Ghislaine Mathieu <xxxxxx@BVAR.ULAVAL.CA> writes:

>We are discussing with a company a research project involving human
>experimentation and it looks like if  this company does not want to bear all
>the necessary costs, asking us instead to charge the patients a minimum fee.
>Does anyone has any experience with  such procedure?  This company told us
>that this was the way they were usually working with american universities.
>Up to now, we were never asked such "condition".

>Ghislaine Mathieu
>Tech Transfer Office
>Universite Laval
>email  xxxxxx@vrr.ulaval.ca
>fax 418-656-7785
>tel 418-656-3525

I don't quite understand the particulars of the issue you are negotiating
with the pharmaceutical company, but keep in mind that the tactic of saying
that other institutions "have agreed" (to whatever issue is being negotiated)
is one of the oldest in the armamentaria which pharmaceutical companies use.
Typically, they'll say this about any issue they wish to dispense with a
minimum of negotiation, knowing that investigators will use such vague and
unsubstantiated statements to pressure their administrations to accept the
company's terms.  My rule of thumb ito employ a healthy dose of skepticism
whenever presented with such generalizations.

What pharmaceutical companies do the U.S. is to tell investigators that
$X/patient is all they have to spend, a statement which probably has some
truth in that this is how companies budget their trials.  However, whether
they only have $X/patient or $Y/patient to spend is the question you need
to doggedly pursue.  My bet is that the company will prefer to negotiate
those terms with the investigators, who typically try to get their institution
to bend to the company's terms.

My experience has indicated that company's look for three major factors in
deciding to go along with a particular institution in a clinical trial.  I'll
list them in the order I think is most important to the company, but this is
based only on my impressions, not on any evidence.

 1.  The number of patients which any given institution is able to
 enroll in the trial.  The more patients, in the least amount of
 time, is probably the most important criterion to the company,
 because at this stage their principal objective is to gather the
 data needed for regulatory approvals.

 2.  The cost of the trial at a given institution.  They'll try to
 keep the per patient cost as low as possible, but if they see that
 your investigators can enroll a lot of subjects quickly, they'll
 be more amenable to negotiating more favorable financial terms.

 3.  The experience and qualifications of the investigator.  Alas,
 this is usually the least important factor, but nevertheless one
 which is taken into account.  The FDA (Food and Drug Administration,
 in the U.S. the agency which regulates the drug industry) does tend
 to scrutinize data from "known" investigators with less rigor than
 it does data from "unknown" investigators.

I hope that my rambling on this topic may be of some use to you.  It is
interesting, and instructive, to learn that pharmaceutical companies seem
to operate similarly on both sides of the "pond".

"L"
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xxxxxx@neuron.uchc.edu                                           |
xxxxxx@sun.uchc.edu                                            |
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