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Advancing Data Collection: ePROs vs Traditional Paper Methods in Patient-Reported Outcomes

Clinical Trial Management

Electronic Patient-Reported Outcomes (ePROs) have increasingly become the preferred method for collecting participant data in clinical trials and healthcare settings, surpassing traditional paper-based Patient-Reported Outcomes (pPROs). This preference is based on several key advantages that ePROs offer over their paper counterparts, as evidenced by various studies and reviews.

Improved Capture Rates and Cost-Effectiveness

In 2022, OTA International published an article comparing the capture rates and costs of paper-based PROs (pPROs) and ePROs, concluding that ePROs have significantly better long-term capture rates than paper PROs while minimizing costs (Nguyen 212).

Enhanced Data Quality and Efficiency

A 2020 systematic review highlighted that ePROs are generally preferred over paper methods, improving data quality, resulting in similar or faster completion times, decreasing costs, and facilitating clinical decision-making and symptom management (Meirte, e15588).

Data Integrity and Compliance

According to CRO organization Premier Research, ePRO systems ensure greater data integrity with electronic timestamps and configuration options for data entry within specified time windows. This feature, along with input validation checks, improves data compliance (Spinner).

Patient Satisfaction and Safety

Premier Research also states that participants prefer ePRO systems over paper due to their ease of use and less missing data. Some ePRO systems also feature data monitoring that can trigger direct messages to patients if their responses meet certain pre-set criteria, enhancing participant safety (Spinner).

Time-Saving for Investigators

ePROs save significant time for investigators, automating assessment calculations in real-time, eliminating the need for manual tallying and scoring (Spinner).

Data Security

With ePROs, data is stored securely on servers with backups, reducing the risk of data loss or breaches.

FDA Preference

As indicated in the article “Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials”, the FDA has expressed a clear preference for the electronic capture of clinical trial data over paper-based methods, reflecting the regulatory body’s trust in the reliability and accuracy of ePROs (Coons 301–309).

Historical Consistency in Preference

Articles dating back to 2010, such as “ePRO vs. Paper”, have consistently pointed out the advantages of ePROs over paper-based methods, indicating a long-standing recognition of their benefits in the clinical trials and healthcare sectors (Manasco).

ePROs: Essential to Optimizing Clinical Trials

With improved data capture rates, cost-effectiveness, data quality, participant satisfaction, efficiency, safety, and security, the adoption of ePROs reflect the ongoing digital transformation in clinical research.

The Alethium Advantage

Built as a digital solution from the start, the Alethium eClinical Platform rapidly, reliably, and securely conforms to unique trial requirements with more efficiency at higher value. Leveraging a native eClinical platform improves participant engagement, enhances retention, and reduces trials costs.

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