publications, and nor do they belong in regulatory
documents or marketing materials. Omissions of
details in methods and results pursuant to a concise
presentation will always be subjective, and there is
a close link between the appropriateness of this
subjectivity and the integrity of the author(s).
The pressures on the clinical trialist, whether
writing himself or herself, or when guiding specia-
list medical writers, are many, sometimes contrary
to common standards of integrity, and often ema-
nate from powerful people who lack the training
needed to assess data objectively. Such people will
include journalists who oversimplify or sensatio-
nalize, marketing department staff wanting to
amplify positive messages and silence negative
ones, and corporate officers who want to use pub-
lications as vehicles for enhancing the share price
or negotiating better financial arrangements on
Wall Street. Rarely, even government politicians
get involved, whose tactics include those used by
journalists, the diligent application of complete
ignorance, and the forced fit of technical informa-
tion to a predetermined political position.
The publication of clinical trials, then, is one
example where the clinical trialist (acting as pub-
licist or medical writer) may become an agent for
social change (Gray, 1994). Even when he or she
acts solely as a medical writer, authors physician
mustunderstand theirethicalresponsibility torepre-
sent the material in a fair, balanced, and, above all,
accurate manner. While an ombudsman-like role
may help in finding compromise among the various
pressures that are applied to this process from
diverse outside parties, the author of a clinical trial
report may inevitably (but hopefully only occasion-
ally) find himself or herself as the sole repository of
integrity in this process; this can feel lonely, but
nobody else is going to fulfill this role.
42.3 Desirability of, and biases
in, the publication
of clinical trialsEverybody finds the publication of anidealclinical
trial to be highly desirable. Clinical development
departments find it efficient to mail out reprints in
response to clinicians’ inquiries and to append
them to Investigators’ Brochures and IND amend-
ments. Regulators controlling promotional prac-
tices need only satisfy themselves that the
publication accurately reflects the report that has
been submitted to the approved PLA or NDA.
Marketing departments can use these publication
for promotional purposes, knowing that the data
is cast-iron, the message is unarguably positive,
and that the self-evident benefits of the drug will
be understood by the most skeptical clinician
meeting the least adept sales person. Lastly, senior
management can bask in the glory of its contribu-
tion to the public health, and direct observers on
Wall Street to the appearance of its clinical trials
in the world’s most respected medical journals.
For small companies, this might even be life
saving. How on earth could such a laudable activ-
ity go wrong? The answer, of course, lies in the
fact that many clinical trials are less than ideal
candidates for publication. These poor publication
candidates may be trials that did not result in a
positive outcome, or those that generated data
about some prosaic aspect of drug action (e.g.
tolerability in a special population). Studies repli-
cating a positive finding are often a regulatory
requirement, but me-too papers do not find
homes in prominent journals. Lastly, some good
studies are less than ideal publication candidates
solely because the manuscript has been drafted
badly.
Negative trials are rarely accepted for publica-
tion by good journals unless their results seriously
dispel some previously held belief, or contradict
previously published studies. Some areas of ther-
apeutics are notorious for the high proportion of
negative clinical trials results (e.g. pharmacologi-
cal treatments for depression). However, the
majority of negative clinical trials are those
where either drug efficacy is simply not evident
or where no difference is found between two active
treatments. Negative data are the inevitable result
of conducting clinical trials that are true experi-
ments; there is nothing dishonorable in such a
result, even if it is disappointing. However, the
failure to publish such studies risks waste offurther
resources and duplication of the patient hazard,
needed for an independent study group to discover566 CH42 PUBLISHING CLINICAL STUDIES