Biomedical Engineering Reference
In-Depth Information
institutes and even across trials within the same institute, poor effi ciency and
increased costs due to disparate and outmoded methodologies, and, as a result,
lack of the necessary speed with which certain medical situations should be
addressed. A practical example of potential problems can be seen from several
oncology studies in which inconsistencies were found between AE reporting/
publication and the raw data from the clinical trial databases themselves
[22, 23] .
There appear to be many independent initiatives and already established
systems throughout the federal government addressing aspects of AE report-
ing during clinical trials. Among them are new clinical trial guidelines on
reviewing and reporting unanticipated problems and AEs that occur in clinical
trials conducted or supported by the federal government [24]. Indeed, the
Federal Adverse Event Task Force (FAET), an interagency body composed
of representatives of the NIH, FDA, Offi ce of Human Research Protections
(OHRP), Centers for Disease Control and Prevention, Department of Veterans
Affairs, Department of Defense, and Agency for Healthcare Research and
Quality, has been established.
Moreover, to address the diversity of requirements solely within the NIH,
a Trans-NIH Adverse Event Task Force has been established and charged with
“proposing ways to harmonize the reporting policies of the agency's many
Institutes and Centers ” ( http://oba.od.nih.gov/policy/policy_issues.html ). In
addition to the Department of Health and Human Services' (DHHS) 45 CFR
part 46 and the OHRP's draft guidance [25, 26], the National Cancer Institute
(NCI) Cancer Therapy Evaluation Program has established the Common
Toxicity Criteria version 2.0 (CTC) and the Common Terminology Criteria for
Adverse Events version 3.0 (CTCAE) in attempting to delineate adverse-
event (AE) criteria. NCI CTC version 2.0 was the worldwide standard diction-
ary for reporting acute AEs in cancer clinical trials until August 9, 2006, when
the CTCAE version 3.0 was published. The CTCAE version 3.0, a Web-based
listing of AEs, includes AEs applicable to all oncology clinical trials regardless
of chronicity or modality. Building on the oncology CTC, the Outcomes
Measurement in Rheumatology (OMERACT) Drug Safety Working Group
has focused on standardization of assessment and reporting of AEs in clinical
trials and longitudinal and observational studies in rheumatology—the
Rheumatology Common Toxicity Criteria (RCTC) [16, 27, 28].
Despite all of these initiatives there is still no uniform, practical working
model that suits the needs of all parties. For example, the National Institute
on Drug Abuse (NIDA) has a Web-based system for serious adverse events
(SAEs), the Serious Adverse Event Tracking and Reporting System (SAETRS),
which is currently being used by about 30% of principal investigators (PIs).
The PIs are concerned about the security of the current SAETRS and the fact
that it appears easier to send an SAE report manually (by fax) rather than
logging into the system infrequently to report an SAE. The website AE system
is “ diffi cult to trust to collect confi dential information/data ('afraid of losing
data').” It is possible that if such a system were to be used for the more
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