To derive the greatest benefits from eCOA technology, several elements must work together to create a strong foundation for sponsor success.
Part 1 of this article addressed the first two elements necessary in thoughtful design (see
Figure 1) to help sponsors derive the greatest benefits from eCOA technology: involving all key stakeholders in the earliest stages of designing and implementing eCOA solutions and carefully considering your data NEEDS versus “nice-to-haves.” Part 2 addresses the next four crucial elements: 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).
Patient-centric design is the most critical factor in eCOA design. Members of the Transcelerate Biopharma’s Patient Technology Initiative spoke with a diverse group of patients to understand what they would like sponsors to consider when designing studies using patient technology. Among those were patient burden, UX, and patient comprehension1 and it is well known within the eCOA industry that best practices should be followed to minimize compromising patients’ comprehension of electronic versions of questionnaires originally developed for paper administration.2,3
One of the easiest ways to ensure simplicity of design is to rely on your solution provider’s previous experience. Typically, they have experience with diverse sponsors, geographic locations, indications, and study parameters. They have spent time extracting lessons learned from post-study discussions with sponsors. Their clinical, scientific, regulatory, project management, and technology expertise is vital in designing and implementing eCOA solutions. Combined with your internal key stakeholders’ project-specific knowledge and their experience with internal processes, systems, and technology, the collaboration will yield a design that makes sense for your study.
Let us first clarify what we mean by “configurable” and “customized.”
Table 1: Configurable versus Customized Software
Consider configurable solutions that allow you to build your study using a standardized library of assessments to meet study goals. For example, the YPrime StudyBuilder solution offers a range of development settings and outputs a study design that is pre-validated and ready for use. Features of YPrime’s StudyBuilder include:
Thoughtful design requires us to consider the burden this technology may place on patients and sites. It is important that sponsors and solution providers remember to stick to the basics and keep simple the UX design. Some factors to consider:
By investing time and resources upfront on thoughtful design (see Figure 1), sponsors can streamline and gain efficiencies during the study development process, reduce time to first-patient-in, increase site satisfaction, and ensure patient compliance.
Aubrey Llanes is a Product Director, eCOA at YPrime