hello rita,
here are below the 4 kinds of deals that I can think of in our "small"
French hospital:
1) the company meets the "directeur" (ie the big chief) of our hospital
before the trial begins, and a financial deal is thus settled between our
hospital and the company; our lab has just to do the work for the patients
in the trials as we do the work for any other patient in our hospital
2) in some cases, the company does not really need our work but simply needs
us to send the samples to a central lab; in this case too, a financial deal
is settled between the "directeur" and the company, we just do the sampling
work and send the samples
3) in some cases, the company only deals with the physicians, and in such
cases neither the lab nor the "directeur" know what is going on; in such
cases, the physicians is the only one who earns something, at the expense of
the hospital regarding lab data, and other data (imaging for example)
4) in our lab, the only case when lab doctors can earn some money with the
companies is when it is a trial about measuring susceptibilities of bacteria
to antibiotics; in such case, the money is generally divided in three parts
(because we are three lab doctors here)
in short: (1) our hospital can earn some money this way, but not always; (2)
many physicians can earn some money, as long as they are willing to spend a
lot of time gathering heaps of data in their files, and (3) we (lab doctors)
seldom have this opportinity (except in bacteriology, but not very often),
the situation for the lab doctors may be different in some big university
hospitals; when I was working in Paris, a very long time ago, some of the
lab consultants (respected experts in their fields) were able to earn quite
a lot of money this way with the companies (not enough though to buy big
roll royces! they had to be satisfied with jaguars only!)
best regards to all,
Dr Joseph Watine, PH, AIHP, PharmD, AAHU, EurClinChem
Laboratoire de Biologie Polyvalente
Centre Hospitalier Général
12027 Rodez Cedex 9
France
>From: Andrea Horvath <[log in to unmask]>
>Reply-To: Andrea Horvath <[log in to unmask]>
>To: [log in to unmask]
>Subject: labs contribution to clinical trials
>Date: Wed, 16 Aug 2006 16:47:34 +0200
>
>Dear Colleagues,
>
>I am sure many of you are involved in providing lab results for patients
>taking part in drug trials. Could you please provide some info on the
>procedures or regulations of the lab's participation in clinical trials?
>I am particularly interested in the followings:
> * How are labs reimbursed for these studies? Do you have a separate
>contract with the drug company as a lab, or is your institution having one
>trial contract and reimbursement of tests is done internally?
> * Do doctors, who request the tests, always make it clear if a lab test
>is for routine or study purposes?
> * Do you get reimbursed for all lab tests done for the patient in the
>trial and as prescribed in the trial protocol, or only for those tests that
>are above the "routine" management of that patient?
>My question may sound silly or strange to some of you, but we came across
>several drug companies that want to pay only for those "tests that are not
>normally requested for the general and routine management of the patients'
>condition". In the lack of detailed guidelines or protocols for lab testing
>in every single condition, how one can define what would otherwise be
>standard practice and what is extra testing for trial purposes?
>
>I must admit that I find this a rather doggy area and in my view, if a drug
>company has a study protocol which involves all kind of lab tests, and
>they use those results in their trial (plus they ask for your lab
>certificate and quality documentation on those), then they should cover the
>costs of all tests in the protocol, irrespective whether some of those
>tests would have been done anyway or not.
>
>Could colleagues help us in the Central-Eastern European region with their
>views on this tricky issue? Your input would be highly valued as I have a
>worry that drug companies come East because regulations are tighter and
>costs are higher on the West than in the Eastern countries...
>
>Many thanks: Rita
>
>Prof. Andrea Rita Horvath, MD, PhD, EurClinChem, FRCPath
>Secretary of EC4
>Chair of the Committee on Evidence-based Laboratory Medicine, IFCC
>President of the Hungarian Society of Laboratory Medicine
>Department of Clinical Chemistry
>University of Szeged
>Albert Szent-Gyorgyi Medical and Pharmacological Centre
>Somogyi Bela ter 1, Szeged
>H-6725, Hungary
>
>Tel: (+36)-62 545 770
>Fax: (+36)-62 544 559
>mobile: (+36)-20 332 7290
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