Keeping track of patients in clinical trials has always been
challenging for sites and sponsors. However, the COVID-19 pandemic has
taken the challenge of patient engagement to new levels. Patients with
fatty liver disorders such as nonalcoholic steatohepatitis (NASH)
present numerous obstacles to program compliance in the best of times.
Patient education is a challenge with all cohorts regardless of disease
state. Compounding this difficulty is the fact that NASH patients
usually suffer from multiple morbidities such as diabetes, metabolic
syndrome, high blood pressure, high cholesterol, and others. COVID-19
has further complicated things by causing these patients to be wary of
in-person clinical visits.
The bright-side of all of this is that the pandemic is forcing all of
us – sponsors, study sites and the patients themselves – to get more
comfortable with technologies that keep us connected, keep patients
engaged in the study and keep the data flowing. This has been so
important as we all seek to unlock new, safe, and effective treatments
with promise to help the millions of people impacted by fatty liver
diseases.
Technology to Maintain Personal Connection
Productive face-to-face interactions between clinicians and patients
plays a significant role in the success (or failure) of any clinical
trial. Physicians need to be able to put hands on patients and examine
them with regularity in order to get a complete picture of the patient’s
health and well-being. That said, it can be weeks in between clinical
visits, and COVID-19 may serve to space clinical appointments out even
further. While that in-clinic time is important from a physical
examination standpoint, it can be difficult for study investigators to
assess what patients have been doing in the days and weeks since they
were last in front of one another. It’s not uncommon to learn in a
follow-up appointment that a patient ceased their medication three or
four days after the first dose, or that they’d been taking their
medication incorrectly.
Remote engagement technologies are useful in helping to fill those
information gaps. Site teams can interact with patients remotely in a
number of ways, including televisits (either by phone or video
conferencing) or through applications downloaded on a smartphone or
tablet. Regular check-ins using these types of tools go a long way in
keeping that personal connection between the study team and the patient.
Constant Monitoring
We at study sites have long wished for solutions that help us know what’s happening with patients when they’re not with us. As I mentioned before, many study clinicians have gotten used to getting unpleasant surprises in follow-up visits. Now, we can implement technologies that help to let us know quickly when adherence issues pop up. This way, we can reach out to the patient remotely and troubleshoot in the hopes of getting them back on track. To accomplish this, we’ve employed a range of options, all with their own sets of benefits for patients and data collection.
Fitness Trackers
Wearable devices that track patient activity and even diet history
provide important data from NASH patients. Increases in physical
activity can be signs that the medication is having positive effects on
the patient’s energy level. Fluctuations in physical activity might
identify the need for our study teams to check in with patients in case
there might be a problem.
Tablets
Tablet devices can make it easier for patients to enter their
patient-reported outcomes. Filling out this critical information can be a
burden for patients, so any technology that makes it quicker and more
straightforward will help produce better data.
Remote Medication Adherence Applications
Those of us at sites have long wished for solutions that let us know
about patient adherence issues earlier, so that we’re not surprised in
follow-up visits. Technology that helps patients remember when and how
to dose and gives our study teams confirmation of dosing is useful. With
this technology, we’ll know when a patient misses doses almost as soon
as it happens, and we can then reach out to that patient – by phone,
e-messaging or through smart device applications – to learn why a dose
or doses were missed and work with them to find a solution.
Patients with fatty liver diseases participating in clinical trials
can pose unique difficulties for study teams to manage. Technologies
that make it easier for them to follow the study protocol are extremely
useful. With COVID-19 further complicating issues by keeping some
patients away from in-person clinic visits, these technologies which can
help study teams engage patients remotely have become increasingly
important. Maintaining high levels of patient engagement in trials has
always been more important, and today’s pandemic adds to the challenge.
By using remote technologies to help facilitate patient-clinician
interactions, sites can help maintain the vital connection between
patients and caregiver.
For more information about how technology can help impact NASH patients in clinical trials, watch our webinar, Considerations for Remote Assessment in NASH Studies.
