JSM Preliminary Online Program
This is the preliminary program for the 2009 Joint Statistical Meetings in Washington, DC.

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Activity Number: 481
Type: Roundtables
Date/Time: Wednesday, August 5, 2009 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304035
Title: Advanced Oncology Trial Designs
Author(s): Mingxiu Hu*+
Companies: Millennium Pharmaceuticals/The Takeda Oncology Company
Address: 35 Landsdowne Street, Cambridge, MA, 02139,
Keywords: oncology trial ; adaptive design ; phase II/III seamless design ; accelerated titration ; sample size re-estimation ; Simon's two-stage design
Abstract:

Oncology is a hotly pursued therapeutic area right now and in decades to come. Due to highly unmet medical needs, pharmaceutical/biotech companies employ many novel designs to accelerate oncology drug development. These include CRM and accelerated titration for phase I, Simon's two-stage design and three stage design for phase II, Phase I/II combined trial, phase II/III seamless design, sample size re-estimation, superiority/non-inferiority switch, etc. It seems that adaptive design is more acceptable in the oncology area comparing to other traditional therapeutic areas. Is this true? In this lunch discussion, I would like to share the types of advanced designs we have applied in our oncology trials and would also like to learn any interesting designs others may have used in their trials.

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Revised September, 2008