Patient engagement plays an unmistakably critical role in the success
or failure of clinical trials. Keeping patients enrolled and active is
one of the biggest obstacles to study success faced by sponsors and
trial facilitators. Getting and maintaining patient buy-in for the
mission of the study is vital because dropouts and poor-performing
patient pools have the power to slow studies to a snail’s pace or fail
them outright.
Those of us that work in clinical trials are working hard to better
understand how to engage with patients. We are often very excited about
the potential of the new treatments being studied, but we need to
understand that we are handing patients a new category of
responsibilities – asking them to dutifully record dosing, meals,
changes in mood and many other bits of data. This can be stressful for
patients who are already dealing with at least one illness. For trials
to run efficiently, we need to give patients tools that allow them to
fulfill their role as seamlessly as possible. Not doing so, for whatever
reason, risks the integrity of the data collected. Very simply, those
running clinical studies who aren’t seeking out the most effective ways
to engage patients are doing so at the risk of their studies.
Turn to Technology to Help Make Patients’ Lives Easier
There are many ways that technology can help study teams engage with
patients. Some of the best tools utilize devices that most patients are
already familiar with, such as smartphones and tablets. These devices,
either those the patients already own, or devices provided by sponsors,
run applications that can greatly reduce the burden of trial
participation for patients while providing highly accurate data to study
teams. They are currently being utilized by many sponsors to address
two key areas where poor patient engagement can put trials in jeopardy:
medication adherence and reliable recording of symptoms.
Medication Adherence
Accurate collection of medication adherence, or dosing data relies
heavily on a patient’s ability to closely follow their treatment
regimen. This may sound straightforward, but clinical study treatment
regimens can be complex in their dosing instructions. Patients, like all
of us, can forget things, including when and how to take their
medication. Technology exists that provides reminders and easy to follow
dosing instructions through the patient’s device. These same
applications are able to tap into the smart device’s video recording
capabilities to record doses and send real-time reports to study teams.
Digital Symptom Recording: ePRO
In the past, patients were often tasked with keeping paper diaries to
record their symptoms, mood changes, meals and other facets that may
impact the effects of medication. While some patients may do an
excellent job of tracking every detail down to the minute, this is not
the case for most patients. We’ve all heard stories of patients trying
to remember and jot down two or more weeks of data into a diary while
they sit in the car outside the clinic. Technology like ePRO provides
prompts for patients who can then quickly and easily enter their data
into the application on a phone or tablet. This data is uploaded in
real-time and available for review by the study team.
How Technology Engagement Improves In-Clinic Engagement
With most clinical trials, in-person visits are spread out weeks and
sometimes months apart. What’s happening with patients in the times
between visits has always been a concern for study teams. This is why
the ability of technology, such as the medication adherence and ePRO
solutions already mentioned, to send a stream of real-time data
throughout the course of a study is so helpful. With all of this data
gathered in the days and weeks between clinical visits, clinicians can
use those critical face-to-face times to evaluate the whole patient,
understand their needs, and partner with them to remove any challenges
to success they may be experiencing. They can focus more on the personal
relationship with the patient versus interviewing and collecting
granular data by hand.
Patients participating in clinical trials are dealing with a lot. The inability to engage with these patients leads to dropouts and overall poor performance, which erodes data integrity and puts entire studies at risk. Continuing to use older approaches that rely heavily on patient recall and require time-intensive clinical visits and tedious manual data recording no longer makes sense.
Helping them by providing technology tools to ease their experience helps to keep them enrolled and actively involved. The tools are out there, and they’re working to improve both the patient experience and the quality of data.
