BEGIN:VCALENDAR VERSION:2.0 PRODID:-//132.216.98.100//NONSGML kigkonsult.se iCalcreator 2.20.4// BEGIN:VEVENT UID:20251006T153708EDT-2854uP7C8F@132.216.98.100 DTSTAMP:20251006T193708Z DESCRIPTION:Abstract: Phase I-II clinical trials combine the first two pha ses of conventional treatment evaluation by using both efficacy and toxici ty to decide whether a new treatment is acceptably safe and promising and\ , if so\, determine an optimal dose.  After preliminaries on commonly used phase I designs\,  I will describe a new sequentially adaptive Bayesian p hase I-II dose-finding design based on elicited utilities of a bivariate o rdinal (toxicity\, efficacy) outcome.  The methodology assumes parametric models for the marginal dose-toxicity and dose-efficacy distributions\, an d a copula is used to obtain a joint distribution. Using computer intensiv e methods\, prior means are derived from elicited outcome probabilities\, and prior variances are calibrated to control prior effective sample size and obtain a design with good frequentist operating characteristics. Subje ct to posterior dose acceptability criteria to control the risk of severe toxicity and exclude unpromising doses\, patients are randomized adaptivel y among the doses having posterior mean utilities near the maximum. The me thod is illustrated by two phase I-II trials: (i) optimizing biologically equivalent dose of radiation therapy for children with brain stem gliomas and (ii) optimizing dose of a BRAF inhibitor\, given with a fixed dose of tumor infiltrating lymphocytes\, for advanced melanoma. BIO: Peter Thall received his PhD in statistics and probability from The Florida State Uni versity Department of Statistics in 1975. He has worked at M.D. Anderson C ancer Center since 1990\, where he holds the Anise J. Sorrell Professorshi p. Dr. Thall has pioneered application of Bayesian methods in medical rese arch. He has designed over 300 clinical trials\, published over 180 papers and book chapters\, and presented 25 short courses and over 160 invited t alks. He has served as an Associate Editor for Statistics in Medicine\, Jo urnal of the National Cancer Institute\, and Biometrics. Currently\, he is an Associate Editor for Clinical Trials and Statistics in Biosciences\, a n American Statistical Association Media Expert\, a member of the Internat ional Biometric Society ENAR Regional Advisory Board\, and is the JSM 2013 Program Chair for the ASA Section on Bayesian Statistical Science.  He is the Principal Investigator of the NCI RO1 grant “Statistical Methods for Complex Cancer Trials.”   DTSTART:20130212T210000Z DTEND:20130212T220000Z LOCATION:Room 25 SUMMARY:Biostatistics Seminar - Dr Peter Thall - Utility Based Dose-Finding with Ordinal Toxicity and Efficacy URL:/epi-biostat-occh/channels/event/biostatistics-sem inar-dr-peter-thall-utility-based-dose-finding-ordinal-toxicity-and- END:VEVENT END:VCALENDAR