Current clinical research environment: focus on psychiatry
Autor(a) principal: | |
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Data de Publicação: | 2007 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Brazilian Journal of Psychiatry (São Paulo. 1999. Online) |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-44462007000300017 |
Resumo: | The introduction of international guidelines on Good Clinical Practices (GCP) in 1996, immediately followed by the publication of Resolution CNS 196/96 in Brazil, created a great opportunity for Brazilian research centers to participate in international trials. Such studies must be strictly monitored in order to assure compliance with the regulations, as well as with the standards of patient safety. Clear agreement among the investigator, the sponsor and the institution carrying out the study must be previously defined in order to avoid any conflicts of interest during or after the study. Operational aspects, such as the time needed to gain regulatory approval of the study design, strategies for patient recruitment/retention and appropriate logistics, are also important. In 2005, the Brazilian National Clinical Research Network was established, bringing together a number of research centers in teaching hospitals. The objective was to subsidize public clinical research with state-of-the-art practices and appropriate technical/scientific training programs. The development of research protocols that prioritize public health care needs in Brazil is other fundamental goal of this network. This article addresses general aspects of clinical research, as well as some specific issues in psychiatry. Improving the health and quality of life of the global population is certainly the major objective of all of the work done in this area. |
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Current clinical research environment: focus on psychiatryClinical researchRegulatory approvalConflict of interestPlaceboClinical trial registrationThe introduction of international guidelines on Good Clinical Practices (GCP) in 1996, immediately followed by the publication of Resolution CNS 196/96 in Brazil, created a great opportunity for Brazilian research centers to participate in international trials. Such studies must be strictly monitored in order to assure compliance with the regulations, as well as with the standards of patient safety. Clear agreement among the investigator, the sponsor and the institution carrying out the study must be previously defined in order to avoid any conflicts of interest during or after the study. Operational aspects, such as the time needed to gain regulatory approval of the study design, strategies for patient recruitment/retention and appropriate logistics, are also important. In 2005, the Brazilian National Clinical Research Network was established, bringing together a number of research centers in teaching hospitals. The objective was to subsidize public clinical research with state-of-the-art practices and appropriate technical/scientific training programs. The development of research protocols that prioritize public health care needs in Brazil is other fundamental goal of this network. This article addresses general aspects of clinical research, as well as some specific issues in psychiatry. Improving the health and quality of life of the global population is certainly the major objective of all of the work done in this area.Associação Brasileira de Psiquiatria2007-09-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-44462007000300017Brazilian Journal of Psychiatry v.29 n.3 2007reponame:Brazilian Journal of Psychiatry (São Paulo. 1999. Online)instname:Associação Brasileira de Psiquiatria (ABP)instacron:ABP10.1590/S1516-44462006005000049info:eu-repo/semantics/openAccessDainesi,Sonia MansoldoElkis,Helioeng2008-02-25T00:00:00Zoai:scielo:S1516-44462007000300017Revistahttp://www.bjp.org.br/ahead_of_print.asphttps://old.scielo.br/oai/scielo-oai.php||rbp@abpbrasil.org.br1809-452X1516-4446opendoar:2008-02-25T00:00Brazilian Journal of Psychiatry (São Paulo. 1999. Online) - Associação Brasileira de Psiquiatria (ABP)false |
dc.title.none.fl_str_mv |
Current clinical research environment: focus on psychiatry |
title |
Current clinical research environment: focus on psychiatry |
spellingShingle |
Current clinical research environment: focus on psychiatry Dainesi,Sonia Mansoldo Clinical research Regulatory approval Conflict of interest Placebo Clinical trial registration |
title_short |
Current clinical research environment: focus on psychiatry |
title_full |
Current clinical research environment: focus on psychiatry |
title_fullStr |
Current clinical research environment: focus on psychiatry |
title_full_unstemmed |
Current clinical research environment: focus on psychiatry |
title_sort |
Current clinical research environment: focus on psychiatry |
author |
Dainesi,Sonia Mansoldo |
author_facet |
Dainesi,Sonia Mansoldo Elkis,Helio |
author_role |
author |
author2 |
Elkis,Helio |
author2_role |
author |
dc.contributor.author.fl_str_mv |
Dainesi,Sonia Mansoldo Elkis,Helio |
dc.subject.por.fl_str_mv |
Clinical research Regulatory approval Conflict of interest Placebo Clinical trial registration |
topic |
Clinical research Regulatory approval Conflict of interest Placebo Clinical trial registration |
description |
The introduction of international guidelines on Good Clinical Practices (GCP) in 1996, immediately followed by the publication of Resolution CNS 196/96 in Brazil, created a great opportunity for Brazilian research centers to participate in international trials. Such studies must be strictly monitored in order to assure compliance with the regulations, as well as with the standards of patient safety. Clear agreement among the investigator, the sponsor and the institution carrying out the study must be previously defined in order to avoid any conflicts of interest during or after the study. Operational aspects, such as the time needed to gain regulatory approval of the study design, strategies for patient recruitment/retention and appropriate logistics, are also important. In 2005, the Brazilian National Clinical Research Network was established, bringing together a number of research centers in teaching hospitals. The objective was to subsidize public clinical research with state-of-the-art practices and appropriate technical/scientific training programs. The development of research protocols that prioritize public health care needs in Brazil is other fundamental goal of this network. This article addresses general aspects of clinical research, as well as some specific issues in psychiatry. Improving the health and quality of life of the global population is certainly the major objective of all of the work done in this area. |
publishDate |
2007 |
dc.date.none.fl_str_mv |
2007-09-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-44462007000300017 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-44462007000300017 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.1590/S1516-44462006005000049 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Associação Brasileira de Psiquiatria |
publisher.none.fl_str_mv |
Associação Brasileira de Psiquiatria |
dc.source.none.fl_str_mv |
Brazilian Journal of Psychiatry v.29 n.3 2007 reponame:Brazilian Journal of Psychiatry (São Paulo. 1999. Online) instname:Associação Brasileira de Psiquiatria (ABP) instacron:ABP |
instname_str |
Associação Brasileira de Psiquiatria (ABP) |
instacron_str |
ABP |
institution |
ABP |
reponame_str |
Brazilian Journal of Psychiatry (São Paulo. 1999. Online) |
collection |
Brazilian Journal of Psychiatry (São Paulo. 1999. Online) |
repository.name.fl_str_mv |
Brazilian Journal of Psychiatry (São Paulo. 1999. Online) - Associação Brasileira de Psiquiatria (ABP) |
repository.mail.fl_str_mv |
||rbp@abpbrasil.org.br |
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1754212553814179840 |