4 Advantages of Using ePRO in the Clinical Trials Process

During a clinical trial, it's important to collect as much relevant data as possible about how well the treatment is working and the patient experience. There are many tools and services out there which exist solely for this purpose; the hope is that more data can be collected without unnecessarily inconveniencing the patient and empowering them throughout the process.

One of these tools is electronic patient-reported outcomes (ePRO): patient-provided information about symptoms, side effects, drug timing and other questions recorded on an electronic device during a clinical trial. Below are a few ways in which study participants and research teams can benefit from the use of an ePRO solution.

1. Better experience for study participants

One common way to use ePRO in a trial is through out-of-the-box mobile apps which study participants use on their own smartphone or tablet. It's typically a positive patient experience because reporting outcomes this way tends to be as accessible and intuitive as the apps that users are accustomed to using on a daily basis to check social media accounts, banking, the weather, and beyond. With mobile apps, patients also have the opportunity to provide additional information. Today, it's possible for them to include photos, videos, and geolocation directly into an electronic case report form (eCRF) or survey.

As another example, task reminders are an important component of ePRO platforms. Filling out a patient diary or taking some other action and having the ability to quickly and easily act on that reminder provides patients with a more guided and straightforward process. It also encourages compliance, so less crucial data goes unreported.

Employing the use of ePRO also prevents the need for study participants to visit a clinic in order for research teams to gather certain types of information. Instead, they’re able to submit their results remotely - virtually any place and any time. Fewer scheduled clinic visits lessens the burden on patients and can contribute to reducing study drop-out rates.

2. Greater efficiency for study participants and research teams

Far quicker than could be accomplished with paper diaries and surveys, ePRO can also shorten the timeline of gathering outcomes from patients. Once a study participant completes an eCRF or survey, the results become available instantaneously in the study database. This allows research teams to access and analyze the data immediately.

Push notifications or text reminders serve as a great method to keep patients on track with reporting their outcomes. Research teams may also deploy notifications to keep patients informed of information related to the clinical trial. Ultimately, this not only helps increase the volume of pertinent data collection, but regularly engages the patient in the study, bringing them closer to their treatment.

3. Real-world data, greater patient safety

New advances in smart watch technology and other wearable devices offer the opportunity to improve patient safety, too. For instance, one particular ePRO solution is designed to utilize Core Motion technologies and Apple's HealthKit to collect real-world data in the clinical trial process, including heart rate, step motion, and range of motion.

Apple's recently released Apple Watch Series 4 is equipped with a new FDA-approved ECG feature, which intermittently measures heart rate and classifies heart rhythms. Using the ECG app, the Watch is capable of recognizing abnormal rhythms, such as atrial fibrillation, and can immediately generate a notification. Enabling patients to take routine heart measurements has the potential to aid in detecting adverse events (AEs) and serious adverse events (SAEs).

The latest Apple Watch also comes with a fall recognition functionality powered by wrist trajectory analysis and impact acceleration. When these technologies are implemented in a clinical trial with ePRO and research teams receive immediate notifications, they will be able to respond to SAEs quicker than ever, which can lead to greater safety measures for patients. Google's own Wear OS watch will likely follow suit in all this as well.

4. Trial cost reduction

Aside from the advantages offered to the trial data itself, an indirect goal of ePRO is to lessen the cost of data collection and data monitoring. Eliminating the need for sponsor-provisioned mobile devices assigned to each patient, combined with no need to track and control devices (e.g. lost, stolen, or broken), automatically lowers the cost. If site visits are not needed and the data is collected directly at the source, this leads to more streamlined timing and expenses.

Additionally, ePRO may reduce data duplication and mistakes that occur when collecting outcomes from patients. Data is inputted into standardized eCRFs and populates directly into an EDC system or CTMS, which cuts back drastically on transcription errors. This is because the electronic version of the form is capable of cleansing the data and being responsive to the way questions are answered, where only the pertinent data is collected.

In turn, this reduces the resources that must be dedicated to data cleansing. These resources can then direct their attention to other elements of a trial. In the end, the cost of the trial is brought down and the treatment is that much closer to manageable cost on the market upon its approval.

As mobile and wearable technology continue to proliferate the clinical research landscape, we’ll see ePRO playing a role in more and more studies. And, as the patient-centric movement gains further momentum, this technology will grow in importance. Learn even more about how to use ePRO in clinical trials today.