Hegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countries
This article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A to...
- Autores:
-
Ovalle, Constanza E.
- Tipo de recurso:
- Article of journal
- Fecha de publicación:
- 2021
- Institución:
- Universidad El Bosque
- Repositorio:
- Repositorio U. El Bosque
- Idioma:
- eng
- OAI Identifier:
- oai:repositorio.unbosque.edu.co:20.500.12495/7141
- Palabra clave:
- Bioethics
Clinical trials
Developing world bioethics
Drug trial
Low-income population
Placebo
- Rights
- openAccess
- License
- Acceso abierto
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dc.title.spa.fl_str_mv |
Hegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countries |
dc.title.translated.spa.fl_str_mv |
Hegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countries |
title |
Hegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countries |
spellingShingle |
Hegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countries Bioethics Clinical trials Developing world bioethics Drug trial Low-income population Placebo |
title_short |
Hegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countries |
title_full |
Hegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countries |
title_fullStr |
Hegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countries |
title_full_unstemmed |
Hegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countries |
title_sort |
Hegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countries |
dc.creator.fl_str_mv |
Ovalle, Constanza E. |
dc.contributor.author.none.fl_str_mv |
Ovalle, Constanza E. |
dc.contributor.orcid.none.fl_str_mv |
Ardila, Carlos Martín [https://orcid.org/0000-0002-3663-1416] |
dc.subject.keywords.spa.fl_str_mv |
Bioethics Clinical trials Developing world bioethics Drug trial Low-income population Placebo |
topic |
Bioethics Clinical trials Developing world bioethics Drug trial Low-income population Placebo |
description |
This article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A total of 53% of the CTs reviewed were performed in low- and middle-income (LMI) countries, and 92% used a control/placebo group as a comparison group. Although there is a gold standard for the adjunctive treatment of periodontitis, the research ethics committees of most of the analyzed studies approved the use of control/placebo groups for the performance of CTs that did not explore new therapeutic alternatives. In some cases, the CT protocols were not approved by ethics committees, nor was informed consent used. In the LMI countries, a shorter period of recruitment was observed for patients who attended universities and public hospitals. Likewise, most of the CTs reviewed had public funding, a significant amount of which came from the pharmaceutical industry. Only one CT reported the low economic and educational level of its participants. Furthermore, none of the authors of the reviewed CTs declared conflicts of interest. Although the axiology of techno-science always takes into account at least the epistemic, technical and economic value systems, the hegemony of the economic values imposed by the pharmaceutical industry is evident in the performance of CTs investigating the treatment of periodontitis in LMI countries. |
publishDate |
2021 |
dc.date.issued.none.fl_str_mv |
2021 |
dc.date.accessioned.none.fl_str_mv |
2022-03-05T20:10:55Z |
dc.date.available.none.fl_str_mv |
2022-03-05T20:10:55Z |
dc.type.coar.fl_str_mv |
http://purl.org/coar/resource_type/c_2df8fbb1 |
dc.type.local.none.fl_str_mv |
Artículo de revista |
dc.type.hasversion.none.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.coar.none.fl_str_mv |
http://purl.org/coar/resource_type/c_6501 |
dc.type.driver.none.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.coarversion.none.fl_str_mv |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
format |
http://purl.org/coar/resource_type/c_6501 |
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publishedVersion |
dc.identifier.issn.none.fl_str_mv |
1471-8731 |
dc.identifier.uri.none.fl_str_mv |
http://hdl.handle.net/20.500.12495/7141 |
dc.identifier.doi.none.fl_str_mv |
https://doi.org/10.1111/dewb.12334 |
dc.identifier.instname.spa.fl_str_mv |
instname:Universidad El Bosque |
dc.identifier.reponame.spa.fl_str_mv |
reponame:Repositorio Institucional Universidad El Bosque |
