BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 13.3//EN BEGIN:VTIMEZONE TZID:GMT Standard Time BEGIN:STANDARD DTSTART:20231002T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=2;BYMINUTE=0;BYMONTH=10 TZNAME:GMT Standard Time TZOFFSETFROM:+0100 TZOFFSETTO:+0000 END:STANDARD BEGIN:DAYLIGHT DTSTART:20230301T010000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=1;BYMINUTE=0;BYMONTH=3 TZNAME:GMT Daylight Time TZOFFSETFROM:+0000 TZOFFSETTO:+0100 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:PSI Scientific Committee Webinar: Heart Failure Trials: Novel E stimands and Methodologies to Evaluate Therapies based on the Totality of Evidence Heart failure (HF) is a common and global health problem affectin g approx. 2% of adults in developed countries. Good news is that with new treatments on the market\, HF has been converted from a short-term and qui ckly fatal condition to a chronic disease\, which is characterized by recu rrent non-fatal events (HF hospitalizations) and relatively low disease-re lated mortality. Classical heart failure trials have used a composite prim ary endpoint of cardiovascular (CV) death and HF hospitalization. This end point was then analyzed using a &lsquo\;time to first composite event&rsqu o\; analysis. \; Various limitations of this endpoint have been raised in recent years. Among others\, the &lsquo\;time \;to first composite event&rsquo\; endpoint is thought to not fully capture the disease burden as it \;ignores all events that occur after the first event. Given th at a number of recent large HF \;\noutcome trials have failed to show a clinical benefit for patients using the traditional endpoint\, \;cli nical teams are reviewing novel endpoints that better capture clinical ben efit and which\nadapt to the changing disease profile. In this session\, w e will discuss some of the recently proposed estimands and their associate d \;analysis methods\, ranging from composite endpoints of recurrent H F hospitalizations (HFH) \;and death to joint frailty models for recur rent HFH and death. We will illustrate these \;approaches based on var ious case-studies and discuss benefits as well as limitations from an  \;academic\, regulatory and industry perspective. Application of Recurrent Events Methodology in Cardiovascular Trials\nDr. Brian Claggett (Harvard Medical School) We describe a range of alternative models for recurrent ev ents data collected in cardiovascular trials. We consider their applicabil ity and interpretation from a medical context and illustrate them using da ta from a particular trial. The Totality of Evidence: Is More the Same as Better?\nDr. Bruce Binkowitz (Merck) Analysis of time to first event is a long held tradition for trials in the cardiovascular area\, including hear t failure. Yet subjects in these studies can experience more than 1 event. Recent literature has focused on utilizing all events experienced by each subject as a way of increasing efficiency through having to enroll less s ubjects\, use less investigator sites\, and save money. Consideration for examining all events further extends to measuring total patient burden\, c ost effectiveness\, and most importantly\, capturing the best picture of a subject's condition and therefore the best potential therapy. This presen tation will discuss how analyzing total events isn't as simple as designin g a traditional time to first event study and\, for example\, running an A nderson-Gill extension to a Cox PH model on all events. Examples will be t aken from actual trials including a trial examining subjects with acute de compensated heart failure.\n \; Recurrent or Multiple Event Analyses i n Cardiovascular Trials \;\nDr. H.M. James Hung\, US FDA In cardiovasc ular or renal trials that we have seen in regulatory applications\, major adverse clinical events are almost always assessed using analysis of time to first occurrence of the events. As some component events occur much mor e frequently\, such as hospitalizations\, during the trial\, the analysis that includes all the events may improve statistical efficiency and captur e disease burden of patients more properly. In this talk\, I shall share a number of regulatory experiences with recurrent or multiple event analyse s to give my insights into the possible values of such analysis and to sti pulate the issues that need more attention. Registration fee: None This we binar is free of charge. However\, attendees must register on the PSI webs ite in order to obtain the dial-in details and the webinar link. We do enc ourage your participation. If you have questions relating to this webinar\ , or any of the listed talks\, ahead of the webinar\, please email them to  \;Mouna.Akacha@novartis.com \nWe will do our best to discuss them at the webinar. DTEND:20141016T150000Z DTSTAMP:20240328T223717Z DTSTART:20141016T130000Z LOCATION: SEQUENCE:0 SUMMARY:Heart Failure Trials and Recurrent Events UID:RFCALITEM638472622373608494 X-ALT-DESC;FMTTYPE=text/html:
