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Commentary: considerations for using the ‘Trials within Cohorts’ design in a clinical trial of an investigational medicinal product
BACKGROUND: The ‘trials within cohorts’ (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. MAIN TE...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5759253/ https://www.ncbi.nlm.nih.gov/pubmed/29310706 http://dx.doi.org/10.1186/s13063-017-2432-3 |
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author | Bibby, Anna C. Torgerson, David J. Leach, Samantha Lewis-White, Helen Maskell, Nick A. |
author_facet | Bibby, Anna C. Torgerson, David J. Leach, Samantha Lewis-White, Helen Maskell, Nick A. |
author_sort | Bibby, Anna C. |
collection | PubMed |
description | BACKGROUND: The ‘trials within cohorts’ (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. MAIN TEXT: To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. CONCLUSION: We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2432-3) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5759253 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-57592532018-01-10 Commentary: considerations for using the ‘Trials within Cohorts’ design in a clinical trial of an investigational medicinal product Bibby, Anna C. Torgerson, David J. Leach, Samantha Lewis-White, Helen Maskell, Nick A. Trials Commentary BACKGROUND: The ‘trials within cohorts’ (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. MAIN TEXT: To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. CONCLUSION: We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2432-3) contains supplementary material, which is available to authorized users. BioMed Central 2018-01-08 /pmc/articles/PMC5759253/ /pubmed/29310706 http://dx.doi.org/10.1186/s13063-017-2432-3 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Commentary Bibby, Anna C. Torgerson, David J. Leach, Samantha Lewis-White, Helen Maskell, Nick A. Commentary: considerations for using the ‘Trials within Cohorts’ design in a clinical trial of an investigational medicinal product |
title | Commentary: considerations for using the ‘Trials within Cohorts’ design in a clinical trial of an investigational medicinal product |
title_full | Commentary: considerations for using the ‘Trials within Cohorts’ design in a clinical trial of an investigational medicinal product |
title_fullStr | Commentary: considerations for using the ‘Trials within Cohorts’ design in a clinical trial of an investigational medicinal product |
title_full_unstemmed | Commentary: considerations for using the ‘Trials within Cohorts’ design in a clinical trial of an investigational medicinal product |
title_short | Commentary: considerations for using the ‘Trials within Cohorts’ design in a clinical trial of an investigational medicinal product |
title_sort | commentary: considerations for using the ‘trials within cohorts’ design in a clinical trial of an investigational medicinal product |
topic | Commentary |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5759253/ https://www.ncbi.nlm.nih.gov/pubmed/29310706 http://dx.doi.org/10.1186/s13063-017-2432-3 |
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