Standards for certain restrictive provisions in clinical-trial agreements
with industry sponsors vary among academic medical centers, according to a
survey of medical-school research administrators responsible for negotiating
clinical-trial agreements with industry sponsors.
Greater sharing of information about legal relationships with industry
sponsors is desirable to build consensus about appropriate standards, said
Michelle Mello, J.D., Ph.D., lead author of the report, which appeared in the
May 26 New England Journal of Medicine.
Although industry sponsors provide approximately 70 percent of the funding
for clinical drug trials in the United States, little has been known about the
related legal agreements between industry sponsors and academic
The investigators mailed a structured survey to administrators at 122
institutions, 107 of whom participated in the survey.
Mello and colleagues found a high degree of consensus among administrators
about the acceptability of several contractual provisions relating to
publication of research findings. For example, more than 85 percent reported
that their office would not approve provisions giving industry sponsors the
authority to revise manuscripts or decide whether results should be
However, there was considerable disagreement about the acceptability of
provisions allowing the sponsor to insert its own statistical analyses in
manuscripts. On this question, 24 percent of respondents allowed them, 47
percent disallowed them, and 29 percent were not sure whether they should
allow such provisions.
There was also some variability in the acceptability of provisions allowing
the sponsor to draft the manuscript (50 percent allowed it, 40 percent
disallowed it, and 11 percent were not sure whether they should allow it) and
prohibiting investigators from sharing data with third parties after the trial
is completed (41 percent allowed it, 34 percent disallowed it, and 24 percent
were not sure whether they should allow it).
Disputes were common after the agreements had been signed and most often
centered on payment (75 percent of administrators reported at least one such
dispute in the previous year), intellectual property rights (30 percent), and
control of or access to data (17 percent).
"The heterogeneity of acceptability judgments among our respondents
raises the possibility that industry sponsors could `forum shop,' channeling
their studies to relatively permissive institutions," Mello and
colleagues said. "However, the degree of heterogeneity was relatively
small for some critical issues, such as whether sponsors could impose an
absolute publications bar, and in general, the data did not demonstrate strong
associations with observable institutional characteristics such as the volume
of clinical research and the percentage of research funding obtained from
They added, "The lack of clear indicators of permissiveness may
frustrate attempts to forum shop, although sponsors could still learn from
experience, word of mouth, and institutional culture and leadership that
countenanced permissive relationships with industry."
Robert Freedman, M.D., editor-designate of the American Journal of
Psychiatry, said that the issues raised in the NEJM article are
well known within the research community, but he emphasized the high degree of
compatibility across institutions, rather than the variability.
"What I find reassuring about the article is that the majority of
academic institutions subscribe to similar standards in their contractual
interactions with pharmaceutical companies," he said. "A high
degree of integrity is necessary for public confidence in the results of
clinical trials conducted under such collaborations."
More problematic are the practices of commercial contract research
organizations that "generally do not have oversight by governing boards,
such as boards of trustees, that can set policies for contracting," he
Freedman added that peer-reviewed journals, through the International
Committee of Medical Journal Editors, have enacted uniform standards for
reporting results of medical research that address many of the issues raised
in survey by Mello.
"For example, the senior author on a collaborative study must certify
that he or she has access to all of the data and wrote the paper,"
Freedman said. "In addition, through the Institute of Medicine, an
agreement between the journals and the pharmaceutical companies was recently
reached to register all clinical drug trials beyond Phase 1 on public
databases such as<clinicaltrials.gov>
before their initiation, to allow comparison of what is being reported with
the original design of the trial. This process prevents companies from
altering the plan for analysis of data after the completion of the
The American Journal of Psychiatry subscribes to this policy,
An abstract of "Academic Medical Centers' Standards for
Clinical-Trial Agreements With Industry" is posted at<http://content.nejm.org/cgi/content/abstract/352/21/2202?>.▪