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Regulatory transparency: social, technical, and ethical aspects of clinical trial data access.

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Title: Regulatory transparency: social, technical, and ethical aspects of clinical trial data access.
Alternate Title: Transparencia reglamentaria: aspectos sociales, técnicos y éticos del acceso a los datos de los ensayos clínicos.
Authors: Dias Sousa, Varley1 varley.sousa@anvisa.gov.br, Silveira, Dâmaris2
Source: Pan American Journal of Public Health / Revista Panamericana de Salud Pública. Jun2015, Vol. 37 Issue 6, p430-434. 5p.
Subjects: CLINICAL trials, MEDICAL ethics, MEDICAL research, PRIVACY, RESEARCH ethics, GOVERNMENT policy, ACCESS to information, DATA security
Abstract (English): 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 data-sharing 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 interagency cooperation and collaboration initiatives that aim to harmonize health programs and regulatory convergence. [ABSTRACT FROM AUTHOR]
Abstract (Spanish): En el campo de la reglamentación sanitaria, la habilitación del acceso público a los datos de los ensayos clínicos constituye un proceso actualmente en fase de consolidación por parte de los principales reguladores a escala mundial. Este artículo trata sobre los recientes avances en las políticas públicas con respecto a la transparencia reglamentaria, y los riesgos y beneficios de un análisis reglamentario de la repercusión en los informes de los ensayos clínicos desde la perspectiva de los interesados directos clave (es decir, los pacientes, los prescriptores, el gobierno, la sociedad, la industria y los organismos reguladores). Por otra parte, se destacan los aspectos sociales, técnicos y éticos del proceso del uso compartido de datos, incluidos los límites de acceso, los datos comercialmente confidenciales y los derechos de patente, la privacidad de los sujetos sometidos a investigación, los acuerdos y las herramientas publicitarias, y el registro de los ensayos clínicos. Además, se muestran las perspectivas en materia de mejora y ampliación de las políticas de transparencia reglamentaria, contextualizando las experiencias norteamericanas, latinoamericanas y europeas, y destacando la cooperación interinstitucional y las iniciativas de colaboración dirigidas a la armonización de los programas de salud y a la convergencia reglamentaria. [ABSTRACT FROM AUTHOR]
Copyright of Pan American Journal of Public Health / Revista Panamericana de Salud Pública is the property of Pan American Health Organization and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: MedicLatina
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  Data: Regulatory transparency: social, technical, and ethical aspects of clinical trial data access.
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  Data: Transparencia reglamentaria: aspectos sociales, técnicos y éticos del acceso a los datos de los ensayos clínicos.
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  Data: <searchLink fieldCode="AR" term="%22Dias+Sousa%2C+Varley%22">Dias Sousa, Varley</searchLink><relatesTo>1</relatesTo><i> varley.sousa@anvisa.gov.br</i><br /><searchLink fieldCode="AR" term="%22Silveira%2C+Dâmaris%22">Silveira, Dâmaris</searchLink><relatesTo>2</relatesTo>
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  Data: <searchLink fieldCode="DE" term="%22CLINICAL+trials%22">CLINICAL trials</searchLink><br /><searchLink fieldCode="DE" term="%22MEDICAL+ethics%22">MEDICAL ethics</searchLink><br /><searchLink fieldCode="DE" term="%22MEDICAL+research%22">MEDICAL research</searchLink><br /><searchLink fieldCode="DE" term="%22PRIVACY%22">PRIVACY</searchLink><br /><searchLink fieldCode="DE" term="%22RESEARCH+ethics%22">RESEARCH ethics</searchLink><br /><searchLink fieldCode="DE" term="%22GOVERNMENT+policy%22">GOVERNMENT policy</searchLink><br /><searchLink fieldCode="DE" term="%22ACCESS+to+information%22">ACCESS to information</searchLink><br /><searchLink fieldCode="DE" term="%22DATA+security%22">DATA security</searchLink>
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  Data: 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 data-sharing 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 interagency cooperation and collaboration initiatives that aim to harmonize health programs and regulatory convergence. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label: Abstract (Spanish)
  Group: Ab
  Data: En el campo de la reglamentación sanitaria, la habilitación del acceso público a los datos de los ensayos clínicos constituye un proceso actualmente en fase de consolidación por parte de los principales reguladores a escala mundial. Este artículo trata sobre los recientes avances en las políticas públicas con respecto a la transparencia reglamentaria, y los riesgos y beneficios de un análisis reglamentario de la repercusión en los informes de los ensayos clínicos desde la perspectiva de los interesados directos clave (es decir, los pacientes, los prescriptores, el gobierno, la sociedad, la industria y los organismos reguladores). Por otra parte, se destacan los aspectos sociales, técnicos y éticos del proceso del uso compartido de datos, incluidos los límites de acceso, los datos comercialmente confidenciales y los derechos de patente, la privacidad de los sujetos sometidos a investigación, los acuerdos y las herramientas publicitarias, y el registro de los ensayos clínicos. Además, se muestran las perspectivas en materia de mejora y ampliación de las políticas de transparencia reglamentaria, contextualizando las experiencias norteamericanas, latinoamericanas y europeas, y destacando la cooperación interinstitucional y las iniciativas de colaboración dirigidas a la armonización de los programas de salud y a la convergencia reglamentaria. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of Pan American Journal of Public Health / Revista Panamericana de Salud Pública is the property of Pan American Health Organization and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=lth&AN=108846533
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      – Code: eng
        Text: English
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        PageCount: 5
        StartPage: 430
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      – SubjectFull: CLINICAL trials
        Type: general
      – SubjectFull: MEDICAL ethics
        Type: general
      – SubjectFull: MEDICAL research
        Type: general
      – SubjectFull: PRIVACY
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      – SubjectFull: RESEARCH ethics
        Type: general
      – SubjectFull: GOVERNMENT policy
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      – SubjectFull: ACCESS to information
        Type: general
      – SubjectFull: DATA security
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    Titles:
      – TitleFull: Regulatory transparency: social, technical, and ethical aspects of clinical trial data access.
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              M: 06
              Text: Jun2015
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              Y: 2015
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