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UID:20260707T102021EDT-21637oSpT0@132.216.98.100
DTSTAMP:20260707T142021Z
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\, McGill College 2001\, CA\, QC\, Montreal\, H3A 1G1\, 2
 001\, avenue McGill College
SUMMARY:Edward Bein
URL:https://www.mcgill.ca/mathstat/channels/event/edward-bein-346584
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