Regulatory transparency: social, technical, and ethical aspects of clinical trial data access
In the field of health regulation, enabling public access to data from clinical trials is a process currently undergoing consolidation by the principal regulators worldwide. This paper discusses recent developments in public policy regarding regulatory transparency, and the risks and benefits of a r...
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ftdoajarticles:oai:doaj.org/article:4ec48ecbd6c84ba0ad9fdd0195656e45 2023-05-15T15:04:36+02:00 Regulatory transparency: social, technical, and ethical aspects of clinical trial data access Varley Dias Sousa Dâmaris Silveira 2015-06-01T00:00:00Z https://doaj.org/article/4ec48ecbd6c84ba0ad9fdd0195656e45 EN ES PT eng spa por Pan American Health Organization http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892015000500009&lng=en&tlng=en https://doaj.org/toc/1020-4989 1020-4989 https://doaj.org/article/4ec48ecbd6c84ba0ad9fdd0195656e45 Revista Panamericana de Salud Pública, Vol 37, Iss 6, Pp 430-434 (2015) ensayos clínicos como asunto revelación confidencialidad privacidad acceso a la información política de salud Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2015 ftdoajarticles 2022-12-31T06:11:29Z In the field of health regulation, enabling public access to data from clinical trials is a process currently undergoing consolidation by the principal regulators worldwide. This paper discusses recent developments in public policy regarding regulatory transparency, and the risks and benefits of a regulatory impact-analysis on clinical trial reports, from the perspective of the key stakeholders (i.e., patients, prescribers, government, society, industry, and regulators). Additionally, the social, technical, and ethical aspects of the datasharing process are highlighted, including access limits, commercially-confidential data and patent rights, privacy of research subjects, arrangements and publicity tools, and clinical trials registration. Furthermore, perspectives on improvement and expansion of regulatory transparency policies are presented, contextualizing North American, Latin American, and European experiences, and highlighting in-teragency cooperation and collaboration initiatives that aim to harmonize health programs and regulatory convergence. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic |
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Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English Spanish Portuguese |
topic |
ensayos clínicos como asunto revelación confidencialidad privacidad acceso a la información política de salud Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
ensayos clínicos como asunto revelación confidencialidad privacidad acceso a la información política de salud Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Varley Dias Sousa Dâmaris Silveira Regulatory transparency: social, technical, and ethical aspects of clinical trial data access |
topic_facet |
ensayos clínicos como asunto revelación confidencialidad privacidad acceso a la información política de salud Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
In the field of health regulation, enabling public access to data from clinical trials is a process currently undergoing consolidation by the principal regulators worldwide. This paper discusses recent developments in public policy regarding regulatory transparency, and the risks and benefits of a regulatory impact-analysis on clinical trial reports, from the perspective of the key stakeholders (i.e., patients, prescribers, government, society, industry, and regulators). Additionally, the social, technical, and ethical aspects of the datasharing process are highlighted, including access limits, commercially-confidential data and patent rights, privacy of research subjects, arrangements and publicity tools, and clinical trials registration. Furthermore, perspectives on improvement and expansion of regulatory transparency policies are presented, contextualizing North American, Latin American, and European experiences, and highlighting in-teragency cooperation and collaboration initiatives that aim to harmonize health programs and regulatory convergence. |
format |
Article in Journal/Newspaper |
author |
Varley Dias Sousa Dâmaris Silveira |
author_facet |
Varley Dias Sousa Dâmaris Silveira |
author_sort |
Varley Dias Sousa |
title |
Regulatory transparency: social, technical, and ethical aspects of clinical trial data access |
title_short |
Regulatory transparency: social, technical, and ethical aspects of clinical trial data access |
title_full |
Regulatory transparency: social, technical, and ethical aspects of clinical trial data access |
title_fullStr |
Regulatory transparency: social, technical, and ethical aspects of clinical trial data access |
title_full_unstemmed |
Regulatory transparency: social, technical, and ethical aspects of clinical trial data access |
title_sort |
regulatory transparency: social, technical, and ethical aspects of clinical trial data access |
publisher |
Pan American Health Organization |
publishDate |
2015 |
url |
https://doaj.org/article/4ec48ecbd6c84ba0ad9fdd0195656e45 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Revista Panamericana de Salud Pública, Vol 37, Iss 6, Pp 430-434 (2015) |
op_relation |
http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892015000500009&lng=en&tlng=en https://doaj.org/toc/1020-4989 1020-4989 https://doaj.org/article/4ec48ecbd6c84ba0ad9fdd0195656e45 |
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1766336339451576320 |