[CinSUG] Upcoming CinSUG Meeting

  • From: "Jeff Ahrnsen" <jeff@xxxxxxxxxxx>
  • To: <cinsug@xxxxxxxxxxxxx>
  • Date: Tue, 25 Jan 2005 11:39:40 -0500

Cincinnati SAS User Group
Date       :  February 10, 2005
Location: Procter & Gamble Company's Health Care Research Center in Mason,
Ohio 

                 in room DV1!-105  
Time      : 4:00 PM 
Speaker:  Dr. Alex Dmitrienko, PhD at Eli Lilly and Company
Topic        Analysis of Clinical Trials Using SAS: A Practical Guide 
Comment:   For more information, visit www.cinsug.org


The next CinSUG meeting will be held Thursday, February 10, 2005 at 4:00
P.M. in room DV1-105 at The Procter & Gamble Company's Health Care Research
Center facility in Mason, Ohio - 8700 Mason-Montgomery Road.  We are very
excited to welcome Alex Dmitrienko, PhD, Eli Lilly and Company.  Dr.
Dmitrienko will discuss a new book he co-authored titled Analysis of
Clinical Trials Using SAS: A Practical Guide.  An abstract is given below.
This meeting is being jointly sponsored by the Cincinnati Chapter of the
American Statistical Association and we have scheduled approximately 2
hours, so please plan accordingly.  Upon arrival, go to the main lobby in
order to be escorted to the conference room. 
 
Abstract of Talk 


Analysis of Clinical Trials Using SAS: A Practical Guide 
(a new book by A. Dmitrienko, G. Molenberghs, C. Chuang-Stein and W. Offen) 
Alex Dmitrienko, PhD 
Principal Research Scientist, Eli Lilly and Company



This talk will introduce a recently published biostatistical book written by
A. Dmitrienko (Lilly), G. Molenberghs (Limburgs Universitair Centrum,
Belgium), C. Chuang-Stein (Pfizer) and W. Offen (Lilly). This book focuses
on key problems arising in the context of clinical trials and medical
research in general, including analysis of stratified data, multiple
comparisons, interim safety and efficacy monitoring, analysis of incomplete
data and analysis of safety and diagnostic measurements. The book discusses
solutions to these problems based on modern statistical methods and reviews
SAS techniques that help clinical researchers efficiently and rapidly
implement these methods.   

To illustrate the methods discussed in the book, this talk describes methods
for addressing multiplicity issues arising in the analysis of clinical
trials with multiple primary and secondary objectives. Regulatory agencies
and pharmaceutical companies have long debated how to interpret significant
secondary findings and whether significant secondary findings can be
included in the product label. Efficient solutions for multiplicity problems
of this kind can be obtained using "gatekeeping strategies" when the primary
analyses are treated as gatekeepers and the secondary analyses are performed
only if one or more gatekeeper analyses have yielded a significant outcome.
Similar gatekeeping strategies can be used in dose-ranging trials. The
outlined gatekeeping strategies are illustrated using examples from pivotal
trials with multiple primary and secondary endpoints (trials in patients
with depression and acute lung injury) and dose-finding trials (trial in
patients with hypertension). 
  
  
Directions to The Procter & Gamble Co.'s Health Care Research Center (8700 S
Mason Montgomery Rd, Mason OH 45040) 
Take I-71 to Exit 19. 

*       If exiting from I-71 southbound, keep right to stay on ramp towards
Mason Montgomery Rd and then turn right (north) onto S Mason Montgomery Rd.
P&G's HCRC facility is about 1.1 miles on your right (just past Irwin
Simpson Rd).  Visitor parking is available at the front of the building. 
*       If exiting from I-71 northbound, turn left (north) at light off exit
ramp onto Mason Rd and continue until you go under I-71.  The road name will
change to S Mason Montgomery Rd.  P&G's HCRC facility is about 1.3 miles on
your right (just past Irwin Simpson Rd).  Visitor parking is available at
the front of the building. 
For a map, visit or click on http://www.google.com
<http://www.google.com/search?sourceid=navclient&ie=UTF-8&q=8700+S+Mason+Mon
tgomery+Rd,+Mason,+OH+45040>  and search for "8700 S Mason Montgomery Rd,
Mason OH 45040" (quotes can be omitted).  Click on links at top of results
to see a map. 

 

 

Regards,

Jeff Ahrnsen

CinSUG

 




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