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DTSTART:20241103T020000
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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 : Brian P. Hobbs \, PhD\, Associate Professor\, Department of Populat
 ion Health\, University of Texas at Austin TITLE : “Does Real-World Evide
 nce have a role in Precision Oncology?" ABSTRACT: The FDA instituted a pr
 ogram for Accelerated Approval in 1992\, which allowed for approvals on t
 he basis of surrogate endpoints for drugs treating serious conditions tha
 t filled an unmet medical need. The Food and Drug Administration Safety I
 nnovations Act\, passed in 2012\, allows accelerated approvals for approp
 riate drugs and indications by evaluating the effects of drugs on surroga
 te markers. More recently\, the FDA has established three additional path
 ways to speed the review process for emerging therapies. These changes pr
 ompted innovations in trial design with master protocol and seamless desi
 gns. Immune checkpoint inhibitors (ICIs) have yielded promising therapies
  for patients experiencing refractory cancers. Trials evaluating ICIs mad
 e extensive use of phase Ib\, enrolling hundreds and even more than one t
 housand patients into dose expansion cohorts following dose-escalation sp
 anning multiple tumor types. This represents a departure from conventiona
 l drug development strategies\, for which dose expansion cohorts were use
 d in roughly 25% of phase trials. Moreover\, in 2021 two drugs\, Atezoliz
 umab and Durvalumab\, were voluntarily withdrawn from accelerated approva
 ls for PD-L1 inhibition in advanced or metastatic bladder cancer. This pr
 esentation considers the statistical implications of expansive\, uncontro
 lled early phase trials and discusses the potential role for real-world e
 vidence in this setting. Keywords: Bayesian\, clinical trials\, real-worl
 d data\, seamless design\, cancer\n\nSpeaker:\nBrian P. Hobbs\, PhD\n\nAd
 mission:\nFree\n\nDetails URL:\nhttps://medicine.yale.edu/event/ysph-bios
 tatistics-virtual-seminar-tba-copy-6/\n
DTEND;TZID=America/New_York:20211207T130000
DTSTAMP:20261013T074837Z
DTSTART;TZID=America/New_York:20211207T120000
GEO:41.302961;-72.931638
LOCATION:106-A\, 47 College Street\, New Haven\, CT\, United States
SEQUENCE:0
STATUS:Confirmed
SUMMARY:YSPH Biostatistics Seminar: “Does Real-World Evidence have a role 
 in Precision Oncology?”
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