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)
>
>
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