Thoughtful Design in eCOA Development: Part 1

Industry has learned through experience that electronic technology to collect clinical outcome assessments (eCOAs) can enhance the patient experience, increase site satisfaction, facilitate regulatory compliance, gather more reliable data, and save time in the process.^1,2,3 Further, regulators are encouraging electronic instead of paper-based data collection.^4,5,6

To derive the greatest benefits from this technology, several crucial elements must work together to create a strong foundation for sponsor success:

• Involve all key stakeholders in the early stages
• Carefully consider data NEEDS versus “nice-to-haves”
• Implement best practices in design^7,8
• Take advantage of your solution provider’s experience

• Rely on configurable platforms not customized solutions
• Focus on user experience (UX)

The first two elements will be addressed in this article and the last four elements in Thoughtful Design in eCOA Development: Part 2.

Involve all key stakeholders from the start

It cannot be emphasized enough how important it is to include all your key stakeholders in the earliest stages of designing and implementing eCOA solutions for a clinical trial. This includes, but may not be limited to, your solution provider, study team, medical advisors, data management, and biostatistics. From the start, it is important for your stakeholders to collaborate and come to agreement on how eCOA technology will be used to achieve protocol objectives. This stakeholder engagement ensures everyone is clear about the scope, measurement modalities, the eCOA data being collected, start and end timelines, milestones, and how to minimize risks.

Risks to not collaborating early

• Team members who join the development team late in the process may attempt to change functionality or design after timelines and budgets are set, creating disagreements and delays through the design, development, and validation process.
• Last minute changes during user acceptance testing (UAT) can negatively impact the timeline because of revised scope and increase the costs.
• These changes can also increase risk as they were not incorporated into initial design and testing scenarios.

Benefits of early and inclusive collaboration

• The team can make design and implementation decisions based on collective knowledge and experience to create a better user experience for patients, sites, and sponsors.
• Ensures stakeholders are aware of key decisions and how those decisions will impact the study throughout its lifecycle.
• Ensures the eCOA technology, data collection specifications, data transfer requirements, and data reconciliation processes can be supported by your organization’s procedures, systems, and data collection platforms.

Although it may take more time and resources at the start of the study to work collaboratively with all the stakeholders, the benefits of a well-defined and reliable eCOA solution may far outweigh that additional time upfront and, ultimately, save you time and resources throughout the life of that study.

Needs versus ”nice-to-haves”

Just because we CAN capture a specific piece of data through eCOA does not always mean we should. Our natural interest as scientists is to explore as many research questions as possible. The result of this curiosity has led to trials with numerous endpoints, many of which are collected, not as primary or secondary, but rather to answer exploratory questions. Further, the temptation with a convenient technology that presents new ways to interact with sites and patients is to use it to capture as much data as possible for multiple purposes. Instead, we recommend the following:

• Limit endpoints to the most critical
• Collect data at only those necessary timepoints
• Limit the time required for data collection at any given timepoint

Requiring patients to complete lengthy questionnaires at multiple timepoints can be an unreasonable burden and may negatively impact engagement, compliance, and retention. A more successful strategy is to resist the temptation to include too many endpoints and collect only those data needed to answer the most important research questions.

NOTE: Thoughtful Design in eCOA Development: Part 1 addresses two elements necessary in thoughtful design that helps sponsors derive the greatest benefits from eCOA technology. Thoughtful Design in eCOA Development: Part 2 will address implementing best practices in design, taking advantage of your solution provider’s experience, relying on configurable platforms not customized solutions, and focusing on user experience (UX).

Aubrey Llanes is a Product Director, eCOA at YPrime

References

1. Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient non-compliance with paper diaries. BMJ, 2002;324(7347):1193-1194.
2. Shields AL, Shiffman S, Stone A. Patient compliance in an ePRO environment: methods for consistent compliance management, measurement and reporting. In: Byrom B, Tiplady B, eds. ePRO: Electronic Solutions for Patient-Reported Data. Surrey, England: Gower; 2010:127–142.
3. Ganser AL, Raymond SA, Pearson JD. Data Quality and Power in Clinical Trials: A Comparison of ePRO and paper in a randomized clinical trial. In: Byrom B, Tiplady B, eds. ePRO: Electronic Solutions for Patient-Reported Data. Surrey, England: Gower; 2010:49.
4. Coons SJ, Eremenco S, Lundy JJ, O’Donohoe P, O’Gorman H, Malizia W. Capturing patient-reported outcome (PRO) data electronically: the past, present, and promise of ePRO measurement in clinical trials. Patient, 2015;8(4):301-309.
5. U.S. Food and Drug Administration. Guidance for industry—Patient-reported outcome measures: use in medical product development to support labeling claims. December 2009. Available from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims (Accessed April 19, 2021).
6. U.S. Food and Drug Administration. Guidance for industry: electronic source data in clinical investigations. September 2013. Available from www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf (Accessed April 19, 2021).
7. Critical Path Institute ePRO Consortium. Best Practices for Electronic Implementation of Patient-Reported Outcome Response Scale Options. Available from https://c-path.org/wp-content/uploads/2014/05/BestPracticesForElectronicImplementationOfPROResponseScaleOptions.pdf (Accessed April 19, 2021).
8. Critical Path institute ePRO Consortium. Best Practices for Migrating Existing Patient-Reported Outcome Instruments to a New Data Collection Mode. Available from: https://c-path.org//wp-content/uploads/2014/05/BestPracticesForMigratingExistingPROInstrumentstoaNewDataCollectionMode.pdf (Accessed April 19, 2021).