JSM 2004 Online Program

Abstract #301636

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Activity Number:	29
Type:	Contributed
Date/Time:	Sunday, August 8, 2004 : 2:00 PM to 3:50 PM
Sponsor:	Biopharmaceutical Section
Abstract - #301636
Title:	Impact on Error Rates When Futility Criteria is Based on Secondary Endpoint
Author(s):	Akiko Okamoto*+ and Yi-wen Ma and Surya Mohanty
Companies:	Johnson & Johnson Pharmaceutical R&D, LLC and Johnson & Johnson Pharmaceutical R&D, LLC and Johnson & Johnson Pharmaceutical R&D, LLC
Address:	1125 Trenton-Harbourton Rd., Titusville, NJ, 08560,
Keywords:	futility ; interim analysis ; error rate
Abstract:	Decision to curtail a clinical trial may need to be based on an endpoint other than the primary endpoint. These decision rules will have an impact on the error rate. These rates will be some function of the dependence between the primary endpoint and the decision-making endpoint. The same concept could be extended to a multi-arm trial in curtailing some of the ineffective arms. The operating characteristics for such situations under various relationships between primary endpoint and decision-making endpoint will be discussed.

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