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Measurement in Clinical Trials: An Examination of the FDA Position on Review of Clinical Outcome Assessments (COAs)

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Overview 

This Solution Provider Archived Webinar is brought to you by DIA in cooperation with ICON plc. Registration for Solution Provider Archived 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 and Certificate Program Units are not available for this event.

This archived webinar will be available through September 30, 2014.

Featured Topics 

  • 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

Learning Objectives 

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.

Special Offers 

Registration for Solution Provider Archived Webinars are FREE! Sign up by clicking on the Register Online button.

Contact Information 

Questions on Archived Webinar
Jessica Culp
DIA North America
Phone +1.215.442.6132
Fax +1.215.442.6199
Jessica.Culp@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Friday, September 13, 2013

  • 7:00AM - 11:59PM

    Measurement in Clinical Trials: An Examination of the FDA Position on Review of Clinical Outcome Assessments (COAs)

    Speaker(s):

    • FDA Classification of COAs and Evidence Requirements
      Emuella Flood
      Director, Patient-Reported Outcomes
      ICON Late Phase and Outcomes Research, United States
    • Challenges and Experiences of Evaluating Non-PRO COAs to PRO Standards
      Cicely Kerr, PhD,MSc
      Lead Outcomes Researcher, Patient Reported Outcomes
      ICON plc , United Kingdom
    • Industry Perspective on the FDA position on Review of COAs
      April N. Naegeli, DrPH,MPH
      Senior Research Scientist, Global Patient Outcomes and Real World Evidence
      Eli Lilly and Company, United States

Registration Fees 

Other Fees

Standard
$0.00
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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.

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