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Agreements for Industry-Sponsored Clinical Trials Often Fail to Protect Researchers’ Independence

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Duke Health News 919-660-1306

Durham, N.C. -- Academic medical centers frequently engage
in industry-sponsored research that fails to adhere to
international guidelines established to protect the integrity
of research and the rights and interests of academic
investigators, according to a study published in the Oct. 24,
2002 issue of the New
England Journal of Medicine
. This failure to adhere to
guidelines regarding trial design, access to data, and
publication rights could pose a variety of risks to
investigators and research participants.

Researchers at the Duke University Medical Center and the
Duke University School of Law found that agreements between
academic medical centers and industry often do not uphold the
revised guidelines issued in October 2001 by the International Committee of Medical
Journal Editors
(ICMJE). The ICMJE guidelines are used by
more than 500 medical journals as a standard for researchers
submitting papers for publication.

"We didn't expect to find full compliance with the
guidelines, but we were surprised by the extent to which the
agreements entered into by medical schools did not protect the
independence of investigators in clinical studies and the
integrity of their research," said Kevin A. Schulman, M.D.,
professor of medicine at the Duke University Medical Center and
lead author of the study. "This is the first study to look at
compliance with the new ICMJE guidelines, so we hope it will
offer medical schools a road map for how they might improve
their agreements with industry sponsors."

The study was funded by the Duke Clinical Research
Institute
.

The Duke team surveyed 108 member institutions of the
Association of American Medical Colleges (AAMC) from November
2001 through January 2002 to assess the extent to which their
contracts with clinical trial sponsors complied with three main
provisions of the ICMJE guidelines, specifically:
· whether authors of reports of multicenter trials had access
to all trial data;
· whether the authors or an independent committee controlled
editorial and publication decisions; and
· whether investigators were fully involved in the design and
conduct of the trials.

The Duke team found that academic medical centers'
agreements with industry sponsors rarely included such
provisions: only 1 percent (median score) of agreements
required that authors of reports from multicenter studies have
independent access to all data from the trial, though
institutions serving as coordinating centers for multicenter
trials stipulated this level of access at a higher rate (50
percent of contracts). While agreements at both local sites and
coordinating centers secured access to data from their own site
in most trials, the Duke researchers say this is not adequate
to fulfill the ICMJE standards.

"Many institutions and investigators assume that having
access to site-level data is enough to guarantee the integrity
of the study," said Robert M. Califf, M.D., director of the
Duke Clinical Research
Institute
and senior author of the study. "But publishing
data, positive or negative, that are collected at a single site
as part of a multicenter trial is not sound scientific
practice. The number of patients enrolled at a single site is
almost never large enough to yield statistically significant
results."

Industry sponsors also typically control decisions regarding
the publication of data from clinical trials, according to the
researchers. Provisions addressing editorial control of
multicenter manuscripts appeared in 40 percent (median score)
of contracts, while an independent publications committee and a
guarantee of publication were specified in less than 1 percent
(median score) of contracts. The agreements also did not ensure
dissemination of findings from research on stored biologic
materials collected during clinical trials. These materials are
often collected during trials for potential future
research.

"Institutional agreements often fail to ensure researchers'
access to the final data from clinical trials, and there is
also no guarantee that the collected data will ever be
published or made available for professional use," said study
co-author Jeremy Sugarman, M.D., director of the Center for the Study of Medical
Ethics and Humanities
at Duke University Medical Center.
"Patients often participate in clinical trials not only for
personal benefit, but also because they believe they are
contributing to scientific knowledge as a whole. If trial data
are not made available to others, this may break an implicit
promise to research participants that their contributions will
be used in such a way."

The Duke study also found scant adherence to the ICMJE
recommendation for the participation of investigators in the
design of trials. Only 2 percent required the presence of an
independent executive committee as a condition of participation
in a trial, and only 1 percent required a data and safety
monitoring board.

The authors note that while current compliance is low, the
ICMJE recommendations provide a framework to improve academic
freedom and integrity. "To ensure that research is being
conducted in the best interests of the public -- that positive
and negative trial results are being published and made
available to the scientific community -- academic medical
centers as a group will need to require that their contracts
with industry comply with the ICMJE guidelines," said
Schulman.

Joining Schulman, Califf and Sugarman on this study were
Damon M. Seils, Justin W. Timbie and Kevin P. Weinfurt, Ph.D.,
of the Center for Clinical and Genetic Economics; and Daniel B.
Mark, M.D., of the Outcomes Research and Assessment Group, all
of the of the Duke Clinical
Research Institute
at Duke University Medical Center; as
well as Lauren A. Dame, J.D., of the Center for the Study of Medical
Ethics and Humanities
at Duke University Medical Center and
the Duke University School of Law.

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