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Patient Reported Outcomes
Session Chair(s)
Darryl L'Heureux, PhD, MPharm, MSc
Director, Clinical Science, Medical Writing, and Publications
Ambrx, Inc, United States
Patient Reported Outcomes (PRO) involve the measurement of an aspect of a patient's health status based on information that is gathered directly from the patient, without interpretation by physicians or others. Patients provide information concerning the impact of an intervention or therapy from their perspective. This session will cover the design and selection of PRO assessments or measurements within the regulatory framework and also from a PRO consortium’s perspective; it will also touch on a non-profit organization’s perspective of PRO.
Learning Objective : -Explain the design of PRO assessment tools and appropriate selection and use of such tools -Discuss advantages and disadvantages of working collaboratively within a pre-competitive consortium to develop and qualify PRO instruments for use in clinical trials where PRO endpoints are used to support product labeling claims - Describe why electronic capture of PRO endpoint data in clinical trials is receiving increasing attention
Speaker(s)
Faculty
Darryl L'Heureux, PhD, MPharm, MSc
Ambrx, Inc, United States
Director, Clinical Science, Medical Writing, and Publications
Faculty
Stephen Joel Coons, PhD
Critical Path Institute, United States
Senior Advisor
Faculty
J. Jason Lundy, PhD
Outcometrix, United States
Principal
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