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:
April 17-19, 2012: PROficiency 2012: PROs and Beyond, invivodata’s 5th Annual Conference; Naples, FL
Follow the links below to access any of these recently recorded webinars in which Dr. Paty presented PRO and/or ePRO-focused topics:
Webinar Replay: Outcome Assessments: Review of FDA Workshop and Implications to New Drug Development
On October 19, FDA conducted a public workshop to discuss measurement principles for Outcome Assessments (OAs) used in clinical trials for new drugs. OAs include patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer reported outcome (ObsRO) measures. The workshop outlined FDA’s expectations for the development and qualification to establish that OAs are fit for purpose and appropriate for their context of use.
In this webinar, former FDA official Dr. John Powers and invivodata/PRO Consulting’s Dr. Jean Paty reviews the key take-aways from the FDA workshop and discusses the implications to researchers using OAs in new medical product development. Specific focus on choice and development of different types of outcomes will be reviewed, including the importance of content validity, reliability, construct validity and other measurement properties for all types of outcomes that are strategic to product development. Listen now!
Webinar Replay: PRO Regulatory Update: Migrating Instruments from Paper to Electronic Format
This webinar will focus on the necessary considerations when migrating a PRO instrument from a paper to electronic format. The presenters will discuss the regulatory recommendations and what needs to be evaluated to ensure there has been no impact on the interpretation and understanding of the instrument. The published industry best practices will be used as the basis of the discussion. Listen to the Webinar recording today!
Webinar Replay: Interpreting Regulatory Feedback on PRO Instruments: Now What?
In this interactive webinar, Dr. Jean Paty and Katarina Halling review some common pitfalls of PRO-based research and offer direction on adhering to regulatory guidance. They present examples of researchers who, upon receiving feedback from FDA, took appropriate steps to revise their PRO strategies to meet regulatory scrutiny and continue in their development plans. View Webinar today!
Webinar Replay: How do you know your Drug Works?
In this webinar, Dr. Jean Paty reviews how PRO instrument selection is strategic in drug development, the essential considerations in developing a successful PRO strategy and how your PRO measurement strategy can help differentiate your product. View Webinar today!
Webinar Replay: Implementing PROs in Clinical Trials
In this webinar, Dr. Jean Paty shares insight regarding the incorporation of patient reported outcomes measures in clinical trials. View Webinar today!
Webinar Replay: ePRO Industry Best Practice and Regulatory Considerations: An Update on Issues that Affect your Clinical Trials
Dr. Paty discusses best practices for the ePRO industry in consideration of the current regulatory environment. View Webinar today!
Webinar Replay: Final PRO Guidance Insight from invivodata
Dr. Paty reviews the FDA final guidance on patient reported outcomes and its impact on clinical trial sponsors. View Webinar today!
Webinar Replay: Leveraging the Value of ePRO Early in Clinical Trials
In this webinar, Dr. Jean Paty discusses methods to improve measure sensitivity in early stage research, including a review of the scientific and regulatory rationale for developing and validating PRO measures and implementing electronic PRO methods in Phase II clinical trials. Dr. Paty also covers the real-world value of using ePRO early in clinical development, including the practical benefits of justifying study investment to both internal and external audiences. View Webinar today!
