ClinROs are appropriate for outcomes that cannot be reported by a patient, and are observable but require interpretation by a trained health professional
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.
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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 include:
- 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?
Lead Outcomes Researcher, ICON
Magdi oversees the development, selection, and validation of outcomes instruments from concept elicitation through psychometric validation, as well as preparing FDA evidence dossiers. She has expertise in autoimmune disease, hematology, rare diseases, neurology, and renal disease, with specific focus on defining and measuring the concept of fatigue across different therapeutic conditions. Prior to joining the ICON COA team in 2011, Magdi worked on a NIH-funded multi-method project in the field of substance use and violence prevention. She has over 20 years of qualitative research and project management experience. Magdi completed her PhD in Sociology at the University of California, Davis.
Outcomes Researcher, ICON
Olga has been with ICON’s COA group for three years. In her role, Olga is responsible for managing studies to support the development and validation of COAs. Prior to joining ICON, Olga conducted epidemiological research at an academic center specializing in youth health and development. Olga is experienced in the design and implementation of qualitative research, survey design, and qualitative interviewing and analysis. Her research experience has spanned various disease areas including lupus, lung cancer, hemophilia, sickle cell, substance use, and health care quality improvement. Olga earned her BA degree in biology from Cornell University, and her Master’s in Public Health degree in epidemiology from University of Maryland.
This program is intended for COA scientists and those with interest in COAs, including senior level decision makers in:
- Late Phase Research
- Project Management
- Patient Registries
- Risk Management
- Market Access
- Regulatory Affairs