Patrick spoke at ISPOR in a session about emerging good pratices in COAs.
CLINICAL OUTCOME ASSESSMENTS (COAS): A CONCEPTUAL FOUNDATION AND DEVELOPING AND EVALUATING CLINICIAN-REPORTED OUTCOME (CLINRO) INSTRUMENTS TO ASSESS TREATMENT BENEFIT: EMERGING GOOD PRACTICES
John H. Powers, MD, FACP, FIDSA, Associate Clinical Professor of Medicine, George Washington University School of Medicine, Washington, DC, USA
- Laurie B. Burke, RPh, MPH, Founder, Lora Group, LLC, Royal Oak, MD, USA and Former Director, Study Endpoints and Labeling Development, ONDIO, CDER, U.S. Food & Drug Administration, Silver Spring, MD, USA
- Donald Patrick, PhD, MSPH, Professor, Department of Health Services & Director, Seattle Quality of Life Group & Biobehavioral Cancer Training Program, University of Washington, Seattle, WA, USA
- Stefan Cano, PhD, CPsychol, AFBPsS, Co-Founder and Chief Science Officer, Modus Outcomes LLC, Stotfold, UK
- Patrick Marquis, MD, MBA, CEO, Modus Outcomes LLC, Newton, MA, USA
There is an urgent need for a standardized conceptual foundation for clinical outcome assessments (COAs) – ClinRO, ObsRO, PRO, or PerfO measures. The differences in each type of instrument dictate different approaches for development and evaluation. The Task Force undertook guidelines for ClinRO instruments. Task Force members will open discussion by defining what should be considered a ClinRO measure and providing a framework to describe these types of measures. They will present US (FDA) and European Medicines Agency (EMA) regulatory perspectives as well as their final recommendations on evaluation of ClinRO instruments for use to document treatment benefit. Identification of the treatment benefit and endpoint based on a ClinRO score, the concept of interest that is measured and context of use, evaluation of the instrument’s measurement properties will be included. Guidelines for interpretation and implementation in clinical trials conclude the discussion. The findings of these two Task Force reports will be very beneficial to those involved in evaluating treatment benefit using any type of COA. Presented by the ISPOR Clinical Outcomes Assessment – Emerging Good Practices Task Force