dc.identifier.repourl.none.fl_str_mv |
repourl:https://repositorio.unbosque.edu.co |
identifier_str_mv |
1471-8731 instname:Universidad El Bosque reponame:Repositorio Institucional Universidad El Bosque repourl:https://repositorio.unbosque.edu.co |
url |
http://hdl.handle.net/20.500.12495/7141 https://doi.org/10.1111/dewb.12334 |
dc.language.iso.none.fl_str_mv |
eng |
language |
eng |
dc.relation.ispartofseries.spa.fl_str_mv |
Developing World Bioethics, 1471-8731, 2021 |
dc.relation.uri.none.fl_str_mv |
https://onlinelibrary.wiley.com/doi/abs/10.1111/dewb.12334 |
dc.rights.local.spa.fl_str_mv |
Acceso abierto |
dc.rights.accessrights.none.fl_str_mv |
http://purl.org/coar/access_right/c_abf2 info:eu-repo/semantics/openAccess Acceso abierto |
rights_invalid_str_mv |
Acceso abierto http://purl.org/coar/access_right/c_abf2 |
eu_rights_str_mv |
openAccess |
dc.format.mimetype.none.fl_str_mv |
application/pdf |
dc.publisher.spa.fl_str_mv |
John Wiley and Sons Inc |
dc.publisher.journal.spa.fl_str_mv |
Developing World Bioethics |
institution |
Universidad El Bosque |
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spelling |
Ovalle, Constanza E.Ardila, Carlos Martín [https://orcid.org/0000-0002-3663-1416]2022-03-05T20:10:55Z2022-03-05T20:10:55Z20211471-8731http://hdl.handle.net/20.500.12495/7141https://doi.org/10.1111/dewb.12334instname:Universidad El Bosquereponame:Repositorio Institucional Universidad El Bosquerepourl:https://repositorio.unbosque.edu.coapplication/pdfengJohn Wiley and Sons IncDeveloping World BioethicsDeveloping World Bioethics, 1471-8731, 2021https://onlinelibrary.wiley.com/doi/abs/10.1111/dewb.12334Hegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countriesHegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countriesArtículo de revistainfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501http://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articlehttp://purl.org/coar/version/c_970fb48d4fbd8a85BioethicsClinical trialsDeveloping world bioethicsDrug trialLow-income populationPlaceboThis article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A total of 53% of the CTs reviewed were performed in low- and middle-income (LMI) countries, and 92% used a control/placebo group as a comparison group. Although there is a gold standard for the adjunctive treatment of periodontitis, the research ethics committees of most of the analyzed studies approved the use of control/placebo groups for the performance of CTs that did not explore new therapeutic alternatives. In some cases, the CT protocols were not approved by ethics committees, nor was informed consent used. In the LMI countries, a shorter period of recruitment was observed for patients who attended universities and public hospitals. Likewise, most of the CTs reviewed had public funding, a significant amount of which came from the pharmaceutical industry. Only one CT reported the low economic and educational level of its participants. Furthermore, none of the authors of the reviewed CTs declared conflicts of interest. Although the axiology of techno-science always takes into account at least the epistemic, technical and economic value systems, the hegemony of the economic values imposed by the pharmaceutical industry is evident in the performance of CTs investigating the treatment of periodontitis in LMI countries.Acceso abiertohttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessAcceso abiertoORIGINALArchivo en blanco.txtArchivo en blanco.txtHegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countriestext/plain16https://repositorio.unbosque.edu.co/bitstreams/d34ca46d-0e6c-4bb0-adcb-5815a7ae394f/download394676c3389aaeaf019c6d45a11b77e9MD51LICENSElicense.txtlicense.txttext/plain; charset=utf-81748https://repositorio.unbosque.edu.co/bitstreams/0aa176f6-8771-4a41-864a-aeee0a6235ab/download8a4605be74aa9ea9d79846c1fba20a33MD52TEXTArchivo en blanco.txt.txtArchivo en blanco.txt.txtExtracted texttext/plain17https://repositorio.unbosque.edu.co/bitstreams/b257b094-b687-417b-b500-4182e0590104/download56c6ce8af9aa607a4926da6a3e88d080MD5320.500.12495/7141oai:repositorio.unbosque.edu.co:20.500.12495/71412024-02-07 08:28:33.178open.accesshttps://repositorio.unbosque.edu.coRepositorio Institucional Universidad El Bosquebibliotecas@biteca.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 |