UP FRONT
This communication with other members
of the health-care team sets hematology/
oncology apart from many other disciplines.
In fact, other disciplines typically do not have
dedicated research nurses because the care
is not complex enough to require them. But,
with our oncology patients, the care is extremely complex and multidisciplinary. Without a nurse to coordinate and shepherd all of
that through the clinical trials process – while
also keeping the involved parties in the loop
– patient safety (and study protocol) could
never be maintained.
That collaboration is a hugely overlooked
part of the clinical research puzzle: Everyone
who comes into clinical contact with that clinical trial patient also needs to be cognizant of the
research protocol to understand the implications
and special considerations of the trial. This is
especially important for providers who care for
our patients, but may not be formal investigators on the clinical trial. Clinical care trumps the
protocol every time, but we need to make sure
the defined protocol is being followed.
ferent from the standard therapies? How
many visits do I have to make? How am I
going to feel? How many side effects am I
going to have?”
Our job is to put all the information
swirling around into perspective so patients
can wrap their heads around joining a trial,
weighing the pros and cons to decide if it is
the right choice for them. And we are not
always successful in our efforts; research
nurses can spend hours talking to a patient
about a clinical trial, and he or she ends up
never getting enrolled in the trial.
Simply getting patients comfortable with
the idea of participating in a trial is another
hurdle. When they hear the word “trial,” patients may feel like lab rats. First-time patients
are the most difficult to convince, but once a
patient has been in a trial, he or she becomes
accustomed to the process and usually wants
to continue participating.
The interaction with patients occurs at every level. This becomes even more important
for clinical trial patients who are likely receiv-
The work we do, while it can be burdensome, is critical to moving science
forward and keeping patients safe. It also
offers the ultimate reward: the ability to
improve the lives of patients for years to
come by being part of the drug approval
process. Most people in health care do
not get to experience that.
Collaboration and education, therefore, is
constant. Our goal, above everything, is to keep
the patient safe, but clinicians also need to keep
the limitations in mind.
Priming the Pump
With so many moving parts and the participation of so many people, there are plenty of
opportunities for mistakes, setbacks, and missteps. The greatest challenge to making clinical
trials run smoothly is getting patients enrolled
– without them, there would be no trials.
There is no method for easily and accurately capturing the amount of (occasionally
fruitless) work that goes into enrolling a patient
into a clinical trial. Principal investigators
tend to look at hard numbers (i.e., “How many
patients have we put on this trial?”), but may
forget the behind-the-scenes work that goes
into each and every one of those patients from
start to finish.
We are there at the beginning to answer
patients’ initial questions: “What is this
study about? Why is my doctor telling me
that I should consider this study? What are
these drugs doing? How is the therapy dif-
ASHClinicalNews.org
ing an un-approved, investigational drug. With
“Dr. Google” on call, we also have to counteract
outside forces to provide accurate and trustworthy information, and to direct the patient
or the family to good sources outside of the
research nurse.
Pulling Double-Duty
In hematology/oncology, it is impossible to
unbundle research from routine patient care
– so much of what we do for clinical trials is
actually administering routine patient care.
Patients on clinical trials, though, will often
require visits that are above and beyond routine care. Advanced practice practitioners are
typically the provider seeing these patients
over and over again.
Everyone in the hospital is working under
their own time constraints, but that struggle is
amplified when adding in the research arena.
For instance, take the additional limitations
and documentation requirements and add
those to regular clinical care, then multiply
that manifold to reflect the target enr