February 2024 SOCRA Source Journal - Journal - Page 19
JOURNAL ARTICLES
Lessons Learned in
Establishing an Early Phase
Oncology Program at a
Community Research Site
Cindy Stoner, MCR, CCRP
Senior Clinical Research Coordinator,
Early Phase Oncology
Community Health Network
Indianapolis, IN
Cindy Stoner, MCR, CCRP
Abstract: Establishing an early-phase oncology program at a community hospital presents unique
challenges. Our site has lessons to share in our journey to provide innovative cancer care to our local
community.
The world of oncology
treatments has changed in the
past decade with the expanded
use of immunotherapy and
the continued development
of tumor agnostic therapies.
What remains constant is the
demanding complexity of
phase I clinical trials, especially
in oncology.1 In our network
of community cancer centers
based in Indianapolis, we
undertook the challenge of
establishing an early-phase
oncology clinical trial program
and have lessons to share as
we look back at our first year of
enrolling subjects.
Our first task was to complete
site selection visits with
sponsors to demonstrate that
we had the required resources,
including trained staff and
equipment to manage phase
I trials. Our research medical
director had previously
managed a phase I oncology
program in an academic
setting, and his prior experience
contributed to our ability to
assure sponsors that we were
prepared for the rigor of phase
I trials. We realized early on that
we needed to do a thorough
vetting of the protocols we
were offered to ensure we had
the resources required. We
presented each protocol to
our protocol review committee
that consists of physicians
from medical oncology and
radiation oncology as well
as research pharmacists and
senior research coordinators.
Among the details discussed
were the trial objectives and
if they fit with our current
standard of care, if we had
the trial population to meet
enrollment goals, and if we
had the resources to complete
time intensive procedures,
such as hourly blood draws for
pharmacokinetic samples.
Because one of the objectives
of phase I trials is to determine
the maximum tolerated dose,
there are many required
pharmacokinetic samples to
determine the absorption and
elimination of the investigational
drug. This means that subjects
are expected to stay in clinic
for as many as 8 to 12 hours
following dose to complete
blood draws as often as every
hour. Thankfully, our lab
assistants are very organized
and quickly developed a
standard operating procedure
for lab collection, including
separating the collection tubes
for each scheduled timepoint
into a bag labeled with the
timepoint and a space to enter
the draw time. The bags were
then placed in the clinic in a
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