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Wednesday, June 21 • 4:00pm - 5:15pm
#382: Patient-Relevant, Fit-For-Purpose Endpoints: If You Can Believe It, You Can Achieve It

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Patient-focused clinical outcome assessments (COAs) are necessary for ensuring that the patient perspective is sufficiently incorporated into drug development decision-making. This session will cover regulatory, industry and instrument developer perspectives on how to efficiently and successfully design and implement patient-focused COAs as endpoints that are fit-for-purpose in drug development. FDA participant(s) will provide perspective on: 1) current initiatives (e.g., the COA Compendium, Critical Path Innovation Meetings, qualification partnerships, etc.) that can help facilitate the development and use of patient-focused COAs as endpoints in clinical trials; 2) best practices for interacting with the FDA; and 3) methods for engaging patients in COA endpoint development. An industry representative will offer perspective on recent patient-focused cultural shifts in industry and their impact on COA development and implementation in clinical trials. An Instrument developer will also discuss practical experiences in designing patient-focused COAs for use as endpoints in clinical trials.

Learning Objectives

Describe the best practices for successfully developing and implementing patient-focused COA study endpoints that are fit-for-purpose for use in clinical trials.

Chair

Elektra Johanna Papadopoulos, MD, MPH

Speaker

Best Practices for Facilitating the Development and Use of Patient-Focused, Fit-For-Purpose COA Endpoints in Clinical Trials
Ebony N. Dashiell-Aje, PhD

Industry Initiatives: Cultural Shifts Impacting COA Development and Implementation in Clinical Trials
Lisa A. Kammerman, PhD, MS

Practical Experiences in Designing Patient-Focused COAs for Use as Endpoints in Clinical Trials: An Instrument Developer’s Perspective
Chad Gwaltney, PhD


Speakers
avatar for Ebony Dashiell-Aje

Ebony Dashiell-Aje

Director, Regulatory Outcomes Research, BioMarin
Dr. Dashiell-Aje is a leading expert in clinical outcome assessment (COA) design and implementation, advising on COAs, study endpoint issues and regulatory science. As a health outcomes researcher and methodologist, Dr. Dashiell-Aje is driven by her passion for public health and promoting... Read More →
avatar for Chad Gwaltney

Chad Gwaltney

Principal Consultant, Gwaltney Consulting
Dr. Gwaltney’s work focuses on the development of innovative methods to measure patient-centered outcomes in clinical trials. He has published numerous articles and book chapters addressing how the patient’s perspective can be examined to better understand product efficacy and... Read More →
LK

Lisa Kammerman

Senior Statistical Science Director, AstraZeneca
Lisa Kammerman, PhD is a Senior Statistical Director in Oncology at AstraZeneca. She consults on PRO projects and regulatory submissions. She developed AZ's PRO guidance document and led AZ's missing data project. After 24 years of public service, she retired from the FDA, where she... Read More →
EP

Elektra Papadopoulos

Associate Director, Clinical Outcome Assessments Staff, OND, CDER, FDA
Dr. Papadopoulos serves as the Associate Director of the Clinical Outcome Assessments Staff in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The staff provides consultation to CDER’s Review Divisions as well as other FDA Centers on clinical outcome... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm
S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  09: TranslSci-Preclin-Clin-ProdDev, Session