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University
of Pittsburgh Cancer Institute
UPMC Cancer Centers
Abstract:
Principal
Investigator:
Samuel
A. Jacobs, MD
Clinical Professor, Department of Medicine
University of Pittsburgh School of Medicine
UPCI Associate Director for Clinical Investigations
UPMC Cancer Centers
This
proposal is to develop a community (network) model for
conducting and enhancing patient participation in early phase
clinical trials. In our model, the academic cancer center
remains the focal point for these studies, which will be made
available at selected community sites. To accomplish this
goal, a number of barriers will need to be clearly elucidated
and overcome. Since the vast majority of early phase clinical
trials are currently conducted at academic medical centers
under the direction of academic faculty, faculty attitudes and
concerns about extending their trials to community sites will
need to be explored and barriers overcome. For our clinical
faculty, i.e. community-based oncologists/hematologists, who
choose to participate in early phase clinical trials, this
will be a new effort. Despite having experience in cooperative
group and phase II/III pharmaceutical trials, these physicians
and their staffs have not participated in early phase clinical
trials. Their attitudes and concerns about participating in
these trials will need to be defined and are likely to include
perceptions about faculty-clinical faculty interactions, their
own lack of time, training, and resources. In addition,
patient barriers that exist in the community setting that up
to this time has prevented wider participation in early phase
clinical trials will be investigated. Based on our assessments
to date, community-based oncologists perceive that patient
barriers to increased participation include age, comorbidities,
poor understanding of the clinical trials process, and the
fear and expense of leaving the community to travel to the
academic center. Procedures will be developed to measure
attitudes and changes in attitudes, develop the needed
infrastructure to provide closer links between the academic
center and community-site, the necessary on-site resources to
conduct safely and completely these trials, and to develop
outreach programs within the community sites to increase the
awareness, understanding and availability of early phase
clinical trials.
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