Using Technology to Engage with Patients in Clinical Trials
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.
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.