Re: Clinical trial contracts Debbie Smith 21 Dec 2001 09:59 EST
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 ====================================================================== 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") ======================================================================