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1. Review of regulation of biological and biotechnological products inLatin American and Caribbean countries. ok

Autor(es): Pombo ML; Di Fabio JL; Cortes Mde LFonte:Biologicals; 37(5): 271-6, 2009 Oct.

Artigo [MEDLINE PMID: 19664935 ] Idioma: InglsTipo de publicao: Artigo de Revista; RevisoThe regulation of the biological and biotechnological products constitutes a significantchallenge, since they are part of a sector of the pharmaceutical industry that is currentlyexperiencing rapid growth. Unlike conventional medicines, the manufacture of these

products involves the use of living organisms and processes that impede manufacturingconsistency. Even though there are numerous international reference documents relatedto biotechnological product regulation, there is no consensus by official entities that areconsidered reference institutions, with regard to the most important definitions used andthe mechanisms for product regulation. The Pan-American Health Organization(PAHO), through the Technology, Health Care and Research Area, has developed aseries of activities that are described in this document. The objective of this publicationis to present the current picture of biotechnological and biological product regulation inthe Latin American and Caribbean Region, in order to offer guidance that will facilitatethe regulation of these products in a harmonized manner among the countries of theMember States, as well as responding to the request from some regulatory agencies toaddress the growing demand for licensing applications of these products.Assunto(s):Produtos Biolgicos/uso teraputicoBiotecnologia/legislao &

jurisprudnciaPesquisa Biomdica/legislao & jurisprudnciaRegio do CaribeColeta de DadosPoltica de Sade/legislao & jurisprudnciaPesquisa sobre Serviosde Sade/legislao & jurisprudnciaHumanosAmrica LatinaOrganizao Pan-

Americana da Sade/organizao & administrao

2. Research contribution of different world regions in the top 50biomedical journals (1995-2002). ok

Autor(es): Soteriades ES; Rosmarakis ES; Paraschakis K; Falagas MEFonte:FASEB J; 20(1): 29-34, 2006 Jan.

Artigo [MEDLINE PMID: 16394264 ] Idioma: InglsTipo de publicao: Estudo Comparativo; Artigo de RevistaWe evaluated all articles published by different world regions in the top 50 biomedical

journals in the database of the Journal Citation Reports-Institute for ScientificInformation for the period between 1995 and 2002. The world was divided into 9regions [United States of America (the U.S.), Western Europe, Japan, Canada, Asia,Oceania, Latin America, and the Caribbean, Eastern Europe, and Africa] based on acombination of geographic, economic and scientific criteria. The number of articles

published by each region, the mean impact factor, and the product of the above twoparameters were our main indicators. The above numbers were also adjusted forpopulation size, gross national income per capita of each region, and other factors.Articles published from the U.S. made up about two-thirds of all scientific papers

published in the top 50 biomedical journals between 1995 and 2002. Western Europe

contributed approximately a quarter of the published papers while the remaining one-tenth of articles came from the rest of the world. Canada, however, ranked second when
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number of articles was adjusted for population size. The U.S. is by far the highest-ranking country/region in publications in the top 50 biomedical journals even afteradjusting for population size, gross national product, and other factors. Canada andWestern Europe share the second place while the rest of the world is far behind.Assunto(s):Pesquisa Biomdica/estatstica & dados numricosPublicaes Peridicas

como Assunto/estatstica & dados numricosfricasiaPesquisa Biomdica/economiaCanadRegio do CaribeAmrica CentralEuropa (Continente)InternacionalidadeAmrica LatinaOceaniaDensidade DemogrficaFatores de TempoEstados Unidos

3. Health research in Latin America. okAutor(es): Becerra F; Cuervo LGFonte:Lancet; 375(9709): 120, 2010 Jan 9.

Artigo [MEDLINE PMID: 20109887 ] Idioma: InglsTipo de publicao: Comentrio; CartaAssunto(s):Pesquisa BiomdicaPoltica de SadeCongressos como AssuntoHumanosAmrica LatinaApoio Pesquisa como Assunto

4. Cross-sector learning among researchers and policy-makers: thesearch for new strategies to enable use of research results. ok

Autor(es): Pittman P; Almeida CFonte:Cad Saude Publica; 22 Suppl: S97-108, 2006.

