Biomedical Engineering Reference
In-Depth Information
will have to be tailored to each stakeholder group and incentives offered to
upload models. Also, simplifi ed versions of models can be made available at a
greatly reduced price and free for students/professors. To address issues of
confi dentiality, models can be made available via username and password,
incorporating secure sockets layer (SSL) encryption mechanisms for users/
modelers with this concern. To assure quality, models can be vetted by an
expert advisory panel or expert users.
28.3 COLLABORATIVE ADVERSE - EVENT DETECTION AND
DRUG SAFETY DATABASES
The institutes of the National Institutes of Health (NIH) have sponsored or
executed innumerable clinical trial programs over the years and continue to
do so. Nevertheless, one of the most important aspects of trial management is
the detection, reporting, and analysis of adverse events (AEs), which have,
unfortunately, not been adequately standardized with regard to defi nitions,
reporting forms, processes, and treatment of the data. AE reporting is some-
what more standardized in these regards for the postmarketing environment.
The U.S. Food and Drug Administration (FDA) has formal regulations and
systems for dealing with serious medical reports in a somewhat more consis-
tent fashion (e.g., manufacturers send AE reports to the FDA either on stan-
dardized paper forms or, more recently and increasingly, through electronic
reporting under defi ned specifi cations; patients or health care professionals
can submit reports through the MedWatch program) [20].
The postmarketing environment in the United States also includes the FDA
Adverse Events Reporting System (AERS) database as a repository for all
such reports. Still, the problem of timeliness of identifi cation, risk assessment,
reporting, and dissemination of information about AEs persists within post-
marketing surveillance as well. Indeed, Sentinel Network is intended to be an
integrated, electronic nationwide medical product safety network which is
supposed to combine the efforts of both the public- and private - sector post-
marketing safety surveillance tools and methodologies into one cohesive
system. However, the FDA's progress with development of Sentinel Network
has been slower than anticipated.
The lack of adequate standardization within the NIH was highlighted on
the NIH's Clinical Research Policy Analysis & Coordination website [21]:
“Tremendous diversity exists among AE reporting requirements promulgated
by various federal agencies, as well as among the NIH Institutes. This hetero-
geneity is a challenge for investigators, institutional review boards, and
sponsors, who may face multiple requirements regarding the content, format,
and timing of reports that must be made to different agencies and oversight
bodies.” The lack of a systematic and consistent standard with regard to
AEs within the NIH could have important implications: less than optimum
protection of trial subjects, inability to merge and understand data across
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