Thoughtful Design in eCOA Development: Part 2

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).

Best practices in design

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

• Uncomplicated design is crucial in ensuring:
• All information can be understood by all end users (sites and patients)
• Simplicity of use regardless of technical literacy
• Effective use of the end-user’s time
• UX is overall positive

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.

Configurable platform vs. customized solutions

Let us first clarify what we mean by “configurable” and “customized.”

• Configurable: To use existing code from within an application to meet specific requirements.
• Customized: To write new software code to meet specific requirements.
• In Table 1, we describe the benefits of the configurable platform and potential challenges of customized solutions.

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:

• Questionnaire creation wizard
• Control selectors and input management
• Visit designer
• Business rule generator
• Translation management grid
• DCF workflow builder

Focus on user experience

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:

• Amount of time the patient must invest to set up, use, close out, and return the device
• Keeping it simple with easy-to-understand user guides, login screen, and other navigation
• Amount of disruption to the patient’s daily activities
• Level of comfort as patients wear or carry the device throughout their day
• Direct patient interaction versus passive data collection and transmission

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

References

1. TransCelerate Bio Pharma Inc. Patient Considerations: A patient perspective on key considerations for sponsors implementing patient technology in clinical trials. Available from: https://transceleratebiopharmainc.com/patient-technology-implementation-framework/patient-technology-assets/. (Accessed April 19, 2021)
2. 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).
3. 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).