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Tuesday, June 20 • 2:00pm - 3:15pm
#258: Patient-Reported Outcomes (PROs): Hot Topics - Part 1 of 2

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-556-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patient-reported outcomes (PROs)are not new. The FDA released a final guidance on this topic in 2009, and there have been many presentations and discussions on the evidence and measurement principles used to guide development of fit-for-purpose PRO assessments. This session will move the conversation from basic PRO development to discuss the latest hot topics regarding PROs in drug development. Hot topics might include (but are not limited to): FDA's flexibility in implementing principles in the guidance; methods to evaluate meaningful change on PRO assessments; strategies for incorporating PRO endpoints into multiplicity-adjusted endpoint hierarchy with traditional endpoints; novel methods to validate new PRO tools).

Learning Objectives

Summarize practical insights and methods that can be used to facilitate the development and use of PROs in clinical trials.


Selena Daniels, PharmD, MS


Capturing the Patient's Voice in Evaluating Safety and Tolerability: Industry Perspective
Arnold Degboe, MD, PhD, MBA

Capturing the Patients’ Voice in the Evaluation of Safety and Tolerability: FDA Perspective
Paul Kluetz, MD

Capturing the Patients’ Voice in the Evaluation of Safety and Tolerability: FDA Perspective
Ann Marie Trentacosti, MD

avatar for Selena Daniels

Selena Daniels

COA Staff Team Leader, Office of New Drugs, CDER, FDA
Selena Daniels is a Team Leader on the Clinical Outcome Assessments (COA) Staff at FDA. Selena leads a team of expert analysts who evaluate COA endpoint issues related to the evaluation of clinical benefit in clinical trials to support labeling claims. Prior to the FDA, she was a... Read More →
avatar for Arnold Degboe

Arnold Degboe

Director, Patient Science-Oncology, Patient Centricity, Global Medical Affairs, AstraZeneca
Arnold is a physician by training and a health economics & outcomes researcher with over 16 years of combined experience in clinical practice, outcomes research and pharma. He holds a medical degree from Ghana, and a dual-titled Ph.D. in Health Policy & Demography from Penn State... Read More →
avatar for Paul Kluetz

Paul Kluetz

Associate Director for Patient Outcomes (Acting), OCE, FDA
Paul G. Kluetz, M.D., is a medical oncologist and the Acting Associate Director of Patient Outcomes in the Oncology Center of Excellence at the U.S. FDA. He is interested in defining clinical benefit in oncology trials, the use of expedited programs such as accelerated approval and... Read More →
avatar for Ann Marie Trentacosti

Ann Marie Trentacosti

Medical Officer, Labeling Development Team, OND, CDER, FDA
Dr. Ann Marie Trentacosti is the Medical Lead for the Labeling Development Team (LDT) in the Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). LDT ensures that the prescribing information is a useful communication tool... Read More →

Tuesday June 20, 2017 2:00pm - 3:15pm CDT
S404d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  09: TranslSci-Preclin-Clin-ProdDev, Session