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Towards a Patient-Focused Drug Development Ecosystem: Adoption of Core Outcome Sets
Session Chair(s)
Samantha Roberts, PHD
Senior Director, Regulatory Intelligence, AstraZeneca, United States
This forum will explore efforts by regulators and the patient community to develop core outcome sets within specific diseases. Panelists will discuss how these can be leveraged to support drug development programs and facilitate shared learnings.
Learning Objective : Describe the rationale for and existing efforts to develop core outcome sets; Describe how adoption of core outcome sets facilitates patient-focused drug development; Propose a mechanism to facilitate shared learnings across stakeholders to advance adoption of core sets.
Speaker(s)
Allison Martin, MS
Director, Faegre Drinker Consulting, United States
Measuring What Matters Most: AD PACE
Robyn Bent, BSN, MS, RN
Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
FDA CDER Standard Core Sets Pilot Program
Eleanor M. Perfetto, PHD, MS
Independent Consultant, Consultant, United States
Patient-Centered Core Impact Sets
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