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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.

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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; Whitehead, John; Oldham, Mary.

In: Journal of Biopharmaceutical Statistics, Vol. 18, No. 4, 07.2008, p. 737-749.

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Bolland, Kim ; Whitehead, John ; Oldham, Mary. / A safety monitoring procesure for a clinical drug development programme, with application to the accessment of a novel COX-2 inhibitor. In: Journal of Biopharmaceutical Statistics. 2008 ; Vol. 18, No. 4. pp. 737-749.

Bibtex

@article{b35e3d96b5ec43049a055d665b06abc4,
title = "A safety monitoring procesure for a clinical drug development programme, with application to the accessment of a novel COX-2 inhibitor.",
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.",
keywords = "Data and safety monitoring board, Drug development program, Interim analysis, Safety monitoring, Sequential design",
author = "Kim Bolland and John Whitehead and Mary Oldham",
year = "2008",
month = jul,
doi = "10.1080/10543400802071410",
language = "English",
volume = "18",
pages = "737--749",
journal = "Journal of Biopharmaceutical Statistics",
issn = "1054-3406",
publisher = "Taylor and Francis Ltd.",
number = "4",

}

RIS

TY - JOUR

T1 - A safety monitoring procesure for a clinical drug development programme, with application to the accessment of a novel COX-2 inhibitor.

AU - Bolland, Kim

AU - Whitehead, John

AU - Oldham, Mary

PY - 2008/7

Y1 - 2008/7

N2 - 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.

AB - 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.

KW - Data and safety monitoring board

KW - Drug development program

KW - Interim analysis

KW - Safety monitoring

KW - Sequential design

U2 - 10.1080/10543400802071410

DO - 10.1080/10543400802071410

M3 - Journal article

VL - 18

SP - 737

EP - 749

JO - Journal of Biopharmaceutical Statistics

JF - Journal of Biopharmaceutical Statistics

SN - 1054-3406

IS - 4

ER -