The Evolution of Electronic Patient Reported Outcomes (ePRO) in Clinical Trials
In today’s healthcare landscape, patient engagement and outcomes play a central role in assessing the effectiveness of clinical trials.
Traditional paper-based methods of collecting patient-reported outcomes (PRO) have proven to be inefficient and prone to errors.
However, advancements in Internet-based technology have given rise to electronic patient-reported outcome (ePRO) software, revolutionizing data collection in clinical trials.
In this article, we will explore the evolution of ePRO in clinical trials, its benefits for researchers and patients, and its potential to improve the overall quality of data collection.
The Limitations of Paper-Based PROs
Historically, paper-based PROs have been the primary method of collecting patient-reported data in clinical trials.
However, numerous studies have highlighted the limitations of this approach.
Patients often provide untimely, incomplete, or illegible data through paper-based methods, leading to data inaccuracies and delays in analysis. 
Additionally, paper-based diaries can be easily manipulated, with individuals back- or forward-filling entries, skipping questions, or providing illegible responses. 
These issues compromise the integrity and reliability of the collected data.
The Rise of ePRO in Clinical Trials
Recognizing the shortcomings of paper-based PROs, researchers and clinical study sponsors have increasingly turned to electronic solutions.
ePRO systems provide a more structured and efficient method of data collection, ensuring accurate and timely reporting by patients.
The use of ePRO in clinical trials has grown significantly over the past 15 years, with studies demonstrating higher data quality and subject compliance compared to paper diaries. 
Benefits of ePRO in Data Collection
The adoption of ePRO software in clinical trials offers several advantages over traditional paper-based methods.
Firstly, electronic data collection reduces the likelihood of errors and missing data.
ePRO systems enforce data completeness by requiring patients to answer all questions and preventing out-of-range responses.
Moreover, ePRO enhances patient compliance and engagement.
Patients find electronic surveys more convenient and user-friendly, resulting in higher response rates. 
The accessibility of ePRO platforms through smartphones and tablets allows patients to participate in clinical trials regardless of their geographical location, promoting inclusivity.
Types of ePRO Collection Methods
There are three main categories of ePRO collection methods: Interactive Voice Response Systems (IVRS), screen-based reporting devices, and mobile messaging solutions.
- Interactive Voice Response Systems (IVRS)
IVRS is a telephone-based system that allows patients to record responses using a touch-tone keypad.
Similar to customer care menus, IVRS offers automated calls and customizable features.
IVRS is easy to deploy, scale, and navigate, making it suitable for trials with a large number of participants. 
- Screen-Based Reporting Devices
Screen-based ePRO involves the use of electronic devices such as smartphones, tablets, computers, or wearable medical devices.
Patients access software on the device, answer questions, and the responses are digitally recorded.
Screen-based ePRO can be used in the patient’s home for timely data collection or in a supervised clinical setting.
Web- and app-based ePRO solutions have become popular due to their convenience and cost-efficiency.
- Mobile Messaging Solutions
Mobile messaging (e.g., SMS texting) solutions have gained popularity in recent years due to the ubiquity of cell phones and texting.
Patients can complete ePRO surveys via text messages, making it a convenient and accessible method of data collection. 
The Power of ePRO in Clinical Trials
ePRO systems capture a wide range of measurements that cover a patient’s health status, including physical, mental, and social well-being.
This comprehensive data collection allows researchers to gain insights into non-clinical factors that impact patient outcomes, such as social determinants of health.
By identifying and addressing these factors, healthcare providers can proactively improve patient health and overall outcomes.
Real-time data collection through ePRO has shown promising results in improving patient outcomes.
The Future of ePRO in Clinical Trials
Electronic data collection has become the new norm in clinical settings, and ePRO is rapidly expanding beyond clinical trials.
Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), have recognized the value of ePRO and have implemented app-based data collection systems to inform regulatory decision-making.
ePROs are also being integrated into new models of care, such as Oncology Care First, to improve patient outcomes and ensure high-quality care. 
As technology continues to advance, ePRO software will evolve to meet the changing needs of researchers and patients.
The emphasis on patient-centric care will further drive the adoption of ePRO, as it allows for a better understanding of patient experiences and outcomes.
The utilization of ePRO software in clinical trials has transformed the way patient-reported outcomes are collected and analyzed.
By replacing paper-based methods with electronic solutions, study sponsors and researchers can ensure higher data quality, improved patient compliance, and real-time monitoring of patient outcomes.
As technology continues to advance, ePRO will play an increasingly vital role in shaping the future of clinical research and patient-centered care.
 ePRO vs. Paper
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