February 2024 SOCRA Source Journal - Journal - Page 21
Many of our trials involve only
oral investigation treatment,
and those subjects are able
to spend their day in an exam
room. For the protocols that
involve IV treatment or an
injection, we have been able
to start a subject’s day in a
treatment room and transition
them to an exam room once
their infusion or injection is
completed. This requires a
hand-off from the treatment
nurse and communication
between treatment and
clinic nursing staff as well
as research coordinators to
ensure all parties know who
is responsible for remaining
blood draws and observing the
subject for reaction. We have
also developed a template
for checkout notes in the
EMR to alert scheduling staff
to research subjects and any
special scheduling needs.
For example, we would enter
“Return in 2 weeks for standard
and research labs, MD followup appointment, and 8-hour
investigational oral treatment
in blue flex room. Needs IV
started for PK draws.” This
indicates to the schedulers that
the subject does not need to be
scheduled in a treatment room
for IV treatment but needs to
be scheduled for 8 hours and
also alerts clinic management
that nursing staff will be needed
to start an IV hep-lock at the
beginning of the day for safety
labs and for timed blood draws
throughout the day.
Spending the day in the
oncology clinic is resourceintense for the subject as well
as the clinic. Many subjects
continue to work during their
treatment and must arrange
for time off work. Some are
also referred to our site from
other, more rural centers that
may not participate in research,
and travel to our site can be
a financial burden. Sponsors
may contract with companies
that provide reimbursement in
the form of a reloadable debit
card. For sponsors who do
not have a method of travel
reimbursement, our site has
begun negotiating a travel
reimbursement in our contracts
that allows us to be reimbursed
by the sponsor for gift cards
we provide to subjects to help
offset travel costs. Tracking
visits and the dispensing of
gift cards is a task that can be
completed by any research
staff member and does not
need to be performed by the
clinical coordinator, nor should
it be the responsibility of clinic
staff. We also provide cafeteria
vouchers for subjects and their
accompanying caregivers so
that obtaining food throughout
the day is not a concern.
Fortunately, our hospital
network has a charitable
foundation that provides
door-to-door transportation
for subjects in our county
with serious health concerns,
including any kind of cancer.
Early phase trials also require
more resources for our
regulatory and finance staff.
Many of these trials are a
dose escalation design with
many decision points built
into the protocol. Therefore,
these studies often require
amendments that must be
submitted to the IRB. Both the
sponsor and the research site
must be responsive to these
requirements that lead to
frequent protocol amendments,
consent updates, and
documentation of staff training.
The amendment must also
be reviewed for changes that
impact the contract and budget,
and additional negotiations
between site and sponsor may
be required to ensure the site
is compensated for additional
time and effort that may be
required to implement the
protocol amendment.
Communication and teamwork
have been key to our success.
As coordinators, we had to learn
the best way to distribute the
workload so that we could cover
long clinic days as well as attend
the multiple safety meetings
held by sponsors without
one coordinator carrying a
disproportionate amount of the
workload. Including the clinic
staff as members of the team is
important. We conduct an inservice for all studies and have
a huddle with clinic staff each
Friday for study updates. In
addition to clinic staff huddles
to discuss the resources needed
for each subject, we have a
huddle among the early phase
coordinators to assign subjects
for the following week. We
are also sensitive to staff and
participant needs. Our aim is
to divide the subject visits in
such a way that one coordinator
does not have multiple long
pharmacokinetic days in a
week and each coordinator has
a basic familiarity with each
subject and protocol. This
familiarity lessens the amount
of prep time required when
covering for a colleague and
also minimizes the disruption to
subjects since they are familiar
with a team of coordinators and
not just one staff member.
The complexity of inclusion
and exclusion criteria and the
SOCRA SOURCE © May 2023
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