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Monday, June 27 • 10:45am - 12:00pm
#132: Electronic Implementation of New PRO Measures to Assess Treatment Benefit in Irritable Bowel Syndrome Trials: Lessons Learned

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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.

Chair

Stephen Joel Coons, PhD

Speaker

Pharmaceutical Industry Perspective
David S. Reasner, PhD

ePRO Technology Provider Perspective
Cindy Howry, MS

ePRO Technology Provider Perspective
Adam Butler

FDA Perspective
Sarrit Kovacs



Chair
SC

Stephen Coons

Executive Director, PRO Consortium, Critical Path Institute
Stephen Joel Coons is Executive Director of the Patient-Reported Outcome (PRO) Consortium at the Critical Path Institute (C-Path). Stephen joined C-Path after a 23-year career in academia. For the past two decades, his primary research focus has been the measurement of patient-reported outcomes.

Speakers
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 and Trial Supply Management, Electronic Clinical Outcomes Assessments, Rater Training, and Quality Assurance. Mr. Butler has 14 years of experience working in... 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 of experience in management and leadership, including 17 years in the eCOA industry. Currently, she is VP of Product Strategy and Innovation for YPrime and... Read More →
avatar for Sarrit Kovacs

Sarrit Kovacs

Clinical Outcomes Assessments Reviewer, COA Staff, OND, CDER, FDA, FDA
Sarrit M. Kovacs is a reviewer with the Clinical Outcome Assessments (COA) Staff in the Center for Drug Evaluation and Research (CDER) at the FDA. She reviews qualitative and quantitative research in numerous disease areas, providing advice and consultation in CDER. Sarrit has over a decade and a half of social science research experience. Sarrit earned her Ph.D. in Developmental Science and a doctoral certificate in measurement from the... 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 lifecycle. The group integrates quantitative scientists with broadly enabling backgrounds in biostatistics, modeling, psychometrics, and survey methodology with... Read More →


Monday June 27, 2016 10:45am - 12:00pm
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA