We periodically participate in multicenter trials in which the
Sponsor attempts to delay publishing until all data from all sites
has been gathered and analyzed. Some of these agreements are written
in a way that seems to place the Sponsor in control over release and
ultimate publication of the information and results.
In such cases we attempt to add language indicating that our
Investigators will be free to publish his/her results within a
reasonable period of time (approximately 1 year) following the
completion of his/her portion of the study. For example, we would
insert language similar to the following: " However, in no event
shall the Investigator's legitimate right to publish be delayed
beyond December 31, 1996" for a study which we expect to be completed
locally in December, 1995.
Lately, we have found that more Sponsors are taking the position
that the publication paragraph is something that they do not wish to
negotiate on an individual site basis because their "standard
publication language" is included in the protocol and/or has been
agreed to by other participants. We remain unwilling to allow a
Sponsor to unilaterally control whether the study results are
published.
We would be interested in learning how other universities are
handling this problem.
Thank you for your time.
Cathy Berg
Washington University
St. Louis, MO.
xxxxxx@medadmin.wustl.edu