Abstract #301120

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JSM 2002 Abstract #301120
Activity Number: 92
Type: Topic Contributed
Date/Time: Monday, August 12, 2002 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section*
Abstract - #301120
Title: Practical Issues in Planning Cross-over Trials in Drug Development
Author(s): Stephen Senn*+
Affiliation(s): University College London
Address: 1-19 Torrington Place, London, International, WC1E 6BT, United Kingdom
Keywords: Carry-over ; Patient by treatment interaction ; Incomplete blocks
Abstract:

Some practical issues in planning cross-over trials will be considered. A general approach to sample size determination for any arbitrary cross-over will be described. This also permits sample size determination when it is intended to recover inter-block information for incomplete block cross-overs. Consideration will also be given to planning to mimimize the effect of carry-over. Some aspects of period effects will also be covered and implications for use of baselines. Some "optimal" designs will be critically assessed. Finally, a neglected use of cross-overs, for resolving components of variation, will be covered. It will be concluded that cross-over designs could make an important contribution to the field of pharmacogenomics and that current research into the field of cross-over design has a rather distorted emphasis.

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Revised March 2002