Re: Clinical Trial Agreements Steinert, Bruce, W 16 Jun 2003 16:03 EST
I think there is some confusion about internal and external confidentiality. We have not seen this requested level of secrecy in our studies. Yes, the sponsors do not want their name, or the name of the drug/device advertised outside the institution. However, that has not restricted our use of this information internally for regulatory or oversight purposes. As to Charlie's issues, Big Pharma has always had the right not to submit data to FDA if new product didn't work. Adverse events get reported to the sponsor and the IRB whether or not the data is published or submitted for licensing. In fact, not reporting adverse events has resulted in the suspension of research at some very prestigious institutions. The informed consent form signed by the study subjects has to be approved by the institution's IRB and clearly state who is involved (sponsor, investigator, IRB, etc) and how to contact them (it also lists the study title, drug, proposed treatment indication, and full study title). Not publishing the existence of the study outside the institution keeps competitors from knowing the detail of the study. Have you seen the protocol titles lately? They are practically an abstract. At my institution, the Confidentiality Disclosure is signed by the CEO and binds all hospital staff and employees. The sponsor is well aware that details of the study will be disclosed within the institution (IRB, compliance, legal affairs, research office, etc) as needed for review and oversight. So far, that has not been an issue. Bruce Steinert, PhD, CCRA The Children's Mercy Hospital Kansas City, MO -----Original Message----- From: Charlie Hathaway [mailto:xxxxxx@AECOM.YU.EDU] Sent: Monday, June 16, 2003 3:26 PM To: xxxxxx@HRINET.ORG Subject: Re: [RESADM-L] Clinical Trial Agreements Gee, now doesn't this make make it much easier for big pharma, when asked about the results of a study that didn't flatter their concoction, to say, "What study??" But I suppose it also protects the university when patients who are injured by undocumented adverse events, or are simply not cured by worthless therapies, have no researchers to point the finger at. C. Hathaway "This, shipmates, this is that other lesson; and woe to that pilot of the living God who slights it. Woe to him whom this world charms from Gospel duty! Woe to him who seeks to pour oil upon the waters when God has brewed them into a gale! Woe to him who seeks to please rather than to appal! Woe to him whose good name is more to him than goodness! Woe to him who, in this world, courts not dishonor! Woe to him who would not be true, even though to be false were salvation! Yea, woe to him who as the great Pilot Paul has it, while preaching to others is himself a castaway!" ----Father Mapple, Moby Dick, Chapter 9 At 10:57 AM 6/16/03 -0400, you wrote: >Our Clinical Trials Office reports that 4 out of 5 pharma clinical trial sponsors are now insisting that the institution keep confidential the fact that we are conducting a particular clinical trial. > >In essence, they are saying that we cannot publish reports to the Board of Trustees and the State which contains the specifics of a clinical trial, e.g., study drug, indication, etc. In fact, they are insisting that our internal databases not contain this information. > >Is this a problem anyone else has encountered? > >Leonard P. Paplauskas >Associate Vice President for Research Administration >University of Connecticut Health Center >MC1920 >Farmington, CT 06030-1920 >xxxxxx@adp.uchc.edu (external e-mail) >xxxxxx@exchange.uchc.edu (internal e-mail) >860-679-3173 (phone) >860-679-1371 (fax) > > >====================================================================== > 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") ====================================================================== ====================================================================== 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") ======================================================================