Clinician-reported outcomes (ClinROs) are needed for the systematic evaluation of new central nervous system and other medical products. Although there is guidance from the FDA and other regulatory agencies on the development of patient-reported outcomes (PROs), there is less information on agency requirements for new ClinROs. Many of the development approaches for PROs may not be applicable for ClinROs. This webinar will focus on scientific and practical considerations for the development and psychometric evaluation of new clinician-reported outcomes for application in clinical development programs. Clinical rater training and certification is critical for successful ClinROs. Critical considerations from scientific and practical viewpoints will be presented, and examples from completed instrument development projects will be presented.
Who Should Attend
Those involved in decision making in the following areas:
- Health Outcomes
- Outcomes Research
- Data Analysis
- Health Policy
- Clinical Development
- Medical Affairs
- Value Development
- Evidence Generation
Key Learning Objectives
- Understand the differences between patient-reported outcomes and clinician-reported outcomes.
- Understand the key stages in the development of clinician-reported outcomes.
- Understand the scientific and practical issues associated with development and psychometric evaluation of clinician-reported outcomes.
- Understand scientific and practical issues associated with rater training and qualification of clinician-reported outcomes.
Dennis Revicki, Senior Vice President, Outcomes Research, Evidera
Leah Kleinman, Senior Director, Scientific Solutions, Evidera
William Lenderking, Senior Research Leader, Evidera