Principles and Practice of Pharmaceutical Medicine

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manuscripts from federal employees cannot be
claimed as proprietary because their work product
is deemed always to belong to the general public,
whether published or not. Most journals operate a
copyright exemption system for this purpose. In
many Third World countries, copyright, if it exists
at all, is unenforceable.
Reprints disseminated for medical informa-
tion or marketing purposes should be those
purchased from the publisher. Alternatively,
photocopying license fees can be paid, and in
the United States a national clearing house exists
for this purpose.
Every website page can potentially be copy-
righted. Few are actually registered, although asser-
tion of Common Law copyright is common. So far,
there has been insufficient litigation to delimit the
copyright aspects of electronic publishing.


Summary and prospectus


In summary, the construction of a clinical trial
report for use in the peer-reviewed literature is
much like that for any other scientific paper; it
must contain most of the things that would appear
in the executive summary of a clinical report used
for regulatory purposes. Clues for effective oral
presentations are also provided. Systems for pub-
lication of clinical trials are currently neither
comprehensive nor universally available to the
relevant target audiences. Pharmaceutical compa-
nies and journal editors both introduce publication
bias; the former is likely only to expend resources
in reporting, and the latter is likely only to publish
clinical trials with positive outcomes. Registration
of clinical trials was suggested more than 15 years
ago, as one method for avoiding the bias against
publication of negative trials. Some pharmaceuti-
cal companies are beginning to provide such
registries for their own work, but no internation-
ally coordinated or funded agency has yet
emerged except in specialized areas with rela-
tively small academic audiences. It is possible
that electronic publication can improve this situa-
tion, but, at present, there is more optimism than
proof that this is the case.


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572 CH42 PUBLISHING CLINICAL STUDIES

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