fazakas

>Aan: Medical_Translationegroups <Medical_Translationegroups>

>Datum: vrijdag 18 februari 2000 11:51

>Onderwerp: Further blinding details:)

>

>

>>Dear Listmates,

>>

>>Thank you all for your comments. I have now read carefully through

>>the whole text and I am now more puzzled than before.

>>

>>It just occured to me that I left out a most important aspect from

>>my previous message.

>>

>>The title of the document is:

>>

>> " A Phase III, Investigator-Blinded, Multicenter, ... "

>>

>>Later on in the body of the document, it says:

>>

>> " Neither you nor your doctor will know which of the medications

>>you receive ... "

>>

>>Well, I would comment as follows:

>>

>>1) The title implies that this is a single blind method, but of a rather

>>curious nature in that it is the investigator who does not know what

>>drug is being administered, while the patient knows. This would be

>>quite uncommon as the investigator SHOULD be aware of the

>>medication taken in order to be able to intervene if necessary.

>>Anyway, if only one of the sides knows what is actually going on,

>>then this is a SINGLE-BLIND METHOD

>>

>>2) The above is contradicted by the statement " Neither you nor

>>your doctor will know ... " Well, by Jove this means DOUBLE-

>>BLIND!!!

>>

>>Any comments?

>>

>>Thanks in advance.

>>

>>Regards,

>>Janos

>>============================================

>>Janos Fazakas

>>Transy Bt.

>>GMP Audits & Validation in the Pharmaceutical Industry

>>Charter Member of the Association of Hungarian Translation Companies

>>Translations and Interpreting

>>transy@...

>>http://atril.com/bin/directory.dll/2286

>>eFax: (413)895-0599 [for faxes sent from the USA]

>>Mobile phone: +36-20-9844403

>>

>>------------------------------------------------------------------------

>>If you took Podimin™, Redux®, or the combination " Fen-Phen, "

>>visit the OFFICIAL site. Request the Court authorized notice package

>>explaining your rights under the class settlement.

>>http://click./1/833/2/_/98296/_/950871104/

>>

>>-- Talk to your group with your own voice!

>>-- /VoiceChatPage?listName=medical_translation & m=1

>>

>>

>

>

>

>------------------------------------------------------------------------

>You have a voice mail message waiting for you at iHello.com:

>http://click./1/1381/2/_/98296/_/950871411/

>

>-- Create a poll/survey for your group!

>-- /vote?listname=medical_translation & m=1

>

>

[Guest guest]

I must add to my previous message that, unfortunately, especially for

Patient Information Sheet, I've often seen them " built " using the " copy and

paste method " , the paragraphs pasted being taken from other similar

documents, and most of the time without checking if they really match the

context.

So, if the title clearly says, as it does, that it is a single blind study,

and that, somewhere else, it is suggested it is a double blind design, you

really should translate both as it is and inform yr client of the error.

This client will be grateful to you and your reputation will climb up :-)

GUILLIAUMET - France

Traductions Médicales - Médecine et Pharmacologie

Medical Translations - Medicine and Pharmacology

E-mail : cgtradmed@...

Phone : +33 (0)4 75 90 96 85

Fax : + 33 (0)4 75 90 96 91

-----Message d'origine-----

De : cgtradmed

À : medical_translationegroups <medical_translationegroups>

Date : vendredi 18 février 2000 12:17

Objet : Re: Further blinding details:)

>My vote is for 1). Let me explain : as I already said in my previous

message

>quoting the definition of blindness degrees, single blind (with blinded

>investigator) is possible.

>The problem here is that you may have 2 documents to translate (Please

state

>this point):

>A) the first one : the protocol or a summary of the study

> The Patient information sheet (and Informed consent sheet).

>If you have 2 separate documents, there may be an error, i.e. the second

>one, for the patient, has been pre-printed not only for this specific

study,

>or is not at all the one matching this specific study. In this case, you

>should inform the client.

