Refining Patient Reported Outcomes
Jean Paty, Ph.D.
– Chief Scientist and Regulatory Advisor
Dr. Paty has published extensively in the area of the regulations guiding development and implementation of ePRO, and has worked closely with industry and regulatory agency groups on ePRO best practices. His 17 years of work developing ePRO solutions to study patient experience has been well-referenced in peer reviewed journals and in a variety of conferences and events, where he has presented his findings on the scientific, clinical, and regulatory implications of PRO data collection in clinical trials. Dr. Paty has a B.S. in Psychology from University of Toronto and an M.S. and Ph.D. in Psychology from University of Pittsburgh.
Where to find Jean:
June 21, 2009 - DIA Annual 2009: San Diego, CA
Dr. Jean Paty will participate in "Computerized Systems Used in Clinical Research: Best Practices from Peach - Part 2 of 2" with a presentation on "Highlights from the Chapter on Data Collection". Dr. Jean Paty will also present “Using Handhelds to Collect Patient Data” as part of the session “Unique Challenges for Validation”. For more information, visit www.diahome.org
Webinar Replay: ePRO Regulatory Environment in Europe
Dr. Paty leads this interactive Web Seminar that explores various elements to consider for ensuring appropriate regulatory compliance in Europe when considering patient reported outcomes in your clinical research. View Webinar today!
Webinar Replay: Migration of PRO Measures from Paper to Electronic: Theoretical & Practical Perspectives
Dr. Paty conducted a discussion of the validation activities required to migrate PRO measures from paper to electronic; a discussion on the recent meta-analysis on the impact of moving from paper to electronic, and practical strategies to successfully migrate from paper to electronic in the context of the FDA draft PRO Guidance. - View webinar today!
Webinar Replay: Practical Implications of the FDA Draft PRO Guidance
Dr. Paty discussed life after the FDA’s Draft PRO Guidance, including Meaning of “Conceptual Framework” as defined by the FDA; Best practices in defining a solid endpoint model; Necessary steps to determine the validity of a PRO measure; and, Practical steps to migrate from paper to electronic patient reported outcomes (PROs). - View webinar today!