Development and Validation of Clinician-Reported Outcomes Measures (ClinROs)

Presented by

Magdi Vanya, Lead Outcomes Researcher, ICON

About this talk

In the broader family of Clinical Outcomes Assessments (COAs), ClinROs are appropriate for outcomes that cannot be reported by a patient, and are observable but require judgment or interpretation by a trained health professional. This webinar will focus on the methodology for developing and validating Clinician-Reported Outcomes (ClinROs) for implementation in clinical trials and to support labeling claims. As there are no regulatory guidelines specific to ClinROs, we will share how we apply the Patient Reported Outcome guidance (FDA/SEALD Guidance for Industry 2009) as a framework for ClinRO development and validation. Key insights: Using two recent case examples we will illustrate the challenges in developing and validating ClinROs and share lessons learned in the development of a novel ClinRO. Attendees will learn: - What is a ClinRO, and when is it appropriate to use one over other types of COAs? - What are best practices for developing and validating ClinROs? - What are some of the key challenges and potential solutions in ClinRO development and validation? - What are some of the key considerations for implementing ClinROs in a clinical study? Speakers: Magdi Vanya, Lead Outcomes Researcher, ICON; Olga Moshkovich, Outcomes Researcher, ICON; Katy Benjamin, Principal, ICON.

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