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Trk 17: Rare/Orphan Diseases [clear filter]
Tuesday, June 28
 

4:00pm EDT

#276: Using Input from Patient Communities to Develop PRO Instruments
Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-592-L04-P; CME 1.25; IACET 1.25; RN 1.25

Capturing quality of life via patient-reported outcomes (PROs) is critical to understanding the patient experience in the course of disease and treatment. This information can improve clinical care and the development of new therapies. Conventional approaches to developing PRO instruments rely heavily on input of leading physicians and cursory or indirect input from patients. Capturing more granular and direct input from patients on outcomes related to social impact, emotional impact, daily functional living, coping, disease and treatment burden, and satisfaction with therapies would be useful to building and validating a PRO instrument. In particular, online platforms for patient communities stand to accelerate and optimize collection of this input.

Learning Objectives

Describe the process for developing patient-reported outcome (PRO) instruments; Identify the challenges of developing PRO instruments; Explain the benefits and risks of using data and input from patient communities (including those online); Discuss alternate methods to develop PRO tools.

Chair

Badri Rengarajan, MD

Speaker

Engaging Online Communities to Understand Patient Experiences
Chad Gwaltney, PhD

Developing a Disease-Specific PRO Tool from a Patient-Centric Research Network
Badri Rengarajan, MD

Regulatory Perspective
Elektra Johanna Papadopoulos


Chair
avatar for Badri Rengarajan

Badri Rengarajan

Medical Affairs Lead, ASPIRE Unit, Actelion
15 years’ experience across medical affairs, product development strategy and new product planning, regulatory affairs, business development, strategy: Former Board President, International Pemphigus and Pemphigoid Foundation (rare disease foundation); Senior Medical Director, Archimedes... Read More →

Speakers
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 →
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 →

Tuesday June 28, 2016 4:00pm - 5:15pm EDT
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 17: Rare/Orphan Diseases, Session