You are here:
Vanderbilt Biostatistics Wiki
>
Main Web
>
Seminars
>
WednesdaySeminarSeries
>
KeavenAnderson7Nov2018
(05 Nov 2018,
ThomasStewart
)
(raw view)
E
dit
A
ttach
%HEAD{ NAME="Keaven Anderson, !PhD" AFFILIATION=" Distinguished Scientist<br> Biostatistics and Research Decision Sciences<br> Merck" TITLE="Challenges with Design and Analysis in<br>Immuno-Oncology Trials " IMAGELINK="http://biostat.mc.vanderbilt.edu/wiki/pub/Main/KeavenAnderson7Nov2018/keavenanderson.jpg" }% The novel mechanism of action of immunotherapy agents, in treatment of various types of cancer, poses unique challenges during the design and analysis of clinical trials. The presence of non-proportional hazards (NPH) treatment effect has been well documented in the context of immuno-oncology (IO) studies, where a delayed separation of the Kaplan-Meier (KM) curves has often been observed. Other more complex forms of NPH, such as crossing KM curves are also seen in practice, which makes analytical approaches and interpretation of study results, even more challenging. A cooperative effort with the Pharmaceutical Industry was initiated by the FDA in late 2016 to take a holistic approach in understanding the impact of NPH in the design, analysis and interpretation of clinical trials. In this talk, we provide an overview of some of the efforts and then proceed to discuss the recommendations of a combination test based on weighted logrank tests. Power and Type I error will be discussed along with realistic examples to illustrate the method in practice. We will also discuss clinical trial design considerations in the context of a new treatment with a potentially delayed treatment effect. %TAIL{DATE="7 November 2018"}% <!-- * Set HEAD = <div class="w3-card-2" id="task" style="max-width:750px; margin-left: 0px;"> <header class="w3-container w3-blue" style="padding:40px"><h1>Biostatistics Weekly Seminar</h1><br><h2 style="color:white;">%TITLE%<br><br>%NAME%<br>%AFFILIATION%</h2></header><div class="w3-container" style="padding:40px"><IMG SRC=%IMAGELINK% align="left" id="mug"/> * Set TAIL = <br><h3>MRBIII, Room 1220<br>%DATE%<br>1:30pm</h3></div></div><br>[[%TOPIC%Itinerary][Speaker Itinerary]] --> <style> .w3-card-2,.w3-example{box-shadow:0 2px 4px 0 rgba(0,0,0,0.16),0 2px 10px 0 rgba(0,0,0,0.12)!important} .w3-blue,.w3-hover-blue:hover{color:#fff!important;background-color:#2196F3!important} .w3-container{padding:0.01em 16px} .foswikiTopic {font-family: 'Open Sans', sans-serif;} /* Removes location hierarchy (usually written in grey text) */ .patternHomePath {display:none;} /* Removes bar with edit and attach buttons and location hierarchy */ .patternTop{display:none;} h1, h2, h3, h4, h5, h6{font-family: 'Montserrat','Open Sans', sans-serif;font-weight:700;} h1, h2, h3, h4, h5, h6{color:#bf1735;} h1:first-of-type{color:#2a3e6e;margin-bottom:25px;margin-top:5px;} .foswikiImage{margin-left:-9px;} img#mug{padding-right: 40px; padding-bottom:25px; height:250px;} </style> -- Main.TawannaPeters - 30 Oct 2018
E
dit
|
A
ttach
|
P
rint version
|
H
istory
: r3
<
r2
<
r1
|
B
acklinks
|
V
iew topic
|
Edit
w
iki text
|
M
ore topic actions
Topic revision: r3 - 05 Nov 2018,
ThomasStewart
Main
Department Home Page
Biostatistics Graduate Program
Vanderbilt University Medical Center
Main Web
Main Web Home
Search
Recent Changes
Changes
Topic list
Biostatistics Webs
Archive
Main
Sandbox
System
Register
|
Log In
Copyright © 2013-2022 by the contributing authors. All material on this collaboration platform is the property of the contributing authors.
Ideas, requests, problems regarding Vanderbilt Biostatistics Wiki?
Send feedback