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Clinical Outcome Assessments (COAs) include Patient Reported Outcomes (PROs), Observer Reported Outcomes (ObsROs) and Clinician Reported Outcomes (ClinROs) and are used to evaluate treatment benefit. In 2009, after a period of consultation, the FDA published guidance on the level of evidence required for PRO endpoints. In 2011 the FDA announced that ObsROs and ClinROs will be held to the same levels of evidence requirements as PRO endpoints, although guidance specific to other types of COAs has not been issued.
This webinar will address challenges, experiences and best measures of evaluating non-PRO COAs to PRO standards and provide an industry perspective on the FDA position on review of COAs.
Continuing Education Credits and Certificate Program Units are not available for this event.
This archived webinar will be available through January 31, 2016.
- Classifications and definitions of COAs
- FDA evidence requirements for PROs
- Challenges and experiences of evaluating non-PRO COAs to PRO standards
- ISPOR ClinROs Good Measurement Practices Task Force
- Industry perspective on the FDA position on review of COAs
Who should attend?
Professionals who work in the area of:
- Medical product development
- Outcomes Research
- Regulatory affairs
At the conclusion of this webinar, participants should be able to:
- Define and recognize the different types of COAs
- Identify the regulatory evidence requirements for PROs
- Demonstrate awareness of the challenges associated with application of these requirements to other COAs
- Plan for development of evidence for COAs used in medical product development to meet FDA requirements
- Identify new guidance and resources as they become available.