Loading…
This event has ended. Visit the official site or create your own event on Sched.

View analytic
Tuesday, June 28 • 4:00pm - 5:15pm
#276: Using Input from Patient Communities to Develop PRO Instruments

Sign up or log in to save this to your schedule and see who's attending!

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; Director, BD and Market Research, Nodality; Regulatory Team Leader, Genentech; Junior Engagement Manager, McKinsey. Education: A.B., Biology and Public... 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 safety. His academic and industry research includes the design of electronic platforms for the collection of information in real-time in the patient’s natural... Read More →
EP

Elektra Papadopoulos

Acting Associate Director, Clinical Outcome Assessments Staff, OND, CDER, FDA
Elektra has been a medical officer at the FDA since 2001 and she currently serves as the Acting Associate Director of the Clinical Outcome Assessments Staff in the Office of New Drugs in CDER. The Staff provides internal consultation regarding clinical outcome assessment development and implementation across different therapeutic areas. The Staff also participates in guidance and policy development with regard to use of clinical outcome... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA