Re: TERM EN > FR competitive enrollment (clinical trial)

[Guest guest]

Marie,

" Competitive enrolment " means that the sponsor contacted several groups of

researchers which are in charge of recruiting a certain number of patients. The

faster they reach their target (number of patients) the higher is the

probability they will be the " elected research group " . In other words the first

research team to provide a large enough number of patients hits the jack pot and

get the money for the trial. There is a competition for enroling patients.

This is intended to decrease the cost of recruiting patient for clinical trials

(1.8 B$ per year)

See : http://www.law.ualberta.ca/centres/hli/pdfs/hlr/v13_2 & 3/07_Caulfield.pdf

Hope this helps,

Philippe

TERM EN > FR competitive enrollment (clinical trial)

Dear all,

I am translating a information and consent form for a clinical trial. In the

paragraph " Can I be removed from the study without my permission? " it says:

...or for administrative reasons, including competitive enrollment - the

target number of subjects has entered the treatment phase. "

I never came across " competitive enrollment " . Have you? If so, what is the

translation in French? Does it simply mean that the sponsor has enough patients

in the treatment phase and that there are no more space for other?

PS: the study comprises an open phase when the subjects receive the actual

treatment.

Many thanks,

Marie

Marie Désy-Field, cert. tr. OTTIAQ,

MITI, MCIL

Translation and voice-over

DésyField Ltd

Tel.: +44 (0) 20 8748 3436

Fax: +44 (0) 20 8741 4543

Mobile : 07747 637229

e-mail: marie@... (or marie@...)

www.desyfield.co.uk

[Guest guest]

Originally parked in the " spam " section of Yahoo, and visible on the site only

today Sept. 08. This is an automated, stupid and apparently random process which

is out of the Moderator's control.

Really sorry, while absolutely innocent :-)

The Moderator

Me again.

You need to differentiate " competitive " and " balanced " enrollment.

Should you need N patients for your trial, using 10 research centers, balanced

enrollment means that each center will enroll until it reaches its own assigned

n = N/10 patients. Competitive enrollment means that all centers will enroll

(competition) until the total N is fulfilled; the number of patients not being

mandatorily even between different centers. Which - in some cases - may result

in the selection of a single research center (competition again).

AW: TERM EN > FR competitive enrollment (clinical trial)

I guess it means that the patient has been enrolled in another clinical

trial, too. This is usually not allowed.

Regards

Charlotte

-----Ursprüngliche Nachricht-----

Von: medical_translation

[mailto:medical_translation ]Im Auftrag von Marie Desy-Field

Gesendet: Donnerstag, 23. August 2007 11:25

An: Medical translation group

Betreff: TERM EN > FR competitive enrollment (clinical trial)

Dear all,

I am translating a information and consent form for a clinical trial. In

the paragraph " Can I be removed from the study without my permission? " it

says:

...or for administrative reasons, including competitive enrollment - the

target number of subjects has entered the treatment phase. "

I never came across " competitive enrollment " . Have you? If so, what is the

translation in French? Does it simply mean that the sponsor has enough

patients in the treatment phase and that there are no more space for other?

PS: the study comprises an open phase when the subjects receive the actual

treatment.

Many thanks,

Marie

Marie Désy-Field, cert. tr. OTTIAQ,

MITI, MCIL

Translation and voice-over

DésyField Ltd

Tel.: +44 (0) 20 8748 3436

Fax: +44 (0) 20 8741 4543

Mobile : 07747 637229

e-mail: marie@... (or marie@...)

www.desyfield.co.uk

[Guest guest]

Hello everyone,

Competitive enrollment implies competition between sites in a

multicenter trial. Sometimes financial incentives are used to

encourage enrollment completion. There is quite a bit of information

about this on the internet. Google " competitive enrollment " + trial.

http://www.clinicaltrialstoday.com/centerwatch_clinical_tria/2006/08/c

ultivate_your_.html

Pharma companies know they have to reach out to new and inexperienced

investigators to maintain capacity for growth in emerging regions.

Investigator capacity is a major issue in these markets because they

have experienced such significant growth in recent years. In the

U.S., though, companies have taken more of a sink-or-swim approach

when introducing physicians to clinical research, and they could be

making a big mistake.

In the U.S. new sites are often given a chance to participate in

clinical trials through competitive enrollment. If they meet patient

numbers by a deadline, then they participate. If not, they waste a

lot of time and energy for nothing, because often they don't get a

second shot at it.

Call it `natural site selection,' but it doesn't work. By offering

competitive enrollment, pharma companies are potentially cutting off

a new supply of qualified clinical research investigators before they

get a chance to contribute.

----

Cheers

Sue

>

> I guess it means that the patient has been enrolled in another

clinical

> trial, too. This is usually not allowed.

>

> Regards

>

> Charlotte

> -----Ursprüngliche Nachricht-----

> Von: medical_translation

> [mailto:medical_translation ]Im Auftrag von Marie

Desy-Field

> Gesendet: Donnerstag, 23. August 2007 11:25

> An: Medical translation group

> Betreff: TERM EN > FR competitive enrollment (clinical

trial)

>

>

> Dear all,

> I am translating a information and consent form for a clinical

trial. In

> the paragraph " Can I be removed from the study without my

permission? " it

> says:

> ...or for administrative reasons, including competitive

enrollment - the

> target number of subjects has entered the treatment phase. "

>

> I never came across " competitive enrollment " . Have you? If so,

what is the

> translation in French? Does it simply mean that the sponsor has

enough

> patients in the treatment phase and that there are no more space

for other?

>

> PS: the study comprises an open phase when the subjects receive

the actual

> treatment.

>

> Many thanks,

>

> Marie

> Marie Désy-Field, cert. tr. OTTIAQ,

> MITI, MCIL

> Translation and voice-over

> DésyField Ltd

> Tel.: +44 (0) 20 8748 3436

> Fax: +44 (0) 20 8741 4543

> Mobile : 07747 637229

> e-mail: marie@... (or marie@...)

> www.desyfield.co.uk

>

>

[Guest guest]

Sorry Marie - to answer your question, it means that the subject may

have been enrolled at one site, but if that site takes too long to

recruit the total number required and fails to meet the deadline, then

the subject may be excluded from the trial.

Sue