Sep 10, 2018
Joanne Riemer, RN, BSN, is a research nurse at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital. She is a member of the Training & Education Working Group.
I have been a research nurse at Johns Hopkins Medical Institution
since 2010. Within six months of starting my position, I began
working with checkpoint inhibitors. From my vantage point in
clinical trials research, I’ve seen many changes in immuno-oncology
trials patient selection over the last eight years. All studies define the
population to be evaluated and questions the study hopes to answer.
Each study defines the disease, the stage, the line of therapy, the
performance status, and wash out periods from prior therapy. (The
wash out period is a specified amount of time that must go by after
the last dose of previous therapy.) In the case of checkpoint inhibitors,
as our knowledge about these agents has grown, we’ve seen study
requirements and eligibility criteria become much more specific.
Before a patient can be considered as a trial candidate, the
patient, caregiver, or provider must be aware of study’s existence
and feasibility. It is up to the study team to get the information out.
At Hopkins, the primary investigator or a study team member will
attend tumor boards to explain upcoming trials and eligibility criteria
to providers. More recently, genomic testing results have started
to list actionable mutations and clinical trials associated with those
mutations, which can assist providers and patients in the search
for treatment. Sponsors have been advertising trial enrollment
opportunities on TV, referring viewers to websites for more
information. All of this takes time and dedicated communication.
My first checkpoint inhibitor study was a phase 1 trial, open to five
different disease groups. The study required archival tissue or biopsy
for testing at screening. The description of the sample was more
flexible than many of my current studies. Today multiple biopsies at
different points during a study are the norm. Core specimen size is
clearly defined; studies require larger samples and more core biopsies.
Fine needle aspiration specimens are not permitted. If largegauge
core specimens are needed, the method of obtaining biopsies
may be dictated. For example, with lung biopsies, obtaining cores via
a bronchoscopy may be possible with special needles, but may also
not be a possibility. CT-guided specimens can have an element of risk
depending on the location of the mass. Increasing the core gauge
and number of cores may increase the risk of pneumothorax. The
fixative, temperature, and fixation times for specimens have become
more defined. Laboratories running these studies have had to adjust
practices. Baseline samples may require evaluation by a central lab
prior to enrollment. Others require pathologist confirmation that a
certain percentage of tumor is present in block or slides. Some of
these changes have led to prescreening periods and procedures.
Besides tissue, study protocols outline the scans, labs, EKGs,
ECHOs, prior treatments allowed or prohibited, and the time frame
permitted before enrollment. Ordering and scheduling multiple
tests can lead to a lengthier screening period.
Before patient consent to participate in a study can be obtained,
insurance clearance is necessary. Depending on the payer’s process,
this can take days or weeks. Other challenges to enrollment may
include travel and expenses, as well as the patient/caregiver's ability
to conform to the protocol’s schedule.
Despite our progress, many different types of cancer need more
effective and tolerable treatments. Clinicals trials continue to be
the path to advance our understanding of cancers and to improve
How are you talking to your patients about
IO clinical trial opportunities?