>Normally, the title of a study must contain all the components of the Study

>Design

>So, have you 2 separate docs ?

>Whatever is the answer, the client must be informed of this

> " incompatibility "

> GUILLIAUMET - France

>Traductions Médicales - Médecine et Pharmacologie

>Medical Translations - Medicine and Pharmacology

>E-mail : cgtradmed@...

>Phone : +33 (0)4 75 90 96 85

>Fax : + 33 (0)4 75 90 96 91

>-----Message d'origine-----

>De : hennie duits

>À : medical_translationegroups <medical_translationegroups>

>Date : vendredi 18 février 2000 12:00

>Objet : Re: Further blinding details:)

>

>

>>my vote for 2)

>>Hennie

>>-----Oorspronkelijk bericht-----

>>Van: Janos Fazakas

>>Aan: Medical_Translationegroups <Medical_Translationegroups>

>>Datum: vrijdag 18 februari 2000 11:51

>>Onderwerp: Further blinding details:)

>>

>>

>>>Dear Listmates,

>>>

>>>Thank you all for your comments. I have now read carefully through

>>>the whole text and I am now more puzzled than before.

>>>

>>>It just occured to me that I left out a most important aspect from

>>>my previous message.

>>>

>>>The title of the document is:

>>>

>>> " A Phase III, Investigator-Blinded, Multicenter, ... "

>>>

>>>Later on in the body of the document, it says:

>>>

>>> " Neither you nor your doctor will know which of the medications

>>>you receive ... "

>>>

>>>Well, I would comment as follows:

>>>

>>>1) The title implies that this is a single blind method, but of a rather

>>>curious nature in that it is the investigator who does not know what

>>>drug is being administered, while the patient knows. This would be

>>>quite uncommon as the investigator SHOULD be aware of the

>>>medication taken in order to be able to intervene if necessary.

>>>Anyway, if only one of the sides knows what is actually going on,

>>>then this is a SINGLE-BLIND METHOD

>>>

>>>2) The above is contradicted by the statement " Neither you nor

>>>your doctor will know ... " Well, by Jove this means DOUBLE-

>>>BLIND!!!

>>>

>>>Any comments?

>>>

>>>Thanks in advance.

>>>

>>>Regards,

>>>Janos

>>>============================================

>>>Janos Fazakas

>>>Transy Bt.

>>>GMP Audits & Validation in the Pharmaceutical Industry

>>>Charter Member of the Association of Hungarian Translation Companies

>>>Translations and Interpreting

>>>transy@...

>>>http://atril.com/bin/directory.dll/2286

>>>eFax: (413)895-0599 [for faxes sent from the USA]

>>>Mobile phone: +36-20-9844403

>>>

>>>------------------------------------------------------------------------

>>>If you took Podimin™, Redux®, or the combination " Fen-Phen, "

>>>visit the OFFICIAL site. Request the Court authorized notice package

>>>explaining your rights under the class settlement.

>>>http://click./1/833/2/_/98296/_/950871104/

>>>

>>>-- Talk to your group with your own voice!

>>>-- /VoiceChatPage?listName=medical_translation & m=1

>>>

>>>

>>

>>

>>

>>------------------------------------------------------------------------

>>You have a voice mail message waiting for you at iHello.com:

>>http://click./1/1381/2/_/98296/_/950871411/

>>

>>-- Create a poll/survey for your group!

>>-- /vote?listname=medical_translation & m=1

>>

>>

>

>

>

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>

[Guest guest]

>>This would be

quite uncommon as the investigator SHOULD be aware of the

medication taken in order to be able to intervene if necessary.

<<

Not at all, the investigator should not be aware, but can usually

unblind the study for that patient if the situation (e.g. serious

complications) warrants it. Normally only a third party who is not

involved with the patient knows (e.g. someone in the pharmacy dispensing

the pills)

Hartelijke groeten * Bart *