Jim, in case you didn't get this email. "Jeff Ahrnsen" <jeff@xxxxxxxxxxx> Sent by: cinsug-bounce@xxxxxxxxxxxxx 01/25/2005 11:39 AM Please respond to cinsug To: <cinsug@xxxxxxxxxxxxx> cc: (bcc: Glen Chabi-GH/PGI) Subject: [CinSUG] Upcoming CinSUG Meeting 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