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Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines

BACKGROUND: Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaborat...

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Autores principales: Ravinetto, Raffaella, De Nys, Katelijne, Boelaert, Marleen, Diro, Ermias, Meintjes, Graeme, Adoke, Yeka, Tagbor, Harry, Casteels, Minne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4696307/
https://www.ncbi.nlm.nih.gov/pubmed/26715307
http://dx.doi.org/10.1186/s12914-015-0073-8
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author Ravinetto, Raffaella
De Nys, Katelijne
Boelaert, Marleen
Diro, Ermias
Meintjes, Graeme
Adoke, Yeka
Tagbor, Harry
Casteels, Minne
author_facet Ravinetto, Raffaella
De Nys, Katelijne
Boelaert, Marleen
Diro, Ermias
Meintjes, Graeme
Adoke, Yeka
Tagbor, Harry
Casteels, Minne
author_sort Ravinetto, Raffaella
collection PubMed
description BACKGROUND: Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaboration with research partners, and is ultimately responsible for the trial’s scientific, ethical, regulatory and legal aspects, while another organization, generally in the North (the funder), provides the external funding and sets funding conditions. Even if external funding mechanisms are key for most non-commercial research, the dependence on an external funder’s policies may heavily influence the choices of a sponsor. In addition, the competition for accessing the available external funds is great, and non-commercial sponsors may not be in a position to discuss or refuse standard conditions set by a funder. To see whether the current definitions adequately address the intricacies of sponsorship in externally-funded trials, we looked at how a “sponsor” of clinical trials is defined in selected international guidelines, with particular focus on international Good Clinical Practices codes, and in selected European and African regulations/legislations. DISCUSSION: Our limited analysis suggests that the sponsors definition from the 1995 WHO Good Clinical Practices code has been integrated as such into many legislations, guidelines and regulations, and that it is not adequate to cover today’s reality of funding arrangements in global health, where the legal responsibility and the funding source are de facto split. In agreement with other groups, we suggest that the international Good Clinical Practices codes should be updated to reflect the reality of non-commercial clinical research. In particular, they should explicitly include the distinction between commercial and non-commercial sponsors, and provide guidance to non-commercial sponsors for negotiating with external funding agencies and other research counterparts. SUMMARY: Non-commercial sponsors of clinical trials should surely invest in the development of adequate legal, administrative and management skills. By acknowledging their role and specificities, and by providing them with adapted guidance, the international Good Clinical Practices codes would provide valuable guidance and support to non-commercial clinical research, whose relevance for global health is increasingly evident.
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spelling pubmed-46963072015-12-31 Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines Ravinetto, Raffaella De Nys, Katelijne Boelaert, Marleen Diro, Ermias Meintjes, Graeme Adoke, Yeka Tagbor, Harry Casteels, Minne BMC Int Health Hum Rights Debate BACKGROUND: Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaboration with research partners, and is ultimately responsible for the trial’s scientific, ethical, regulatory and legal aspects, while another organization, generally in the North (the funder), provides the external funding and sets funding conditions. Even if external funding mechanisms are key for most non-commercial research, the dependence on an external funder’s policies may heavily influence the choices of a sponsor. In addition, the competition for accessing the available external funds is great, and non-commercial sponsors may not be in a position to discuss or refuse standard conditions set by a funder. To see whether the current definitions adequately address the intricacies of sponsorship in externally-funded trials, we looked at how a “sponsor” of clinical trials is defined in selected international guidelines, with particular focus on international Good Clinical Practices codes, and in selected European and African regulations/legislations. DISCUSSION: Our limited analysis suggests that the sponsors definition from the 1995 WHO Good Clinical Practices code has been integrated as such into many legislations, guidelines and regulations, and that it is not adequate to cover today’s reality of funding arrangements in global health, where the legal responsibility and the funding source are de facto split. In agreement with other groups, we suggest that the international Good Clinical Practices codes should be updated to reflect the reality of non-commercial clinical research. In particular, they should explicitly include the distinction between commercial and non-commercial sponsors, and provide guidance to non-commercial sponsors for negotiating with external funding agencies and other research counterparts. SUMMARY: Non-commercial sponsors of clinical trials should surely invest in the development of adequate legal, administrative and management skills. By acknowledging their role and specificities, and by providing them with adapted guidance, the international Good Clinical Practices codes would provide valuable guidance and support to non-commercial clinical research, whose relevance for global health is increasingly evident. BioMed Central 2015-12-30 /pmc/articles/PMC4696307/ /pubmed/26715307 http://dx.doi.org/10.1186/s12914-015-0073-8 Text en © Ravinetto et al. 2015 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 Debate
Ravinetto, Raffaella
De Nys, Katelijne
Boelaert, Marleen
Diro, Ermias
Meintjes, Graeme
Adoke, Yeka
Tagbor, Harry
Casteels, Minne
Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines
title Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines
title_full Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines
title_fullStr Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines
title_full_unstemmed Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines
title_short Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines
title_sort sponsorship in non-commercial clinical trials: definitions, challenges and the role of good clinical practices guidelines
topic Debate
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4696307/
https://www.ncbi.nlm.nih.gov/pubmed/26715307
http://dx.doi.org/10.1186/s12914-015-0073-8
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