PSI Scientific Committee Webinar: H eart Failure Trials: Novel Estimands and Methodologies to Evaluate Therapi es based on the Totality of Evidence
Heart failure (HF) is a common and global health problem affecting approx. 2% of adults in deve loped countries. Good news is that with new treatments on the market\, HF has been converted from a short-term and quickly fatal condition to a chro nic disease\, which is characterized by recurrent non-fatal events (HF hos pitalizations) and relatively low disease-related mortality. Classical hea rt failure trials have used a composite primary endpoint of cardiovascular (CV) death and HF hospitalization. This endpoint was then analyzed using a &lsquo\;time to first composite event&rsquo\; analysis. \;
Va rious limitations of this endpoint have been raised in recent years. Among others\, the &lsquo\;time \;to first composite event&rsquo\; endpoint is thought to not fully capture the disease burden as it \;ignores al l events that occur after the first event. Given that a number of recent l arge HF \;\noutcome trials have failed to show a clinical benefit for patients using the traditional endpoint\, \;clinical teams are reviewi ng novel endpoints that better capture clinical benefit and which\nadapt t o the changing disease profile.
In this session\, we will discuss s ome of the recently proposed estimands and their associated \;analysis methods\, ranging from composite endpoints of recurrent HF hospitalizatio ns (HFH) \;and death to joint frailty models for recurrent HFH and dea th. We will illustrate these \;approaches based on various case-studie s and discuss benefits as well as limitations from an \;academic\, reg ulatory and industry perspective.
Application of Recurrent
Events Methodology in Cardiovascular Trials
\nDr. Brian Claggett (Har
vard Medical School)
We describe a range of alternative mo dels for recurrent events data collected in cardiovascular trials. We cons ider their applicability and interpretation from a medical context and ill ustrate them using data from a particular trial.
The Totali
ty of Evidence: Is More the Same as Better?
\nDr. Bruce Binkowitz (Me
rck)
Analysis of time to first event is a long held tradit
ion for trials in the cardiovascular area\, including heart failure. Yet s
ubjects in these studies can experience more than 1 event. Recent literatu
re has focused on utilizing all events experienced by each subject as a wa
y of increasing efficiency through having to enroll less subjects\, use le
ss investigator sites\, and save money. Consideration for examining all ev
ents further extends to measuring total patient burden\, cost effectivenes
s\, and most importantly\, capturing the best picture of a subject's condi
tion and therefore the best potential therapy. This presentation will disc
uss how analyzing total events isn't as simple as designing a traditional
time to first event study and\, for example\, running an Anderson-Gill ext
ension to a Cox PH model on all events. Examples will be taken from actual
trials including a trial examining subjects with acute decompensated hear
t failure.
\n \;
Recurrent or Multiple Event Analys
es in Cardiovascular Trials \;
\nDr. H.M. James Hung\, US FDA
In cardiovascular or renal trials that we have seen in regula tory applications\, major adverse clinical events are almost always assess ed using analysis of time to first occurrence of the events. As some compo nent events occur much more frequently\, such as hospitalizations\, during the trial\, the analysis that includes all the events may improve statist ical efficiency and capture disease burden of patients more properly. In t his talk\, I shall share a number of regulatory experiences with recurrent or multiple event analyses to give my insights into the possible values o f such analysis and to stipulate the issues that need more attention.
Registration fee: None
This webinar is free of charge. However\, attendees must register on the PSI website in order to o btain the dial-in details and the webinar link.
We do encourage you
r participation. If you have questions relating to this webinar\, or any o
f the listed talks\, ahead of the webinar\, please email them to \;Mouna.Akacha@novartis.com
\nWe will do our best to discuss them at the webinar.