TORONTO, ON--(Marketwired - October 28, 2016) - A panel of speakers from ICON including Magdi Vanya (Lead Outcomes Researcher), Olga Moshkovich (Outcomes Researcher) and Katy Benjamin (Principal) will discuss the methodology for developing and validating Clinician-Reported Outcomes (ClinROs) for implementation in clinical trials and to support labeling claims. The live event will take place on Wednesday, November 16, 2016 at 11am EST (4pm GMT/UK).
In the broader family of Clinical Outcomes Assessments (COAs), ClinROs are appropriate for outcomes which cannot be reported by a patient, and are observable but require judgment or interpretation by a trained health professional. As there are no regulatory guidelines specific to ClinROs, the speakers will share how they apply the Patient Reported Outcome guidance (FDA/SEALD Guidance for Industry 2009) as a framework for ClinRO development and validation.
The panel will share two recent case examples to illustrate the challenges in developing and validating ClinROs and share lessons learned in the development of a novel ClinRO intended to measure functional status of extremely premature infants in intensive care, and in the validation of a ClinRO following the completion of the clinical trial, where the ClinRO was included as a secondary endpoint to assess joint arthropathy in adult hemophilia patients
With the first case example, ICON will focus on the methodology leading to instrument development, including a targeted literature review, expert interviews, a Delphi panel, cognitive interviewing, and an online physician survey. In the second example, the speakers will describe the design of a hybrid study to evaluate both the reliability and content validity of an already-developed ClinRO that was adapted from a pediatric measure for the adult patient population. Psychometric validity was also supported by analyses conducted with the trial dataset.
- 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?
To learn more about this event visit: Development and Validation of Clinician-Reported Outcomes Measures (ClinROs): Review of Best Practices and Lessons Learned
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