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W-13: Best Practices for the Electronic Migration and Implementation of Clinician-Reported Outcomes Assessments in Clinical Trials

Poster Presenter

Heather Romero

Clinical Scientist
WCG – Analgesic Solutions
United States

Objectives

Best practices for electronic migration of clinical outcome assessments (COAs) have mostly focused on patient-reported outcome (PRO) measures. While some migration best practices are shared, clinician-reported outcome (ClinRO) assessments, require best practices that address their unique challenges.

Method

The Critical Path Institute’s Electronic Patient-Reported Outcome (ePRO) Consortium and PRO Consortium developed consensus-defined best practice recommendations for electronic migration and implementation of ClinRO assessments in clinical trials based on industry standards and relevant literature.

Results

When migrated properly, electronic ClinRO (eClinRO) assessments can ensure data comparability by keeping the instrument standardized and consistent with its original intent and meaning (i.e., the original validated reference instrument that is typically on paper). The electronic migration process starts with obtaining the validated reference from the author/publisher. The goal of this process is a faithful migration, such that the clinician completing the ClinRO assessment interprets items the same way regardless of mode of data collection or level of complexity. ClinRO assessments can be categorized as having low complexity or high complexity, depending on the number of elements that need to be programmed electronically (e.g., branching logic, validation checks of score values, or score conversions). The consensus panel proposed that expert review/user testing by a clinician (who has experience with the instrument being migrated) and author/license holder review of screenshots (if possible) would be sufficient to support minimal modifications during migration. Additional evidence was proposed for eClinRO assessment modifications that deviate significantly from the validated reference. The implementation of an eClinRO assessment in clinical trials involves four phases in the run up to first patient screening date, including planning, start-up, eCOA solution development, and deployment to the live production environment. Concurrent with migration and implementation activities is the development of training materials that prepare the qualified investigators to administer the eClinRO assessment, including training on the ClinRO assessment, and training on the electronic device. The consensus panel provided best practices recommendations for coordinated implementation and training to optimize the benefits of eClinRO assessments in the clinical trial setting.

Conclusion

The proposed best practice recommendations for eCOA vendors and clinical trial sponsors will support high quality electronic migration and implementation of ClinRO assessments in clinical trials. Recent literature shows that PRO measures routinely provide comparable data when migrated from paper to electronic modes faithfully. Electronic administration of ClinRO assessments also bring advantages to clinical trials, such as direct data capture and reduced missing data. In addition, since ClinRO assessments are administered by qualified clinical investigators, eClinRO assessments reinforce standardized administration across multiple sites and improve interrater reliability and data quality overall. Two key aspects of electronic migration and implementation are 1) obtaining and adhering to the validated reference and 2) including expert clinician review throughout the development process. Criterion to judge complexity of a ClinRO assessment (e.g., low vs. high complexity) can assist industry stakeholders in planning for the development of the eClinRO assessment solution, with the goal of ensuring that faithful migration is achieved. Evidence to support successful migration is minimal for eClinRO assessments that have been faithfully migrated, while additional evidence is needed for eClinRO assessments that deviate significantly from the validated reference. Steps for implementing the eClinRO assessment solution can provide a common framework for industry partners to support planning and coordination of start-up activities. Utilizing these best practices will improve the precision of ClinRO data collected in clinical trials to support product registration. Co-authors: Sonya Eremenco, Kathy Wyrwich, Paul O’Donohoe, Dan DeBonis, Valdo Arnera, Shelly Steele, Tom Willgoss, Kristina Harris, Cindy Howry, Mabel Crescioni and Jill Platko