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This is the preliminary program for the 2009 Joint Statistical
Meetings in Washington, DC.
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The views expressed here are those of the individual authors and not necessarily those of the ASA or its board, officers, or staff. Back to main JSM 2009 Program page |
= Applied Session,
= Theme Session,
= Presenter| CE_16C | Mon, 8/3/09, 8:30 AM - 5:00 PM | RH-Renaissance Ballroom West A |
| Dose-Finding Studies: Methods and Implementation - Continuing Education - Course | ||
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ASA, Biopharmaceutical Section |
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| Instructor(s): Frank Bretz, Norvartis, Switzerland, Jose C. Pinheiro, Novartis Pharmaceuticals | ||
| Despite revolutionary advances in basic biomedical science, the number of new drug applications has been declining over the past several years. In response, different initiatives, such as the Critical Path Initiative, have been put in place to identify ways to address the key drivers of this pharmaceutical industry pipeline problem. One well-known cause is poor dose selection for confirmatory trials, resulting from inappropriate knowledge of dose response relationship (efficacy and safety) at the end of Phase II. This course will discuss the key statistical issues leading to the problems currently observed in dose-finding studies, including a review of basic multiple comparisons and modeling methods, as traditionally used in these studies. A unified strategy for designing and analyzing dose-finding studies, denoted MCP-Mod, combining multiple comparison and modeling, will be the major focus of the course. It will be discussed in detail, including a step-by-step description of its practical implementation. Case studies based on real clinical trials, together with software implemented in R, will be used to illustrate the use of the methodology. A practicum motivated by a real dose-finding study will allow attendees to get hands-on experience with the methods and R software. Attendees are encouraged to bring their laptops. Electrical outlets will be provided for each person attending the course. | ||
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JSM 2009
For information, contact jsm@amstat.org
or phone (888) 231-3473. If you have questions about the Continuing Education program,
please contact the Education Department. |