Re: Clinical trial contracts Phyllis Thomas 21 Dec 2001 09:46 EST
This is a subject that's I can relate to at the moment.  The University of
Connecticut has recently opened up a Kinesiology Lab where clinical trials
happen all the time.  The contracts are horrendous which is frustrating
because as you've pointed out, data and patent ownership is pretty much a
moot point but as you're well aware, is it's there, we have to negotiate
it.  I've written my own boilerplate for either the PI's or myself to share
with the companies when given the opportunity.  It's attached for anyone
who's interested and I welcome any comments.  Thank you for bringing this
up!   Phyllis Thomas

At 05:47 PM 12/20/01, Elaine Brock wrote:
>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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Phyllis A. Thomas
Associate Director, Contract Services
Office for Sponsored Programs
University of Connecticut
14 Dog Lane, Unit 4133
Storrs, CT   06269-4133

Telephone: 860-486-8558
FAX:       860-486-8559
Website: http://www.osp.uconn.edu