Artigo [MEDLINE PMID: 17086343 ] Idioma: Ingls

Tipo de publicao: Artigo de RevistaThis paper assesses the preliminary results of a research funding strategy that alters thestructure and process of research by requiring interaction between researchers and

policy-makers. The five research teams focused on different aspects of expanding socialprotection in health in Latin America and the Caribbean. Preliminary results revealednegotiation of the research questions at the start of the process, influencing not only the

project design, but the decision-makers' ways of thinking about the problem as well. Asthe projects advanced, turnover among government officials on four of the teamsimpaired the process. However, for the one team that escaped re-composition, theinteraction has led to use of data in decision-making, as well as a clear recognition by

both parties that different kinds of evidence were at play. The process highlighted theimportance of stimulating systems of learning in which multiple kinds of knowledgeinteract. This interaction may be a more realistic expectation of such initiatives than theoriginal goal of [quot ]transferring[quot ] research knowledge to policy and practice.Assunto(s):Pessoal AdministrativoPesquisa Biomdica/economiaTomada de DecisesRelaes InterprofissionaisFormulao de PolticasPesquisadoresRegio do CaribeFinanciamento GovernamentalConhecimentos, Atitudes e Prtica em SadePesquisasobre Servios de SadeHumanosCooperao InternacionalAmrica LatinaOrganizao Pan-Americana da SadeProjetos de PesquisaApoio Pesquisa comoAssunto/organizao & administrao
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5. Latin America faces hurdles in health research. okAutor(es): Moloney AFonte:Lancet; 374(9695): 1053-4, 2009 Sep 26.


Tipo de publicao: NotciasAssunto(s):Pesquisa Biomdica/economiaApoio Pesquisa como AssuntoAmricaLatina

6. Research priorities for neglected infectious diseases in LatinAmerica and the Caribbean region. ok

Autor(es): Dujardin JC; Herrera S; do Rosario V; Arevalo J; Boelaert M; Carrasco HJ;Correa-Oliveira R; Garcia L; Gotuzzo E; Gyorkos TW; Kalergis AM; Kouri G; Larraga

V; Lutumba P; Macias Garcia MA; Manrique-Saide PC; Modabber F; Nieto A;Pluschke G; Robello C; Rojas de Arias A; Rumbo M; Santos Preciado JI; Sundar S;Torres J; Torrico F; Van der Stuyft P; Victoir K; Olesen OFFonte:PLoS Negl Trop Dis; 4(10): e780, 2010.

Artigo [MEDLINE PMID: 21049009 ] Idioma: InglsTipo de publicao: Artigo de Revista; Research Support, Non-U.S. Gov't; RevisoAssunto(s):Pesquisa Biomdica/tendnciasDoenas Transmissveis/epidemiologiaDoenas Negligenciadas/epidemiologiaPesquisaRegio do Caribe/epidemiologiaDoenas Transmissveis/diagnsticoDoenas Transmissveis/quimioterapiaHumanosAmrica Latina/epidemiologiaDoenas Negligenciadas/diagnsticoDoenas

Negligenciadas/quimioterapiaDoenas Negligenciadas/preveno & controle

7. Clinical Research in Emerging Countries--Third Annual MarcusEvans Conference.

Autor(es): Singh SFonte:IDrugs; 11(10): 724-7, 2008 Oct.

