42 Publishing Clinical Studies

Anthony W. Fox

42.1 Introduction

This chapter has three objectives. First, it is neces-
sary to discuss the ethics and desirability of pub-
lishing clinical trials, andthe biases that may be
involved with that process. Second, younger clin-
ical trialists may benefit from some discussion
of classic parts of an orthodox clinical trial
report in a peer-reviewed journal, and some
clues for effective oral presentations. Third, alter-
native forms of publication are discussed, includ-
ing isolated abstracts and posters, electronic
publication and press releases. The scope of this
chapter is strictly formal publications: regulatory
documents (which are typically not published and
are a different form of clinical trials reporting)
and marketing materials are dealt with elsewhere.
Also, although the term ‘publishing’ is used to
describe the electronic submissions to regulatory
authorities, that subject belongs to another chap-
ter of this book. A summary and prospectus closes
this chapter.

42.2 Ethics in publishing clinical

trials

For all forms of publication, the objective usually

goes beyond the mere reporting of clinical trials

data. In some way or another, the pharmaceutical

physician will interpret his or her data to reach

conclusions, and will want to urge some change

in the behavior of the target audience. These

changes might include prescribing habits, health-

care resource utilization, public health policy or

regulatory practices.

Whatever the form of publication, the only tools

available to persuade people to make these beha-

vioral changes are the well-created document,

audiovisual presentation, press release and so on.

Often, the actual dissemination of these materials

takes place at a time or place remote from the

writer’s supervision. Publications must be well

made for stand-alone use.

Conclusions that extrapolate beyond the range

of available data are as inappropriate in scientific

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9