Aubrey Llanes

 addressed the first two elements necessary in 

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 comprehension

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.

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

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.”

 To use existing code from within an application to meet specific requirements.

 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:

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 

 (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.

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)

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).

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).

Articles

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

Thoughtful Design in eCOA Development: Part 2

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.

 Further, regulators are encouraging electronic instead of paper-based data collection.

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”

Take advantage of your solution provider’s experience

Rely on configurable platforms not customized solutions

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.

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.

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:

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 

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).

Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient non-compliance with paper diaries. BMJ, 2002;324(7347):1193-1194.

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.

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.

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.

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

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

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

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