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“Utilizing ePROs not only facilitates better data collection but also contributes to improved quality of care and patient safety”. “FIdec achieved over 98% patient adherence using the proper ePRO”
ePRO stands for electronic Patient Reported Outcomes. This system allows patients to report their health status, symptoms, and quality of life using digital tools, such as smartphones or computers.
To provide context, we reference the paper Implementation and impact of an electronic patient-reported outcomes system in a phase II multi-site adaptive platform clinical trial for early-stage breast cancer, which details the development and implementation of a system for monitoring patient-reported adverse events and quality of life through ePRO.
The paper highlights the importance of ePRO instruments in clinical trials, emphasizing their role in capturing patient experiences and outcomes, which can improve patient care and safety. By integrating technology in data collection, ePROs enhance the accuracy and efficiency of clinical trial data.
One primary challenge discussed in the paper is historically low completion rates of patient-reported questionnaires. However, the paper concludes that using ePROs not only improves data collection but also enhances the quality of care and patient safety. By capturing real-time patient experiences and adverse events, healthcare providers can better respond to patient needs throughout the trial.
Let’s explore the benefits of PROs and ways to overcome these challenges.
The Benefits of Patient-Reported Outcomes
ePROs offer several key advantages in clinical research:
- Convenience: When using an Electronic Patient Reported Outcome Patients can complete surveys from home, making it more likely they will participate. Participants fill out directly symptoms at the EDC, Electronic Data Capture.
- Improved Accuracy: Digital forms can reduce errors that might happen with paper surveys, leading to more reliable data collection.
- Better patient engagement: When patients are actively involved in tracking their symptoms and progress, they feel more connected to the study, often leading to higher retention and adherence to protocols.
- Higher data quality: Real-time data entry directly from patients reduces the risk of errors that come from manual transcription, ensuring more reliable results.
- Faster drug development: Efficient data collection can speed up decision-making, helping bring new treatments to market more quickly.
Selecting the Right Electronic Patient-Reported Outcomes
When selecting ePRO measures for a trial, it’s essential to consider technological barriers, especially in rural or economically disadvantaged areas. Ensuring ePRO tools are accessible and easy to use can significantly impact the success of a trial, making the choice of ePROs crucial for improving patient participation and overall trial outcomes.
TrialPal was developed to facilitate clinical trial implementation and enhance patient usability. One of the keys benefits our clients highlight is the provision of electronic devices, recognizing the reality for many participants—particularly in Latin America—who may live in areas with limited internet coverage.
Additionally, TrialPal’s agility in implementation, flexibility in symptom inclusion, dependencies, cohorts, and real-time reporting for researchers makes it an ideal ally for both participants and clinical researchers.
What’s the Best Patient-Reported Outcomes Software?
The complete solution that addresses the challenges of collecting ePROs is TrialPal’s eCOA and ePRO platform. It’s designed with the specific needs of clinical researchers in mind, offering features that simplify the process.
Those are its main features:
- Intuitive user interface: TrialPal’s intuitive interface is easy to navigate, even for users with limited technical skills. Its offline mode allows patients to continue reporting data even without internet access. Patient-Reported Outcome app has a traveler mode, you can go anywhere worldwide and keep reporting the days you are out of your time zone.
- Multilingual support: We offer support for multiple languages, making it ideal for global clinical trials. TrialPal supports multiple languages, making it suitable for global clinical trials. Customization options ensure that the software can meet the specific linguistic needs of each study.
- Regulatory compliance: TrialPal adheres to stringent regulatory requirements, including 21 CFR Part 11 and GCP guidelines. Our Patient reported outcome solution is designed to meet the rigorous standards of regulatory agencies worldwide, including the FDA, EMA, and other regulatory bodies. The system is fully compliant with 21 CFR Part 11 and GCP guidelines, ensuring data integrity and auditability.
- Data security and privacy: With stringent security protocols, including HIPAA compliance, the platform ensures that patient data remains confidential and protected.
- Customization: Whether you need simple surveys or more complex assessments, TrialPal’s platform can be tailored to fit the specific requirements of any trial.
- Integration capabilities: TrialPal easily connects with other clinical systems like EDC, EMR, and CTMS, ensuring smooth data exchange.
- Scalability: The platform is built to handle everything from small studies to large-scale international trials.
- Multichannel: A setup tool to easily and quickly create eDiaries, forms, and more. It includes eDiary assessments, adaptable rules, and a UX tailored to different patient groups ( eldery people)—such as larger fonts, ample spacing, accessible colors, and intuitive buttons for older adults.
How Does a Patient Reported Outcome Work?
In vaccine trials, ePROs provide critical insights into how patients respond to treatments over time. One of our clients achieved over 98% patient adherence using TrialPal’s PRO platform. By leveraging robust notification systems and delivering educational content in the patient’s native language, they significantly improved the overall quality and consistency of the data collected.
Watch the following video to find out more results.
Conclusion
In the referenced study, a key benefit of ePRO systems was the increased patient engagement in clinical trials. Patients who completed initial questionnaires were more likely to continue participating in subsequent surveys. This engagement is crucial for gathering comprehensive trial data. By capturing patient-reported outcomes electronically, healthcare providers gain valuable insights into treatment impacts on patient quality of life.
TrialPal understands the diverse requirements of vaccine clinical trials, from basic to advanced needs. Our ePRO solution addresses these challenges with a secure, user-friendly platform that integrates seamlessly with existing clinical systems and provides offline functionality for patients in remote areas. By enhancing accessibility and data accuracy in PROs, we improve the quality of clinical trials and ultimately, patient care.
References
Anna, Northrop., Anika, Christofferson., S., Umashankar., Michelle, E., Melisko., Paolo, Castillo., Diane, Heditsian., S., Brain., C., Simmons., T.J., Hieken., Kathryn, J, Ruddy., C., Mainor., Anosheh, Afghahi., S., Tevis., Anne, Blaes., Irene, M., Kang., Adam, Asare., L., Esserman., D.L., Hershman., Amrita, Basu. (2024). Implementation and impact of an electronic patient reported outcomes system in a phase II multi-site adaptive platform clinical trial for early-stage breast cancer.. Journal of the American Medical Informatics Association. https://academic.oup.com/jamia/advance-article-abstract/doi/10.1093/jamia/ocae190/7735831?redirectedFrom=fulltext
