Achieving accurate endpoints for successful clinical trials necessitates reliable, high-quality patient-reported outcomes. Decentralized clinical trials (DCTs) are no exception. In fact, the digital and virtual components that define DCTs rely heavily on direct participant input and engagement—so much so that it’s vital to continuously optimize the process of data collection in order to ensure that electronic patient-reported outcomes (ePRO) translate into clinically validated results.  

When it comes to ePRO in DCTs, digital instruments are changing the game. These tools, made accessible to patients, improve data quality, streamline data collection, and reduce participant burden, allowing researchers to collect more data than ever before in real time.
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The Pitfalls of On-Site Data Collection  

The shift towards DCTs—though accelerated by the global health crisis—has been underway for years. However, many trials are still conducted using traditional methods: clinicians gather data from patients on site, often using paper questionnaires and face-to-face interviews.  

Although this method fosters trust between patients and clinicians, it does have pitfalls. Patients, being human, procrastinate. They complete their trial tasks at the last minute or fill in diaries right before appointments, which affects how accurately they can recall pertinent details.  

People also tend to be performative when they feel like they’re on display or on the spot—reflecting for an audience on what they’ve done or failed to do. Participants may hesitate to report actual behaviors and instead tell research teams what they think the experts want to hear. (Consider how easy it is to underreport the number of cocktails you have per week or exaggerate how often you floss your teeth.)

These challenges point to weaknesses in the traditional PRO collection model, which can compromise outcome accuracy and trial endpoints:

• Patient subjectivity, which impacts data accuracy and, subsequently, outcome accuracy.
• Participant burden caused by multiple site visits and the inability to report symptoms in real time, which hinders recruitment, drives drop-out rates, and prolongs study times.
• Outdated, suboptimal instruments that don’t capture the necessary quality or quantity of information, further impacting data integrity.
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Optimizing Data Quality and Participant Engagement

DCTs and hybrid trials can largely address these shortcomings—capturing PRO electronically through a wide range of next-generation digital instruments, including smartphones, clinical-grade sensors, wearable trackers, digital biomarker tools, and auxiliary devices such as pulse oximeters.  

Research teams can use digital instruments to gather data in real time, saving patients the time and effort required to manually input information into diaries or questionnaires. These instruments can record datapoints such as heart rate and exercise duration in the moment, reducing patient subjectivity and allowing teams to collect more unstructured data than ever before.  

Smartphones are one of the most powerful, patient-friendly tools available for clinical trial teams. Participants can use their own mobile devices to capture images, audio, and video, and immediately relay those outcomes to clinicians without personal interpretation. In this way, digital instruments improve outcome measurement while also enabling the rapid detection of adverse events.

Here are some examples of how unstructured data can enhance clinical findings:

• If a participant develops a rash while taking medication under testing, they can quickly snap and send a picture of it rather than relying on words to describe its appearance.  
• Caregivers can take pictures of their babies’ stools while changing diapers rather than having to refer to a Bristol chart to try to score the stool themselves.  
• When someone is trembling, they can capture video of the event so an expert can assess it.
• A digital instrument attached to an infant onesie can track infant fussing and cry duration in real time without relying solely on caregiver input.  

Trial teams can use a centralized platform that allows patients to collect data—including images, audio, videos, and medical documents such as test results—and upload it directly to a database for rating and annotation by expert scorers. Together, these devices and systems facilitate patient engagement and compliance while optimizing data quality.

An article published in the Journal of American College of Cardiology’s Basic to Translational Science outlines the advantages of digital tools, noting that DCTs could “potentially require smaller investigative teams, and lower costs to sponsors, in both training and full-time employees. Fewer inconveniences to patients/subjects due to virtual data acquisition helps to increase their willingness and ability to participate in a study, resulting in outcomes that better reflect the safety and efficacy behavior of the study drug in a ‘real world’ environment.”
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Looking Ahead  

Enhancing electronic patient-reported outcomes with digital instruments streamlines and accelerates data collection, making clinical trials more accessible and manageable for patients, clinicians, and sponsors alike. The implications also extend to point-of-care settings such as hospital systems. Healthcare organizations can leverage these devices to improve patient outreach and engagement, particularly as noncritical care moves from hospitals to home settings. Read more on ePRO Clinical Trials.
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Final Thoughts on Electronic Patient-Reported Outcomes

In the coming years, optimizing electronic patient-reported outcomes will drive the broader adoption of DCTs and hybrid trials, enabling sponsors and contract research organizations to refine data collection and integrity.  But, although DCTs have opened the data floodgates, more data isn’t the end goal—trial teams need to generate better data. Stay tuned for the next blog post where we’ll discuss how expert raters improve ePRO accuracy.  

Meanwhile, learn how technology can augment the data validation process.

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