relationships with commercial entities for full
transparency.
37.6 Access to ongoing clinical
trial informationIncreasing scrutiny of clinical trial data emanat-
ing from the industry, academic and government
sectors has led to an important evolution in access
to information concerning ongoing clinical trial
data and knowledge of the status of publication of
completed clinical trials. Dialogue amongst the
three major entities involved in these types of
studies has led to new processes that have been
established by pharmaceutical companies to
assure increased transparency of clinical trial
conduct and communication of results. This has
taken the form of three related methods of com-
munication of trial metrics.
A web site has been established by the FDA
whose informational and timing provisions were
outlined in Section 113 of the Food and Drug
Administration Modernization Act (FDAMA),
provides continuously updated information con-
cerning the existence and purpose of federally
and privately supported clinical trials, such as
those conducted at pharmaceutical companies
(www.clinicaltrials.gov). The trials listed are
those that are ongoing or had been completed
since January 2004. Information available includes
the name and purpose of the study, brief entry or
exclusion criteria indicating who may participate,
participating investigative sites including contact
information and status of enrollment.
A second source of information regarding clin-
ical trials was established with a different goal by
the Pharmaceutical Research and Manufacturers
Association (PhRMA). In 2004 PhRMA launched
a Clinical Results Database (www.ClinicalStudy
Results.org) to provide a central repository for
clinical trial results, positive or negative, of
‘hypothesis testing’ clinical trials involving mar-
keted drugs. The goal of this industry-initiated
effort was to have substantial information available
via electronic database concerning all studies
completed after October 1, 2002. As full publica-
tion clinical study results may be delayed by the
complicated process of manuscript acceptance by
journal editorial boards, the purpose of this repo-
sitory database was to enhance the transparency of
clinical trial results and expedite their communica-
tion. By July 1, 2005 all new studies meeting the
criteria established by PhRMA, and by September
13, 2005, all ongoing clinical trials were to be
listed.
A final source of information for the public
concerning the status of clinical trials was estab-
lished by individual pharmaceutical companies
to allow prospective patients’ access to knowl-
edge concerning the availability of clinical trials.
The exact web addresses can be obtained by
searching company-specific web pages. Such
web sites fill a third need – to help an individual
patient make an educated decision about partici-
pating in a clinical trial. Usually these web sites
include a listing by disease and study number of
ongoing clinical trials, a brief description of the
precise disease category being studied, the pur-
pose of the trial, the key entry and exclusion
criteria and the treatment arms and duration. In
addition links are provided to study specific web
sites, and supplemental information about the
disease being studied, its manifestations and
how it is diagnosed are included. Questionnaires
are also often available which can be completed
by patients to identify eligible patients and pro-
vide information concerning the nearest location
of a clinical trial site.37.7 Summary
Medical Affairs departments design valuable and
often extremely creative trials that provide
important later phase information about clinical
research conducted with soon-to-be-marketed or
already marketed drugs in regard to their relative
efficacy compared to others of its class, new
information concerning efficacy in related indi-
cations and additional safety and efficacy data
that supplement the core data which led to origi-
nal approval. Because the type of research con-
ducted in this later phase is often in response to
residual questions about safety as part of phase IV
commitments agreed to upon original approval,526 CH37 MEDICAL AFFAIRS