Press releases
Pharmaceutical physicians in large pharmaceutical
companies will only very rarely be exposed to the
need for press releases concerning their clinical
trials. In contrast, the small entrepreneurial pharma-
ceutical company may live or die on the outcome of
a single clinical trial. The rapid dissemination of the
results of such a clinical trial to the appropriate
audience (shareholders and investment community)
is legally required when material to the prospects of
a small, public company. The press release then
becomes an important tool for publishing clinical
trial results.
When writing press releases, absolutely no
technical knowledge can be assumed on the
part of the recipient. Often their questions parse
simply to ‘Did the drug work or not?’ Extended
detailed explanations can actually create the false
impression that the drug did not work, when in
fact the trial outcome was quite satisfactory for
product registration purposes. Equally, when
clinical trials fail, ingenious but scientifically
meaningless explanations by corporate officers
can create the false impression that the outcome
was better than it was. A good example is the
often used: ‘We still have confidence in our abil-
ity to register Drug X; Drug X performed as we
expected, but it was just that the placebo response
rate in this [pivotal] study was unexpectedly
high.’
Clinical trialists may often want to avoid invol-
vement in the drafting of press releases altogether.
However, this creates a liability that one’s indepen-
dent comments may not then dovetail with the
company’s press releases, causing harm not only
to the company but also to one’s longevity
within it!
The best advice on press releases may be two-
fold. First, avoid scientific nuance and technical
detail. State clearly whether or not the primary
objective of the clinical trial was met. Which-
ever the case, then state clearly the implications
of these data to the clinical development plan: if
it needs redirection, the state what that redirec-
tion is, and the implication for the registration
timeline.
Copyright
Copyright exists to prevent the exploitation of a
publication (or trade mark) by anyone other than
the publisher. This protection of the right to exploit
a publication is central to the promotion of publish-
ingper se, and thus an incentive to disseminate free
speech.
In most developed countries, copyright can
exist in two forms. First, for a fee, the protected
publication can be registered with the national
office of copyright. Second, the copyright holder
can simply assert in the publication ownership of
copyright under the Common Law. Both forms
may use the familiar#symbol. The registered
copyright is easier to enforce in court because the
date of registration and priority of first publisher
are on independent record and can be compared
to the behavior of the alleged infringer. The
Common Law alternative can also be legally
enforced, but requires the development of a set
of evidence; an infringer usually has at least an
initial defense that due search of the national
register failed to locate the alleged infringed
copyright.
It is a peculiar and remarkable aspect of aca-
demic journals that their publishers make a profit
while receiving almost all their copy entirely
for free. Almost all journals require transfer of
copyright from authors to publisher upon accep-
tance of submitted manuscripts. Technically, this
requires that an author needs specific permission
from the publisher to use his own manuscript
later; in practice, this permission is routinely
granted upon written application. A few journals
now seek only exclusive licenses from authors,
one condition of which preserves the author’s
right to personally use his own work, and which
leaves copyright ownership with the author(s);
the license can also become void if the publisher
fails to exploit it, and can yield royalties to the
authors. In practice, this license removes the
administrative burden of granting routine permis-
sions by the publisher, and royalties on journal
reprints are either nominal or absent.
But there are exceptions. Copyright for pub-
lications is not universal. In the United States,42.4 THE CLASSIC COMPONENTS OF A CLINICAL TRIAL REPORT IN A PEER-REVIEWED JOURNAL 571