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To derive the greatest benefits from eCOA technology, several elements must work together to create a strong foundation for sponsor success.
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:
The first two elements will be addressed in this article and the last four elements in Thoughtful Design in eCOA Development: Part 2.
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
Benefits of early and inclusive collaboration
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.
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:
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