Measurement in Clinical Trials: An Examination of the FDA Position on the Review of Clinical Outcome Assessments (COAs)
Sep 12 2013 11:00AM - Sep 12 2013 12:00PM | Online
This Solution Provider Webinar is brought to you by DIA in cooperation with ICON plc. Registration for Solution Provider Webinars are FREE! Sign up by clicking on the Register Online button.
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 are not available for this event.
- 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.
Registration for Solution Provider Webinars are FREE! Sign up by clicking on the Register Online button.
Click here for minimum system requirements.
There are no Group Discounts for this event.
DIA reserves the right to modify or cancel programs and/or substiture presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond it's control.
Participants with Disabilites: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to the event to indicate your needs.
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.