eCOA: Should Sponsors Give Clinical Sites More Control?

Electronic Clinical Outcome Assessments (eCOA) have significantly advanced clinical trials, offering a more accurate and efficient data collection method. However, the traditional model requiring sponsor or CRO approval for data changes is increasingly seen as an impediment to real-time, accurate data capture. A recent publication in the Journal of the Society for Clinical Data Management (JSCDM) highlights the emerging trend of empowering clinical sites with more control in eCOA data management. It specifically advocates for allowing sites the capability to unlock eCOA forms for patients independently, a move aimed at enhancing the quality of data collected in clinical trials. This article explores the compelling arguments for granting clinical sites the autonomy to modify eCOA data without requiring sponsor approval to maintain data integrity and provides recommendations on enhancing eCOA oversight in this type of environment.

The Importance of Autonomy for Clinical Sites in eCOA Data Management

The precision of electronic patient-reported outcomes (ePROs) is paramount in clinical trials, and in a perfect world, all data is reported accurately. However, the reality often presents challenges, as highlighted by a study on adverse event reporting in clinical trials.

The study showed that patient experience and perception significantly influence reporting symptoms and adverse events. It also demonstrated the complexity of accurate reporting and the challenges hospital-based staff face in interpreting patient-reported data. This variability can lead to inconsistencies in how patients report symptoms compared to how clinical staff interpret these reports, impacting ePRO data quality. This disparity emphasizes the need for a more adaptable and responsive eCOA data management system, where eCOA modifications can be triggered by site staff when discrepancies are identified.

To address these challenges, clinical sites and patients should be able to modify eCOA forms after submission. This would allow for quick corrections or updates by patients or staff, responding to the variable nature of patient-reported symptoms. Eliminating the need for sponsor approval for each change would make the process more efficient and ensure accurate data collection. Granting clinical sites the autonomy to unlock eCOA forms offers several benefits to sponsors:

• Real-time Data Accuracy: Clinical sites can promptly unlock eCOA data to allow patients to reflect changes in their condition more accurately or provide proper context if there was a misunderstanding, ensuring the data is current and accurate.
• Reduction of Bias: Allowing clinical sites to change data without sponsor approval reduces the potential for bias. For example, a sponsor might reject a data change that could negatively impact trial outcomes, but the site’s autonomy ensures unbiased reporting.
• Ethical Data Management: This approach respects patient experiences and contributes to ethical trial conduct. Patients will take the trial more seriously if they can accurately report their data after realizing they made a mistake, encouraging precision in data reporting.

“The beauty of the Medable eCOA Plus platform is that it provides empirical data directly collected from the patient, including subjective and objective responses that can be then analyzed, and data insights can be drawn centrally in real-time,” said Colin Weller, VP, and General Manager for Digital Outcomes at Medable.

If Sites Can Unlock eCOA for Patients, Better Oversight is Required

In scenarios where clinical sites can unlock eCOAs, there’s a heightened need for robust oversight mechanisms to mitigate the risks of inaccurate or unethical data manipulation. Data inconsistencies, non-compliance with regulatory standards, and potential biases can significantly impact trial outcomes and patient safety without adequate oversight. To address these challenges, sponsors can implement several strategies:

• Robust Audit Trails: Select eCOA systems to meticulously track each change made to the eCOA data, capturing details of the person making the change, the timing, and the specific reasons for the change, per regulatory guidelines.
• Data Monitoring Systems: Employ advanced tools to review eCOA data continuously, ensuring changes are consistent with patient profiles and clinical expectations.
• Regular Data Reviews and Reconciliation: Conduct systematic reviews of eCOA data to identify discrepancies and involve clinical site staff to understand the context of changes.
• Training and Guidelines for Clinical Sites: Offer comprehensive training and clear guidelines to clinical site staff for unlocking eCOA forms and allowing patients to change their data.

These measures ensure that while clinical sites can respond swiftly to the need for data changes, there remains a structured and transparent oversight process to maintain the trial’s integrity.

Key Features of Effective eCOA Systems

With evolving data management approaches in clinical trials, there’s an increasing need for eCOA systems equipped for enhanced sponsor oversight. As clinical sites gain more autonomy in data handling, it becomes crucial to have systems that can effectively monitor, track, and validate data changes. This ensures that data integrity is maintained while adhering to regulatory standards, and sponsors can efficiently oversee trial processes to safeguard against inconsistencies and errors. Key eCOA features could include:

• Comprehensive Validated Instruments: A wide range of pre-built, scientifically reviewed, and validated scales to accurately measure patient outcomes across various conditions – this reduces patient confusion and improves data accuracy by using tried and tested Electronic Clinical Outcome Assessments instruments.
• Integration with Digital Monitoring Tools: Capability to include data from wearables and sensors, providing a more holistic and accurate view of the patient’s health.
• User-Friendly Interface: An intuitive design for patients and clinical staff to ensure ease of use and accurate data entry.
• Real-Time Data Management: Systems allowing sites to unlock Electronic Clinical Outcome Assessment immediately forms for patient updates and corrections, enhancing data accuracy and timeliness.
• Robust Audit Trails and Data Security: Advanced tracking of all data changes with solid security measures to protect patient information and comply with regulatory standards.
• AI and Automation: Utilizing artificial intelligence and intelligent automation for efficient study setup and data management.
• Unified Platform: A single platform for various trial needs, ensuring standardized data collection and structure.

“Our library of pre-validated scales has undergone a comprehensive scientific review, follows industry best practices, has been reviewed and pre-validated by authors, and is ready for clinical trial deployment. Additionally, our platform goes beyond just eCOA; it includes digital physiological measures collected from sensors and wearables directly from the patients. This platform allows for a much truer and more granular picture of the patient experience within the clinical trial,” added Weller.

Summary

It is vital to grant clinical sites the autonomy to update Electronic Clinical Outcome Assessments data to enhance accuracy and ethical data management. Utilizing the approach advocates for robust oversight mechanisms, such as audit trails and data monitoring systems, to ensure data integrity and compliance with regulatory standards. Essential eCOA system features, including validated instruments and real-time data management, address the evolving needs of both sites and patients. These advancements are crucial for maintaining the efficacy and reliability of clinical trials in the modern research environment.

References

[1] Delong, P. S. & Humler, D. & Haag, T. & Yeomans, A. & Andrus, J. & Eremenco, S. & Finan, A. & Gable, J. & Gilfillan, D. & Howry, C. & Kern, S. & Lesniewski, S. & Simpliciano, K. & Staunton, H. & Turnbull, J. & Workman, C. & Raymond, S., (2023) “Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes”, Journal of the Society for Clinical Data Management 1. doi: https://doi.org/10.47912/jscdm.249

[2] Kennedy F, Shearsmith L, Ayres M, et al. Online monitoring of patient self-reported adverse events in early phase clinical trials: Views from patients, clinicians, and trial staff. Clinical Trials. 2021;18(2):168-179. doi:10.1177/1740774520972125

This article is sponsored by Medable.