We usually can re-word the publication language on 95% of our agreements
to remove most restrictions.  We also send sponsors a copy of the Sept
12, 2001 JAMA editorial about publication rights when they are reluctant
to remove restrictions.  This seminar by the Drug Information
Association (DIA) may be of interest.
http://www.diahome.org/Content/Events/02027.pdf

scott

Scott Davis
Sponsored Programs Administrator
University of Oklahoma Health Sciences Center

Tel:     405.271.2090
Fax:    405.271.8651
email:  xxxxxx@ouhsc.edu

-----Original Message-----
From: Elaine Brock [mailto:xxxxxx@UMICH.EDU]
Sent: Thursday, December 20, 2001 4:48 PM
To: xxxxxx@HRINET.ORG
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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 subscription information and a web-searchable archive, are available
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