BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:Central Standard Time BEGIN:STANDARD DTSTART:20251102T020000 RRULE:FREQ=YEARLY;BYDAY=1SU;BYHOUR=2;BYMINUTE=0;BYMONTH=11 TZNAME:Central Standard Time TZOFFSETFROM:-0500 TZOFFSETTO:-0600 END:STANDARD BEGIN:DAYLIGHT DTSTART:20250301T020000 RRULE:FREQ=YEARLY;BYDAY=2SU;BYHOUR=2;BYMINUTE=0;BYMONTH=3 TZNAME:Central Daylight Time TZOFFSETFROM:-0600 TZOFFSETTO:-0500 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Feel free to share this announcement with colleagues who may be interested.\nAbstractRandomized Controlled Trials (RCTs) are an indispens able source of evidence for evaluating the efficacy of treatments across n early all disease areas. With the growing availability of multiple treatme nt options\, Comparative Effectiveness Research (CER) has \;gained inc reasing importance in supporting informed healthcare decisions. However\, the design and analysis of effectiveness trials are significantly more com plex than those of traditional efficacy trials. A major factor contributin g to this complexity is the \;inclusion of active comparator arm(s) in RCTs\, which gives rise to superiority and non-inferiority (NI) trial des igns. Among these\, the non-inferiority design plays a fundamental role in CER and will be a key focus of this talk. Non-inferiority (NI) trials&nbs p\;are inherently complex\, as they typically involve active control and r equire the specification of a non-inferiority margin a priori. Additional complications arise when the outcome of interest is not continuous\, such as binary\, count or time-to-event outcomes. \;In this talk\, Dr. Ghos h will provide a broad overview of the key challenges in designing and ana lyzing NI trials\, drawing from his decade-long work in this area. Dr. Gho sh will also present examples highlighting specific difficulties when the outcome of interest \;is time-to-event and discuss methodological cons iderations and potential solutions.HybridIn-person: UHC 4.108Zoom: Link(Lu nch will be provided if attending in person) DTEND:20251021T180000Z DTSTAMP:20260717T082223Z DTSTART:20251021T170000Z LOCATION: SEQUENCE:0 SUMMARY:DMAC CERCIT Seminar Series: Challenges in Non-Inferiority Testing UID:RFCALITEM639198553431114303 X-ALT-DESC;FMTTYPE=text/html:

< strong>Feel free to share this announcement with colleagues who may be int erested.

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Abstract

Randomized Controlled Trials (RCTs) a re an indispensable source of evidence for evaluating the efficacy of trea tments across nearly all disease areas. With the growing availability of m ultiple treatment options\, Comparative Effectiveness Research (CER) has&n bsp\;gained increasing importance in supporting informed healthcare decisi ons. However\, the design and analysis of effectiveness trials are signifi cantly more complex than those of traditional efficacy trials. A major fac tor contributing to this complexity is the \;inclusion of active compa rator arm(s) in RCTs\, which gives rise to superiority and non-inferiority (NI) trial designs. Among these\, the non-inferiority design plays a fund amental role in CER and will be a key focus of this talk. Non-inferiority (NI) trials \;are inherently complex\, as they typically involve activ e control and require the specification of a non-inferiority margin a prio ri. Additional complications arise when the outcome of interest is not con tinuous\, such as binary\, count or time-to-event outcomes. \;In this talk\, Dr. Ghosh will provide a broad overview of the key challenges in de signing and analyzing NI trials\, drawing from his decade-long work in thi s area. Dr. Ghosh will also present examples highlighting specific difficu lties when the outcome of interest \;is time-to-event and discuss meth odological considerations and potential solutions.

Hybrid
In-person: UHC 4.108
Zoom: Link

(Lunch will be provided if attending in person) END:VEVENT END:VCALENDAR