Guest guest Posted August 23, 2007 Report Share Posted August 23, 2007 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 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 23, 2007 Report Share Posted August 23, 2007 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 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 23, 2007 Report Share Posted August 23, 2007 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 > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 23, 2007 Report Share Posted August 23, 2007 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 Quote Link to comment Share on other sites More sharing options...
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