Artigo [MEDLINE PMID: 18828071 ] Idioma: InglsTipo de publicao: CongressosAssunto(s):Pesquisa BiomdicaEnsaios Clnicos como AssuntoPases em

DesenvolvimentoServios TerceirizadosProjetos de PesquisafricaPesquisaBiomdica/economiaPesquisa Biomdica/legislao & jurisprudnciaPesquisaBiomdica/organizao & administraoChinaEnsaios Clnicos comoAssunto/economiaEnsaios Clnicos como Assunto/legislao & jurisprudnciaIndstria FarmacuticaRegulamentao GovernamentalFidelidade a DiretrizesGuiascomo AssuntoHumanosndiaCooperao InternacionalJapoAmrica LatinaSeleode PacientesProjetos de Pesquisa/legislao & jurisprudnciaApoio Pesquisa comoAssuntoFederao RussaTamanho da Amostra

8. Mexican billionaire invests millions in Latin American health. okFonte:Bull World Health Organ; 85(8): 574-5, 2007 Aug.
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Artigo [MEDLINE PMID: 17768511 ] Idioma: InglsTipo de publicao: NotciasAssunto(s):Academias e Institutos/economiaFundaes/economiaPrioridades emSade/economiaAcesso aos Servios de Sade/organizao & administraoAcademias e Institutos/organizao & administraoPesquisa Biomdica/organizao

& administraoPases em DesenvolvimentoFundaes/organizao & administraoPrioridades em Sade/organizao & administraoHumanosAmrica LatinaMxico

9. Publicaciones biomdicas: realidad de Chile y Latinoamrica/Biomedical publications: Chilean and Latin American reality ok

Glvez M, MarceloRev. chil. radiol; 12(3): 113-117, 2006. tab, grafArtigo [LILACS ID: lil-453337 ] Idioma: Espanhol

10.Health research and developing nations. NoBloom BRHastings Cent Rep; 6(6): 9-12, 1976 Dec.Artigo [MEDLINE PMID: 993018 ] Idioma: Ingls

11.Trends in the publication of scientific research in travel medicinefrom Latin America. ok

Rodriguez-Morales AJ; Palacios HTravel Med Infect Dis; 7(5): 323-4, 2009 Sep.Artigo [MEDLINE PMID: 19747671 ] Idioma: Ingls

12.Which are the leading countries in clinical medicine research? Acitation analysis (1981-1998). ok

Fava GA; Ottolini F; Sonino N

Psychother Psychosom; 70(6): 283-7, 2001 Nov-Dec.Artigo [MEDLINE PMID: 11598427 ] Idioma: Ingls

13.Latin American network promotes translational research. okOrellana CLancet Oncol; 4(9): 523, 2003 Sep.Artigo [MEDLINE PMID: 12965281 ] Idioma: Ingls
http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/mdl-17768511http://pesquisa.bvsalud.org/regional/resources/lil-453337http://pesquisa.bvsalud.org/regional/resources/lil-453337http://pesquisa.bvsalud.org/regional/resources/lil-453337http://pesquisa.bvsalud.org/regional/resources/lil-453337http://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=Rev.%20chil.%20radiolhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=Rev.%20chil.%20radiolhttp://pesquisa.bvsalud.org/regional/resources/mdl-993018http://pesquisa.bvsalud.org/regional/resources/mdl-993018http://pesquisa.bvsalud.org/regional/resources/mdl-993018http://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=Hastings%20Cent%20Rephttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=Hastings%20Cent%20Rephttp://pesquisa.bvsalud.org/regional/resources/mdl-19747671http://pesquisa.bvsalud.org/regional/resources/mdl-19747671http://pesquisa.bvsalud.org/regional/resources/mdl-19747671http://pesquisa.bvsalud.org/regional/resources/mdl-19747671http://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=Travel%20Med%20Infect%20Dishttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=Travel%20Med%20Infect%20Dishttp://pesquisa.bvsalud.org/regional/resources/mdl-11598427http://pesquisa.bvsalud.org/regional/resources/mdl-11598427http://pesquisa.bvsalud.org/regional/resources/mdl-11598427http://pesquisa.bvsalud.org/regional/resources/mdl-11598427http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14.Science at a Crossroads: Advancing Biomedical Research in LatinAmerica

Autor(es): Pew Latin American Fellows Program; Jennifer Y. Ruzek; Rusten,NonaKocher; Montano de Jimnez, H. Cheryl Silvia; O Neil, Edward H.

