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A safety monitoring procesure for a clinical drug development programme, with application to the accessment of a novel COX-2 inhibitor.

Bolland, Kim and Whitehead, John and Oldham, Mary (2008) A safety monitoring procesure for a clinical drug development programme, with application to the accessment of a novel COX-2 inhibitor. Journal of Biopharmaceutical Statistics, 18 (4). pp. 737-749. ISSN 1520-5711

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Abstract

Formal safety monitoring procedures are well-developed for use in individual clinical trials and provide valuable guidance to Independent Data Monitoring Committees (IDMCs). Less has been written about procedures for use over the whole of a drug development program. It is becoming common for a single IDMC to be appointed for a whole series of studies involving a single compound. While each study will have its own goals in terms of efficacy, safety, or both, there is the potential for all of them to contribute to an emerging picture of safety. Indeed, an IDMC overseeing several studies will need to integrate the data coming from each and a formal pre-defined approach can be a valuable aid. Formal procedures are especially relevant in situations where one or two undesirable events are recognized from the outset as being of particular concern. In some cases this might be death, and in the example discussed here it is a cardiovascular event of the type that has been found to be related to certain COX-2 inhibitors. In this paper a design proposal for a safety monitoring procedure for use by an IDMC during the development of a new COX-2 inhibitor will be described.

Item Type: Article
Journal or Publication Title: Journal of Biopharmaceutical Statistics
Uncontrolled Keywords: Data and safety monitoring board ; Drug development program ; Interim analysis ; Safety monitoring ; Sequential design
Subjects: Q Science > QA Mathematics
Departments: Faculty of Science and Technology > Mathematics and Statistics
ID Code: 26957
Deposited By: Mr Richard Ingham
Deposited On: 19 Aug 2009 11:05
Refereed?: Yes
Published?: Published
Last Modified: 09 Oct 2013 14:49
Identification Number:
URI: http://eprints.lancs.ac.uk/id/eprint/26957

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