Re: Clinical trial contracts Davis, Scott 21 Dec 2001 11:24 EST
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 ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================