I very much agree. Another complicating factor is that they often add
language indicating that the terms of the agreement are confidential--which
would add difficulty to efforts to share language.
We, of course, try to delete any data ownership clauses that say the company
owns them; if that fails, we add a statement that says we retain the right
to use the data and results for our own clinical, academic, and research
purposes and to exercise our rights and fulfill our obligations under the
contract.
As you know, defining the data as theirs, then requiring confidential
treatment of their information may preclude publication of study results
(I'm certain company lawyers are not unaware of this inconsistency in
language.)
We do many clinical trials, and I'm also VERY concerned about the onerous
language we are seeing in them. CRO agreements are even worse! I'd be very
happy to participate in a "national discussion" on this topic.
Luckily, there are some companies out there that have a clear respect for
academic institutions and our concerns and that are NOT so difficult to deal
with . . . but we're seeing more and more of the others, too.
Debbie Smith
Deborah (Debbie) L. Smith, Ed.D.
Director, Research Administration
UT Health Science Center
8 So. Dunlap, Suite C-109
Memphis, TN 38163
(901) 448-4823
(901) 448-7600 fax
xxxxxx@utmem.edu
----- Original Message -----
From: Elaine Brock <xxxxxx@UMICH.EDU>
To: <xxxxxx@HRINET.ORG>
Sent: Thursday, December 20, 2001 4:47 PM
Subject: [RESADM-L] Clinical trial contracts
Colleagues, I am increasingly concerned about the apparent
degradation in the quality of contracts that pharmaceutical
companies (with or without intervening CROs) are offering
universities. We routinely receive contracts in which the
sponsors claim ownership of data and results as well as
intellectual property.
Although we are significantly more lenient in the negotiation
of intellectual property terms in clinical trial agreements
(owing to the mootness of the issue) than we are in other
sponsored projects I am concerned that clinical trial sponsors
now have an expectation of data ownership and confidentiality of
results.
Are you all experiencing this as well? What are you doing
about it?
Does anyone have a decent agreement with Alza, for instance?
I would like to see some sort of national level discussion on
this topic to determine where the parameters are. Maybe even to
share agreements and concerns with our pharmaceutical sponsors
with the dream of creating a Uniform Clinical Trial Sponsorship
Agreement.
Data control seems to be an issue that journal editors and
others are talking about. Maybe we should be talking about it
too.
I promise to step down from this soapbox long enough to read
your responses and ideas.
Happy Holidays to you all.
Elaine L. Brock
Associate Director, Research Admin.
Director, Med School Tech Transfer & Corp Research
University of Michigan
3003 S. State St., Rm, 1072
Ann Arbor, MI 48109-1274
Phone (734) 936-1289
FAX (734) 764-8510
xxxxxx@umich.edu
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