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CDER News Along the Pike
September 15, 2006
Volume 12, Issue 1
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Office of
Surveillance and Epidemiology
Contracts expand
rapid evaluation
of newly marketed drugs
By Judy A. Staffa, Ph.D., R.Ph.
In the Office
of Surveillance and Epidemiology, we have strengthened our ability
evaluate the safety of newly marketed drugs faster and more
effectively. In September, we awarded four contracts at $1.6 million
a year that give us access to databases that include more than 20
million patients in different geographic areas and include special
populations. These contracts provide for up to five years of access
to data resources that can be used to:
-
Conduct safety analyses to benefit the public health.
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Respond in a timely manner to urgent public safety concerns.
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Provide a mechanism for collaborative pharmacoepidemiological
research designed to test hypotheses, particularly those arising
from suspected adverse reactions reported to us.
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Enable our rapid access to U.S. population-based data sources to
ensure public safety when necessary.
In the past,
our collaboration with researchers who have pharmacoepidemiologic
databases was through a cooperative agreement or grant mechanism.
This same type of research collaboration to conduct
pharmacoepidemiologic studies will now occur through a contract
mechanism. This will give us more flexibility and access to a wider
range of data resources. The contractors and their unique resources
are:
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Kaiser Foundation
Research Institute
has large, fully integrated databases, some dating back to 1981,
representing all 6.1 million current Kaiser Permanente members in
northern and southern California. The Kaiser databases are linked
annually to state vital statistics and cancer registry files.
Electronic records will be fully
implemented in 2006.
-
I3 Drug Safety
has access to claims data on a very large, geographically diverse,
insured population having a total membership of 12 million (United
Health Care). This contract also allows us to use i3 Drug Safety’s
new Web-based tool that allows us to quickly assess the
feasibility of many drug safety studies relating to new molecular
entities. Some laboratory data are also available.
-
Harvard Pilgrim
Healthcare
represents a large experienced HMO research network of eight
health plans geographically diversified within the states of
Massachusetts, Maine, Minnesota, Washington, Colorado, Georgia and
New Mexico having a total membership of 3.2 million. Electronic
medical records are available for six of the eight sites.
-
Vanderbilt University
represents small but ethnically diversified, state Medicaid
populations who are medically at high risk, such as those with HIV
infection, the poor, psychiatric patients and nursing home
residents. These data represent 2.2 million recipients in
Tennessee and Washington. This site includes data as far back as
1974 in Tennessee and also has linked maternal-child, cancer
registry and other encounter files.
Judy
Staffa is project officer for the contracts and a lead
epidemiologist in the OSE Division of Surveillance, Research and
Communications Support.
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Views and opinions expressed are those of the authors
and do not necessarily reflect official FDA or CDER policies. All
material in the Pike is in the public domain and may be
freely copied or printed. Deadline for submitting articles is the
15th of each month.
Date created: September 14, 2006 |
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