Advancements in technology have resulted in an increase in interest
around Virtual Trials. Due to the COVID-19 pandemic and concerns about
trial continuity as well as the ability to start new trials, many in the
industry became more willing in 2020 to employ virtual approaches to
patient interaction and data collection. Because of this, we as an
industry have learned a great deal about what a Virtual Trial actually
is. One key lesson we’ve learned is that, even with the many advanced
technologies we can put to work to engage patients and collect data
remotely, clinical study sites still play a critical role.
Relationships Matter
In my experience, trials always go better when there are personal
relationships between patients and their care team. This is a piece of
the clinical research puzzle that can’t be duplicated with approaches
that are 100% virtual. At the beginning of a study, in particular,
patients want to meet and talk with their doctors and nurses in person,
and vice versa. Human beings are wired for three-dimensional
communication. We are social beings adept at picking up on visual cues
like body language and facial expressions. These can be difficult to
pick up in a totally virtual environment, typically a two-dimensional
computer or smart device screen. Making a point to begin patient
engagement in-person helps to solidify the personal connections between
patients and clinicians.
From a data collection perspective, this also allows the care team to
explain the nuts and bolts of the study in detail while getting a sense
of whether the patients (and family members or other caregivers) are
truly understanding what will be expected of them, if they’re feeling
overwhelmed and if they will need more or less support throughout the
course of the study.
Once these vital face-to-face meetings have taken place and the
relational foundation is set between patients and the clinical study
teams, it then makes sense to employ Virtual Trial technologies to
create channels for communication and engagement that are easy for
patients and the study teams to use. In this way, technology can be a
powerful complement to, and facilitator of, the important work being
done by the sites.
Powering Sites and Empowering Patients
Remote engagement and monitoring technology are useful in reducing
some of the burden of in-person visits. Patient histories can be
collected virtually through remote visits and certain types of study
data can be gathered remotely and shared with clinical teams in
real-time. For example, remote applications can gather dosing data with
high accuracy, as video technology available on today’s smartphones and
similar devices can record each dose and confirm adherence. Wearable
devices and electronic diaries can also be utilized to provide a
constant stream of high-quality data for study teams. An additional
benefit to having this real-time data is that study teams can optimize
their in-person visits with patients. Many times, these visits can be
spread out weeks at a time and relying solely on patient recall of their
activity between visits can produce less-than-clear data. With
technology at work monitoring this activity, the study teams will
already have access to it when the patient is with them in the clinic.
This allows them to focus on patient well-being and on providing the
right level of support for each patient, strengthening the relationship
which helps keep patients engaged in the study and can help with
retention.
At the same time, giving patients a tool for helping to manage their
own trial burden helps to keep them active and involved. Patients
participating in clinical studies have a lot to deal with beyond their
study responsibilities. They have work and family obligations and often
have other health issues they’re dealing with besides the disease state
that brought them into the study. Having a technological helper to
lessen the burden of what can often be complicated treatment regimens
can make a big difference with patient engagement. Additionally, having
an always-open channel to the site team when support is needed is
another great benefit for patients.
The connection between patients and their site-based study teams is irreplaceable. For studies to be successful, patients need to feel comfort and trust with their care providers and study teams need to understand the levels of support patients need to be successful. Virtual Trial approaches can be both effective and useful in collecting and analyzing study data, but to unlock their true potential, they should be partnered with tech-savvy sites who know how to use these tools to strengthen patient relationships.
