Re: HELP: Investigator-Blinded

[Guest guest]

At 09:52 AM 2/18/2000 +0100, you wrote:

>Dear Listmates,

>

>I am new to the group, and I already have a question to ask. The

>title of the Patient Information Sheet I am just now translating is:

>

> " A Phase III, Investigator-Blinded, Multicenter, Randomisad Study

>to Compare .... "

>

>I have heard of double-blind methods but I have never ever heard of

> " Investigator-Blinded " methods. I hope it does not mean that they

>blindfold the investigator:)

probably means that the investigator does not know who is in which group.

to be compared with a double blind study where no one knows (not the

investigator nor the subject) which group the patient is in, or a single

blind - where the investigator knows and the patient doesn't. but just

guessing...

fwiw

susan

translators' site du jour

http://home.ncia.com/~slarsson/sitejour.html

mailto:slarsson@...

swedish>english medical * business * technical

laconner, washington, usa * bokenäs, bohuslän, sverige

tel/fax +1 * cell phone +1

[Guest guest]

I think that in any good study the patient does not know what is being

administered.

And so, if the investigator 'also' doesn't know, I guess the result here is

a 'double blind study'?

Hennie

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

Van: Janos Fazakas

Aan: Medical_Translationegroups <Medical_Translationegroups>

Datum: vrijdag 18 februari 2000 9:54

Onderwerp: HELP: Investigator-Blinded

>Dear Listmates,

>

>I am new to the group, and I already have a question to ask. The

>title of the Patient Information Sheet I am just now translating is:

>

> " A Phase III, Investigator-Blinded, Multicenter, Randomisad Study

>to Compare .... "

>

>I have heard of double-blind methods but I have never ever heard of

> " Investigator-Blinded " methods. I hope it does not mean that they

>blindfold the investigator:)

>

>I would be grateful for any hints.

>

>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/_/950864060/

>

>-- 20 megs of disk space in your group's Document Vault

>-- /docvault/medical_translation/?m=1

>

>

>

[Guest guest]

Hi, Janos

This is another way of saying " single blind " . I don't know if you understand

French, because to be as precise as the English original, we would say

" a(with accent) l'insu de l'investigateur " , while it is normally said " en

simple insu " which is the exact equivalent of " single blind " .

Hope it helps

Have a nice day

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 : Janos Fazakas

À : Medical_Translationegroups <Medical_Translationegroups>

Date : vendredi 18 février 2000 09:57

Objet : HELP: Investigator-Blinded

>Dear Listmates,

>

>I am new to the group, and I already have a question to ask. The

>title of the Patient Information Sheet I am just now translating is:

>

> " A Phase III, Investigator-Blinded, Multicenter, Randomisad Study

>to Compare .... "

>

>I have heard of double-blind methods but I have never ever heard of

> " Investigator-Blinded " methods. I hope it does not mean that they

>blindfold the investigator:)

>

>I would be grateful for any hints.

>

>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/_/950864060/

>

>-- 20 megs of disk space in your group's Document Vault

>-- /docvault/medical_translation/?m=1

>

>

[Guest guest]

Hi Hennie,

Very interesting point, indeed. But, as yous say " in any good study " . In

fact, it could be " double blind " except in certain cases, it happens the

investigator is the only one who doesn't know.

Definition of the different degrees of blindness, source : de

l'Investigateur (Investigator's Manual) by Dr; Maxime DOUGADOS, ed :

CIBA-GEIGY :

" Single blind = one of the parties (either the patient, or MORE FREQUENTLY,

the investigator) knows the nature of the administered treatment

Double blind = Both investigator and patient don't know what is the

treatment administered.

Triple blind = Not only both investigator and patient don't know anything

about the treatment, but also a third party, generally the one responsible

for the study mangement. "

Technically speaking, in single blind (I mean when well conducted) the

investigator is not the physician who actually treats the patient, he is the

one who only has to check the effects and results.

Hope it is clearer for everybody.

Cheers

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 10:31

Objet : Re: HELP: Investigator-Blinded

>I think that in any good study the patient does not know what is being

>administered.

>And so, if the investigator 'also' doesn't know, I guess the result here is

>a 'double blind study'?

>Hennie

>

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

>Van: Janos Fazakas

>Aan: Medical_Translationegroups <Medical_Translationegroups>

>Datum: vrijdag 18 februari 2000 9:54

>Onderwerp: HELP: Investigator-Blinded

>

>

>>Dear Listmates,

>>

>>I am new to the group, and I already have a question to ask. The

>>title of the Patient Information Sheet I am just now translating is:

>>

>> " A Phase III, Investigator-Blinded, Multicenter, Randomisad Study

>>to Compare .... "

>>

>>I have heard of double-blind methods but I have never ever heard of

>> " Investigator-Blinded " methods. I hope it does not mean that they

>>blindfold the investigator:)

>>

>>I would be grateful for any hints.

>>

>>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/_/950864060/

>>

>>-- 20 megs of disk space in your group's Document Vault

>>-- /docvault/medical_translation/?m=1

>>

>>

>>

>

>

>

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

>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/_/950866094/

>

>eGroups.com Home: /group/medical_translation/

> - Simplifying group communications

>

>

[Guest guest]

In a message dated 2/18/00 1:29:48 AM Pacific Standard Time, he.duits@...

writes:

<< if the investigator 'also' doesn't know, I guess the result here is

a 'double blind study'? >>

" double blind " yes but not " blinded " - it is simply an error of the

writer's (rather common in fact) to make a past participle of the noun which

is used as a modifier of another noun, it does not change the meaning of the

term - ah English, that devil language!

Vera

[Guest guest]

>>I think that in any good study the patient does not know what is being

administered.

And so, if the investigator 'also' doesn't know, I guess the result here

is

a 'double blind study'?

<<

It is not always possible to have the patient and the investigator both

blind to the treatment - if you compare an operation with pills, for

instance, the patient will inevitably know in which group he is, or if

the medicine being tested has clear side-effects.

In such cases you will have to do the best you can, ie let an unbiased

(blinded) observer record the results.

Hartelijke groeten * Bart *