Dear Colleagues,
Please find details below of an hour long, educational web tutorial relating to ePRO validation and statistical analysis of validation studies. The webinar will be given from a scientific viewpoint - it will not be Company promotional.
http://www.perceptive.com/news/webcast-registration.html?webcast_id=71
If you are interested, please register at the link above - there is no need to reply direct to me, although I am happy to answer any queries on content, timing or registration.
Kind regards
Malcolm
Malcolm Morrissey
Perceptive Informatics
Join us for a 60-minute webinar that will address design, implementation and results of an ePRO validation study as well as how to analyze these types of studies.
Patient reported outcomes (PROs; self-report assessments) are critically important to the biopharmaceutical industry in evaluating treatment efficacy from the patient’s perspective. The FDA and EMEA accept electronic PRO (ePRO) measures; however, the general guidance is that any data collected electronically must be accompanied by sufficient evidence to support the measurement equivalence of the electronic and original paper-based instrument.
This webinar will discuss a recently completed validation of the electronic versions of the EQ-5D and the QLQ-C30, two commonly used health-related quality of life instruments. Stephen Coons will discuss recommended best practices for ePRO validation as well as describe the design, conduct and results from a real world measurement equivalence study. Damian McEntegart will outline the best statistical design and analysis methods and illustrate these with examples.
Attendees will achieve an understanding of:
· The types of validation for PROs/ePRO and the associated considerations
· How a real world ePRO validation study was designed and conducted
· The measurement equivalence of electronic versions of two HRQL instruments
· Industry best practices on how to analyze and report ePRO validation data
Who should attend:
· Health Outcomes Researchers
· Health Economists
· Clinical Research Physicians
· Clinical Operations
· Data Management
· Statisticians
· PRO Instrument Developers
Hear from the following experts:
Stephen J. Coons, Ph.D.
Professor of Pharmacy and Public Health, University of Arizona
Stephen heads a research program focusing on the assessment of outcomes associated with disease and its treatment. His particular interest is measurement of the impact of pharmaceuticals on patient-reported outcomes (PROs), such as health-related quality of life. Stephen chaired ISPOR's ePRO Best Practices Task Force, which developed recommendations regarding the adaptation of existing PRO measures to electronic modes of administration.
Damian McEntegart, M.S.
Senior Director of Global Operations - Statistics & Special Services, Perceptive Informatics
Damian McEntegart oversees Perceptive’s specialist support on randomization methods, medication management algorithms and electronic patient reported outcomes. Damian has published over 40 articles and letters on these topics.
Registration
This webinar is open exclusively to pharmaceutical and biotechnology companies.
Registration is complimentary.
Sign up here for this 1 hour FREE event
http://www.perceptive.com/news/webcast-registration.html?webcast_id=71
You will be able to select the event time on the registration page.
Please share this invitation with any interested colleagues. But hurry, spaces are booking fast!
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