[LIS ID: LISBR1.1-10389 ] Idioma: InglsThe report begins with a summary history of biomedical research in the region. Adetailed account follows of current government, foundation and private industryfunding, which provides context for understanding the regional challenges that lieahead. Next, the report summarizes the Pew alumni survey to reveal scientiststhoughts about programmatic progress and future challenges. The report concludes witha set of recommendations that address long- and shortterm challenges. (Au)Assunto(s):PolititicaTendenciasPesquisa BiomdicaIndicadoresIndicadoresAmericaLatina

Clinical trial american latin

15.Clinical research and drug development in Latin America:weighing the pros and cons, talking about the future.

Autor(es): Rodrigues DG

Fonte:J Investig Med; 55(5): 223-9, 2007 Jul.


Tipo de publicao: Artigo de Revista

Two decades ago, clinical trials were carried out only in developed countries. Drug

development and the need to speed up clinical trials lead the conduction of clinical trials to

other countries. Among the regions of interest, Latin America (LA) has played its role

successfully. LA has a large number of naive patients, qualified investigators, established

regulatory systems and reasonable costs. Furthermore, LA might be also considered as a new

option for any company looking for international patterns on drug research and development.

The region has good professionals with scientific qualifications, well-established multinational

pharmaceutical bases and an expansive pharmaceutical regional market. This work

summarizes the recent advances that have occurred in drug research and development in the

region and the expansion of the clinical trial market in the last couple of years.

16.The Latin American Ongoing Clinical Trial Register (LATINREC)ok

Autor(es): Reveiz, Ludovic; Delgado, Martha B; Urrutia, Gerard; Ortiz, Zulma; Garcia Dieguez,

Marcelo; Mart-Carvajal, Arturo; Calgua, Erwin; Vieyra, Armando; Ciapponi, Agustn; Hidalgo,

Ricardo; Pantoja, Toms; Sanchez, Luis Mara; Martnez Pecino, Flora; Tristan, Mario

Fonte:Rev Panam Salud Publica; 19(6): 417-422, jun. 2006. tab.
http://futurehealth.ucsf.edu/pdf_files/Latin.pdfhttp://futurehealth.ucsf.edu/pdf_files/Latin.pdfhttp://futurehealth.ucsf.edu/pdf_files/Latin.pdfhttp://futurehealth.ucsf.edu/pdf_files/Latin.pdfhttp://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=J%20Investig%20Medhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=J%20Investig%20Medhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=J%20Investig%20Medhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=Rev%20Panam%20Salud%20Publicahttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=Rev%20Panam%20Salud%20Publicahttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=Rev%20Panam%20Salud%20Publicahttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=Rev%20Panam%20Salud%20Publicahttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=J%20Investig%20Medhttp://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://pesquisa.bvsalud.org/regional/resources/lis-LISBR1.1-10389http://futurehealth.ucsf.edu/pdf_files/Latin.pdfhttp://futurehealth.ucsf.edu/pdf_files/Latin.pdf


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Artigo [LILACS ID: 433462 ] Idioma: Ingls

Debido a los sesgos que afectan a la publicacin de ensayos clnicos y sus resultados, los

estudios cuyos resultados son positivos son ms fciles de encontrar que los que tienen

resultados sin significacin estadstica y a ello se debe que los primeros estn

sobrerrepresentados. Para contrarrestar este tipo de sesgo se ha propuesto ingresar en un

registro toda investigacin, desde sus comienzos. No obstante, estos registros se encuentran

en distintas fases de evolucin, especialmente en pases en desarrollo, de tal manera que la

Red Cochrane Iberoamericana, parte de la Colaboracin Cochrane, ha establecido el Registro

Latinoamericano de Ensayos Clnicos en Curso (LATINREC, por Latin American Clinical Trial

