research at all levels, the approach today is much
more robust and defined, largely driven by industry-
initiated efforts to make access to clinical trial
results more transparent. As this is not mandated
by federal laws, but has been guided by academic
groups interested in effective communications and
clarity about the roles of listed authors on manu-
scripts (i.e. CONSORT guidelines), the approach
can vary slightly from company to company, but
usually takes the form of both online communica-
tion usuallyviacompany-sponsored web sites as
well as disclosure by publication in abstract form
with presentation at national scientific meetings.
Because the publication of a paper describing
the results of a clinical trial is not guaranteed by
journals, which accept papers for publication
based on interest to the readership as well as the
scientific methodology involved, the full commu-
nication of trial results in the form of a peer-
reviewed manuscript may be delayed for some
time after receipt of the final statistical report.
Moreover, sometimes the data are available, the
focus is commonly on preparation of abstracts for
scientific meetings,which needtobe submitted as
early as one year prior to their presentation, and
on the preparation of a detailed clinical study
report (sometimes several hundred pages in
length), containing all data from the trial, which
are incorporated into the dossier submitted to
regulatory agencies. Thus, communication in
the form of abstracts and online publications, as
well as the full disclosure of clinical trial results
to regulatory agencies has acquired increasing
importance in the process of data communica-
tion. In addition the use of public web sites to
provide access to additional trial information has
been recently implemented (see below).
In addition to such forms of publication, it
should be noted that health authorities in the
United States and other countries are also
informed as to the design and goals of all clinical
trials conducted by pharmaceutical companies,
and are sent final protocols prior to the study
investigator meetings. This allows time for
these health authorities to comment on the
same and suggest modifications to the design of
trials, if needed, based on their specific scientific
goals. In addition, communication of safety
information from clinical trials beyond phase
III is incorporated into Annual NDA Safety
Updates which are also submitted to health
authorities for purposes of ongoing safety mon-
itoring of newly marketed drugs.
Another purpose of conducting clinical trials in
phase IIIb is to provide practicing physicians with
information concerning efficacy or safety of drugs
soon to be in the market relative to other drug
comparators. Trials of this sort, if performed with
prespecified aims, outlined in a clinical study pro-
tocol, conductedviaGCP standards and meeting
prespecified study hypotheses relevant to the dis-
ease state being treated, can be submitted to a
division of FDA which has responsibility for drug
promotion – the Division of Drug Marketing,
Advertising and Communications (DDMAC).
This agency also regulates direct-to-consumer
advertising and is responsible for approving
presentation to the public of clinical trial datavia
promotional materials.
The usual procedure for obtaining regulatory
approval for the dissemination of promotional
detailing information that can be presented by
sales associates directly to physicians is for the
clinical trial results to be submitted to DDMAC
along with proposed language, advertisements or
detail aids which describe the study results. Such
descriptions need to demonstrate balanced pre-
sentation of the efficacy and safety in treatment
of indicated medical conditions. Analogous to the
registration of drugs for marketing approval, the
process can be lengthy, requires careful review of
the dossier, often with input from the division
originally responsible for approval of the NDA,
supplemented by interactions in the form of dis-
cussions among scientific, regulatory and commer-
cial associates and DDMAC. The final output
usually takes the form of a pamphlet or handout
which can be left with the physician by the sales or
marketing personnel, which details the clinical
trial results. Alternatively, trial results can be in-
corporated into direct-to-consumer advertising
efforts, as appropriate. FDA can also require
various types of action if promotional efforts are
deemed inappropriate. This sometimes takes the
form of letters which are directed to consumers
or to practicing physicians, developed in order to37.2 PHASE III AND PHASE IIIB STUDIES 521