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Wednesday, June 22 • 4:15pm - 5:15pm
#366: Development of Standard Core Sets of Clinical Outcome Assessments and Related Endpoints

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-634-L04-P ; CME 1.00; RN 1.00

This session will provide an opportunity for key stakeholders, including regulators, product developers, instrument developers, and patients to discuss various experiences with the development of the core sets.

Learning Objectives

Describe FDA’s efforts to support the development of core sets of clinical outcome assessments; Outline the benefits of core outcome sets; Discuss learnings from the FDA’s grant program.

Chair

Robyn Bent, MS, RN

Speaker

Moderator
Ebony Dashiell-Aje, PhD

Industry Update
R.J. Wirth, PhD

Industry Update
Elizabeth Nicki Bush, MHS

FDA Update
Michelle Campbell, PhD



Speakers
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development Program, OCD, CDER, FDA, United States
Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn was... Read More →
avatar for Elizabeth (Nicki)  Bush

Elizabeth (Nicki) Bush

Associate VP and Head, Patient-Focused Endpoints and Measurement, Eli Lilly and Company, United States
Elizabeth (Nicki) Bush is Associate Vice President and Head of Patient-Focused Endpoints and Measurement at Eli Lilly and Company, responsible for the design and implementation of patient-centered measurement strategies to support drug development efforts across Lilly’s portfolio... Read More →
avatar for Michelle Campbell

Michelle Campbell

Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER, FDA, United States
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a reviewer... Read More →
avatar for R.J. Wirth

R.J. Wirth

CEO, Vector Psychometric Group, LLC, United States
R.J. Wirth is Chief Executive Officer, co-Founder, and a managing partner at VPG. Dr. Wirth received his PhD in quantitative psychology / psychometrics from the historic LL Thurstone Psychometric Laboratory at University of North Carolina – Chapel Hill. For nearly two decades, Dr... Read More →


Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session