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TZID:America/New_York
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DTSTART:20241103T020000
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TZNAME:EST
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DTSTART:20250309T020000
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DESCRIPTION:NOTE: BIS 525 students are required to attend in person (47 Co
 llege St.\, Room 106A). All others are requested to attend via Zoom. SPEA
 KER : Codruta Chiuzan \, PhD\, Associate Professor\, Center for Personali
 zed Health\, Institute of Health System Science\, The Feinstein Institute
 s for Medical Research\, Northwell Health TITLE : “ Innovations in Immune
 -Oncology Early-Phase Trial Designs: Theory\, Practice and Next Steps ” A
 BSTRACT : The explosion of immunotherapeutic (I-O) agents for cancer trea
 tment has challenged the current assumptions of early-phase trial designs
 . The goal of determining the maximum tolerated dose (MTD) is no longer d
 esirable because novel agents are characterized by reduced toxicity profi
 les\, to the point of being essentially safe within the therapeutic dose 
 range. Recent phase I trials for single-agent or combination therapy have
  focused on detecting signals of antitumor activity\, pharmacokinetic / p
 harmacodynamics (PK/PD) relationships\, or on assessing feasibility and u
 tility of biological correlative assays. This presentation will discuss c
 hallenges brought by the new I-O agents and propose a novel statistical d
 esign for incorporating immunological endpoints into the dose-selection p
 rocess. The design uses a likelihood framework to assess safety and emplo
 ys randomization to skew patient allocation to the most promising/efficac
 ious doses. The proposed methodology will be illustrated via the R packag
 e iAdapt and Shiny app that enable the user to assess the design performa
 nce under various scenarios and to facilitate trial conduct in real time.
 \n\nSpeaker:\nCodruta Chiuzan\, PhD\n\nAdmission:\nFree\n\nDetails URL:\n
 https://medicine.yale.edu/event/ysph-biostatistics-virtual-seminar-tba-co
 py-4-copy/\n
DTEND;TZID=America/New_York:20211102T130000
DTSTAMP:20261031T211400Z
DTSTART;TZID=America/New_York:20211102T120000
GEO:41.302961;-72.931638
LOCATION:106-A\, 47 College Street\, New Haven\, CT\, United States
SEQUENCE:0
STATUS:Confirmed
SUMMARY:YSPH Biostatistics Seminar: "Innovations in Immune-Oncology Early-
 Phase Trial Designs: Theory\, Practice and Next Steps"
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