This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 583
Type: Contributed
Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #308034
Title: Case Study: Benefits of an Adaptive Clinical Trial Design in Oncology
Author(s): Darcy Hille*+ and Christine K. Gause and Jason B. Clark and Sarah Hoagey and Keaven M. Anderson
Companies: Merck & Co., Inc. and Merck Research Laboratories and Merck Research Laboratories and Merck & Co., Inc. and Merck Research Laboratories
Address: UG1C-46, North Wales, PA, 19454,
Keywords: adaptive trial design ; interim analysis ; oncology
Abstract:

Adaptive clinical trial designs are thought to offer benefits in terms of reduced cycle times, number of patients, and costs compared to classical designs, but this has yet to be fully established. This is a case study of a Phase II clinical study to evaluate an anticancer chemotherapy. As part of an adaptive design strategy, the study includes three interim analyses for futility. Statistical simulations were conducted to evaluate the performance of the design, which included estimating the probability of stopping at each interim analysis. The adaptive design was compared to the classical alternative which would not have futility analyses. Initial estimates showed benefits for the adaptive design with a reduced cycle time of 15 months, number of patients of 121, and grant costs of $3.8 million, all adjusted for the probability of stopping at each interim analysis.


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