A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

Research output: Contribution to journalArticle

Carol M. Ashton, Nelda Wray, Anna F. Jarman, Jacob M. Kolman, Danielle M. Wenner, Baruch A. Brody

Background: If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods: The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings: Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions: The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.

Original languageEnglish (US)
Pages (from-to)368-373
Number of pages6
JournalJournal of Medical Ethics
Volume37
Issue number6
DOIs
StatePublished - Jun 1 2011

PMID: 21429960

PMCID: PMC3571710

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A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions. / Ashton, Carol M.; Wray, Nelda; Jarman, Anna F.; Kolman, Jacob M.; Wenner, Danielle M.; Brody, Baruch A.

In: Journal of Medical Ethics, Vol. 37, No. 6, 01.06.2011, p. 368-373.

Research output: Contribution to journalArticle

Harvard

Ashton, CM, Wray, N, Jarman, AF, Kolman, JM, Wenner, DM & Brody, BA 2011, 'A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions' Journal of Medical Ethics, vol. 37, no. 6, pp. 368-373. https://doi.org/10.1136/jme.2010.039255

APA

Ashton, C. M., Wray, N., Jarman, A. F., Kolman, J. M., Wenner, D. M., & Brody, B. A. (2011). A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions. Journal of Medical Ethics, 37(6), 368-373. https://doi.org/10.1136/jme.2010.039255

Vancouver

Ashton CM, Wray N, Jarman AF, Kolman JM, Wenner DM, Brody BA. A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions. Journal of Medical Ethics. 2011 Jun 1;37(6):368-373. https://doi.org/10.1136/jme.2010.039255

Author

Ashton, Carol M. ; Wray, Nelda ; Jarman, Anna F. ; Kolman, Jacob M. ; Wenner, Danielle M. ; Brody, Baruch A. / A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions. In: Journal of Medical Ethics. 2011 ; Vol. 37, No. 6. pp. 368-373.

BibTeX

@article{f36a23d054624ecaa25df1f30e065647,
title = "A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions",
abstract = "Background: If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods: The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5{\%} sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings: Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions: The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.",
author = "Ashton, {Carol M.} and Nelda Wray and Jarman, {Anna F.} and Kolman, {Jacob M.} and Wenner, {Danielle M.} and Brody, {Baruch A.}",
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RIS

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T1 - A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

AU - Ashton, Carol M.

AU - Wray, Nelda

AU - Jarman, Anna F.

AU - Kolman, Jacob M.

AU - Wenner, Danielle M.

AU - Brody, Baruch A.

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N2 - Background: If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods: The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings: Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions: The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.

AB - Background: If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods: The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings: Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions: The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.

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