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Disease Specific [clear filter]
Monday, June 27

10:45am EDT

#132: Electronic Implementation of New PRO Measures to Assess Treatment Benefit in Irritable Bowel Syndrome Trials: Lessons Learned
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-540-L01-P; CME 1.25; IACET 1.25; RN 1.25

This forum describes the electronic implementation of patient-reported outcomes (PRO)-based endpoint measures developed by the PRO Consortium for irritable bowel syndrome treatment trials. The panel will share lessons learned when pairing technology with clinical measurement.

Learning Objectives

Describe advantages of collecting clinical trial endpoint data electronically, particularly with patterns of data as observed in irritable bowel syndrome treatment trials; Discuss how regulatory agencies view the electronic capture of endpoints in clinical trials; Distinguish between operational and measurement aspects of the electronic implementation of PRO instruments used to assess endpoints in clinical trials.


Stephen Joel Coons, PhD


Pharmaceutical Industry Perspective
David S. Reasner, PhD

ePRO Technology Provider Perspective
Cindy Howry, MS

ePRO Technology Provider Perspective
Adam Butler

FDA Perspective
Sarrit Kovacs

avatar for Stephen Joel Coons

Stephen Joel Coons

Executive Director, PRO Consortium, Critical Path Institute
Stephen Joel Coons is Executive Director of the Patient-Reported Outcome (PRO) Consortium at Critical Path Institute (C-Path). C-Path, an independent nonprofit organization, established the PRO Consortium in cooperation with the U.S. Food and Drug Administration and the pharmaceutical... Read More →

avatar for Adam Butler

Adam Butler

Senior Vice President, Strategic Development and Corporate Marketing, Bracket
Mr. Butler is the Senior Vice President of Strategic Development at Bracket. Bracket offers a unique suite of solutions, with a unique perspective on clinical research development. Mr. Butler is responsible for Strategic Development for Bracket’s service offerings in Randomization... Read More →
avatar for Cindy Howry

Cindy Howry

Vice President, Product Strategy and Innovation, YPrime Inc
Cindy Howry is nationally recognized thought-leader in the area of eCOA which empowers the patient and engages them to maintain and improve their health, simultaneously enabling clinical teams to have real-time access to better quality clinical data. Ms. Howry has more than 30 years... Read More →
avatar for Sarrit Kovacs

Sarrit Kovacs

Clinical Outcome Assessments (COA) Staff, OND, CDER, FDA
Sarrit Kovacs, PhD is a reviewer with the Clinical Outcome Assessments (COA) Staff in the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) at FDA. Sarrit has nearly 20 years of social science research experience and is a consultant to CDER and other... Read More →
avatar for David Reasner

David Reasner

President and Founder, Albemarle Scientific Consulting LLC
David is VP, Data Science and Head, Study Endpoints at Ironwood Pharmaceuticals located in Cambridge, Massachusetts. The Data Science group is responsible for development of analytical strategies bridging early phase research through development into the biopharmaceutical product... Read More →

Monday June 27, 2016 10:45am - 12:00pm EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Forum