BEGIN:VCALENDAR VERSION:2.0 PRODID:-//132.216.98.100//NONSGML kigkonsult.se iCalcreator 2.20.4// BEGIN:VEVENT UID:20260602T084435EDT-9789lGh11x@132.216.98.100 DTSTAMP:20260602T124435Z DESCRIPTION:Title: The psychometrics of clinical trial endpoints derived fr om patient-reported outcome measures: Causal inference validity.\n\n\n \n \n \n Abstract\n\n The US Food and Drug Administration increasingly emphasizes the importance of assessing how patients “feel\, function\, and survive” w hen evaluating new treatments in clinical trials\, often via the use of en dpoints derived from patient-reported outcome measures (PROs). This presen tation examines possible pitfalls in using PRO-derived endpoints to estima te and test hypotheses about treatment effects. It discusses the notion of whether endpoints possess “causal inference validity\,” and presents infe rential remedies when such validity is not achieved. The pitfalls and reme dies are exemplified in a simulation study using the Rasch item response t heory measurement model to analyze a PRO.\n\n Speaker bio\n\n Ed Bein is on sabbatical from the US Food and Drug Administration\, where he is a senior statistician at the Center for Drug Evaluation and Research. He has revie wed randomized trials evaluating treatments for infectious diseases\, incl uding COVID-19 and observational studies of the long-term safety of recent ly approved drugs. He has a Ph.D. in biostatistics from UC Berkeley and wa s a clinical psychologist in his previous career.\n\n NOTE: Social gatherin g (Open area outside Rm1140) from 3-3:30pm\n \n \n \n\n DTSTART:20230308T203000Z DTEND:20230308T213000Z LOCATION:Room 1140\, 91 College 2001\, CA\, QC\, Montreal\, H3A 1G1\, 2 001\, avenue 91 College SUMMARY:Edward Bein URL:/mathstat/channels/event/edward-bein-346584 END:VEVENT END:VCALENDAR