In modern clinical trials, participant-reported data is essential for evaluating treatment safety, efficacy, and tolerability—especially in studies where symptoms, side effects, or quality of life play a central role. Electronic patient-reported outcomes (ePRO) systems streamline the process by collecting this information through digital platforms like smartphones, tablets, or web portals.
ePRO improves data accuracy, higher compliance, and more efficient workflows for sites and sponsors. It's now a widely accepted standard across therapeutic areas and a valuable asset in traditional, hybrid, and decentralized trials.
ePRO tools give trial participants a way to report on symptoms, medication side effects, functional status, or health-related quality of life directly through an electronic interface. These platforms are designed to capture data in or near real-time, often using:
Data collected via ePRO is automatically time-stamped and securely transmitted to a central server. From there, it integrates with a study’s EDC platform or clinical trial management system (CTMS), reducing the need for manual transcription or reconciliation.
Depending on the protocol, ePRO entries may be completed:
This direct line of communication with the participant ensures investigators have accurate, timely data to support decision-making at every stage of the trial.
ePRO platforms eliminate the variability and errors often associated with handwritten responses. Time-stamped entries reduce the chance of backfilling, and skip logic assures that patients only see questions relevant to their condition or treatment. The result is cleaner, more reliable data that’s ready for analysis with minimal intervention.
ePRO results in compliance rates that are difficult to achieve with paper forms. Built-in reminders, intuitive interfaces, and the convenience of completing entries from home all contribute to better adherence. For trials with symptom diaries or quality-of-life assessments, this consistency is critical to maintaining data integrity across the study population.
Sites spend less time chasing down missing entries or transcribing forms into the EDC system. Real-time data monitoring allows sponsors and CROs to identify and address issues as they arise—whether it's a trend in reported adverse events or a dip in compliance at a specific site. For trials on tight timelines, these efficiencies translate into faster, more confident decisions.
When participants have an easy way to report how they feel and see that their input is valued, engagement tends to improve. ePRO gives patients a structured way to contribute meaningfully to their care and helps build trust with the study team. This engagement is key to patient retention.
Originally developed to improve data accuracy and patient compliance in research, ePRO is now being used across healthcare systems to support real-time symptom tracking, enhance communication, and improve health service outcomes—especially for those managing chronic or complex conditions.
One of the most well-documented ePrO applications in clinical care is in clinical oncology. For cancer patients undergoing treatment, symptom burden can change rapidly and significantly impact quality of life. ePRO tools allow patients to report fatigue, nausea, pain, or other adverse effects between visits—enabling care teams to respond more quickly than traditional follow-up protocols would allow. Studies supported by the National Cancer Institute have shown that integrating ePRO into oncology care pathways improves treatment adherence, reduces emergency room utilization, and can even extend lifespan in some cases.
Beyond symptom monitoring in oncology, the use of ePRO is expanding into a wide range of conditions, including dermatologic diseases like alopecia, respiratory illnesses such as COPD and metabolic disorders like diabetes. In these areas, routine symptom reporting through digital platforms helps clinicians better understand day-to-day patient experiences and make more timely, informed decisions.
As more healthcare providers adopt digital health strategies, ePRO continues to serve as a bridge between clinical research and clinical practice—bringing the benefits of structured, patient-reported data into everyday care delivery.
ePRO data collection tools and platforms can be used to collect:
By combining flexible delivery methods with centralized data aggregation, study teams can make sure that data collected—regardless of source—flows into a single database for real-time comprehensive analysis.
While ePRO has clear advantages, successful implementation requires planning and coordination. Important considerations include:
Failure to address these areas early in the trial design process can result in delays, protocol deviations, or missing data—undermining the value that ePRO is designed to provide.
At Remington-Davis, we provide the operational infrastructure, patient support, and protocol-driven oversight needed to keep trials running smoothly. From data collection to participant engagement, our team maintains compliance, minimizes disruptions, and helps support your study’s integrity.
Learn more about how we can support you as a clinical trial management partner. Contact us today.
ePRO platforms allow participants to document symptoms as they occur, rather than waiting until the next site visit. This is especially important in trials where severe or worsening symptoms may indicate safety concerns or the need for a protocol-mandated intervention. Real-time alerts can notify investigators when symptom thresholds are met, enabling faster clinical response and improving health outcomes.
Not all randomized clinical trials require patient reported outcomes, but they are increasingly used—especially in studies evaluating quality of life, symptom control, or treatment tolerability. Regulatory agencies like the FDA often look for patient reported outcome measures when evaluating the patient experience. Their inclusion can strengthen submissions by offering direct evidence of patient outcomes from the participant perspective.
Accuracy starts with training—both for participants and site staff. At the site level, we confirm that patients understand how to use the system and know when and what to report. Built-in logic, time stamps, and validation rules help standardize entries and minimize recall bias.
Electronic patient reported outcomes (ePRO) are especially valuable in the follow-up phases of a randomized controlled trial, where continued data collection is critical but in-person visits may be infrequent. ePRO platforms allow participants to report symptoms, medication use, and quality-of-life metrics remotely—ensuring consistent data capture without placing additional burden on patients or sites. This approach helps preserve clinical outcomes data across extended timelines.
Electronic patient reported outcomes are widely used across therapeutic areas and patient populations, but their appropriateness depends on thoughtful, intentional implementation. In many randomized controlled trials, ePRO systems have proven effective for capturing reliable patient reported outcomes in both adult and pediatric populations, as well as in chronic and acute care settings.
That said, considerations such as age, digital literacy, physical limitations, and access to technology must be addressed. For example, in older adults or patients with mobility impairments, options like interactive voice response systems (IVRS) or site-based data entry can improve accessibility.