A note on penalty-free interim analyses of clinical studies with binary responses.

Full Abstract

In oncology studies with binary responses, it is often desirable to demonstrate the anti-tumor activity of a test drug before the planned study completes. We propose penalty-free interim analysis strategies that do not change the rejection criterion for the test of null hypothesis at the end. The strategies are applied to standard one-arm and two-arm studies. Although the motivating studies are from oncology, the findings in this research note are equally applicable to similar settings. A broad list of references is provide to stimulate further research on the topic.

Author information

Author/s: Chen, Cong (C);

Affiliation: Merck Research Laboratories, BL 3-2, PO Box 4, West Point, PA 19486, USA. Cong_chen(-atsign-)merck.com

Journal and publication information

Publication Type: Journal Article

Journal: Biometrical journal. Biometrische Zeitschrift (Biom J), published in Germany. (Language: eng)

Reference: 2005-Apr; vol 47 (issue 2) : pp 194-8

Dates: Created 2006/01/04; Completed 2006/01/25; Revised 2007/11/15;

PMID: 16389916, status: MEDLINE (last retrieval date: 2/18/2009, IMS Date: )

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