Registry) con la idea de facilitar el registro de los datos contenidos en el protocolo de todo

ensayo clnico que se est llevando a cabo en un momento dado y poner esa informacin a la

disposicin del pblico. El LATINREC, que viene a respaldar los objetivos de la Organizacin

Mundial de la Salud (OMS), representa un intento por reducir la duplicacin de trabajo y el

financiamiento poco equitativo de la investigacin sobre enfermedades rezagadas al olvido;

por evitar que se efecten investigaciones sobre asuntos de poca cuanta o que se midan

resultados poco tiles; y por fomentar las prcticas ticas y la transparencia. Se han detectado

algunos obstculos mayores que hasta ahora han impedido crear un registro nico y comn de

ensayos clnicos. Con el fin de franquearlos, LATINREC ser un registro gratuito que permitir

hacer bsquedas y que se ceir a la Plataforma Internacional de Registro de Ensayos Clnicos

(ICTRP) de la OMS. Adems, LATINREC permitir que los investigadores ingresen en el registro

cualquier modificacin del protocolo, as como los resultados preliminares. LATINREC ofrecer

grandes ventajas para los consumidores, el gobierno, los profesionales de la salud pblica y la

industria farmacutica al incrementar la accesibilidad de la informacin y la participacin en

los ensayos clnicos. La disponibilidad de informacin objetiva acerca de todo ensayo clnicoque se inicie ayudar a garantizar que todos tengan libre acceso a los conocimientos

generados. (AU)

17.Importancia de la medicina basada en la evidencia para la prcticaclnica/ Importance of evidence-based medicine to clinical practice

ok

Autor(es): Bonfill, Xavier; Schapira, Pablo

Fonte:Colomb. md; 41(2): 187-193, abr.-jun. 2010. tab, ilus.

Artigo [LILACS ID: 573020 ] Idioma: Espanhol

Tipo de publicao: Comentrio

Los profesionales sanitarios, investigadores o gestores sanitarios as como los mismos usuarios

del sistema sanitario necesitan, de forma creciente, informacin clnica relevante sobre la que

deben fundamentar sus propias decisiones. Sin embargo, no suele ser fcil o viable, escrutar

toda la evidencia cientfica que existe sobre el tema de inters. Las revisiones de la literatura

cientfica juegan un papel central en la prctica clnica. Debido a las limitaciones de las

revisiones narrativas, se genera la necesidad de disponer de revisiones sistemticas que

permitan integrar eficientemente toda la informacin vlida y proporcionar una base objetiva
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y fiable para tomar decisiones de manera racional. Las revisiones sistemticas que son sntesis

y anlisis de la informacin con un enfoque prctico, se basan en la mejor evidencia cientfica

disponible, formulan preguntas definidas con claridad y utilizan mtodos sistemticos y

explcitos para identificar y seleccionar estudios, evaluar stos de manera crtica, extraer los

datos de inters y analizarlos. Las revisiones sistemticas en general, y los metaanlisis en

particular, han experimentado en la ltima dcada un gran desarrollo, debido en parte, al auge

del movimiento denominado medicina basada en la evidencia (MBE). El mayor impulso en esta

direccin lo ha dado, sin duda, la Colaboracin Cochrane, una organizacin independiente de

mbito internacional y sin nimo de lucro que pretende ayudar a quienes necesitan tomar

decisiones sanitarias bien informadas. Para ello prepara, actualiza y promociona el acceso a las

revisiones sistemticas sobre las intervenciones de la atencin sanitaria. De modo especial,

digno de nfasis y referencia, ha sido el desarrollo de la Colaboracin Cochrane en

Latinoamrica donde en la actualidad cuenta con un apoyo y soporte estables en la mayora de

los pases.(AU)

Health professionals, researchers and health managers, as users of the health system, need

increasingly clinically relevant information on which to base their own decisions. However, it

is not easy or feasible to scrutinize all existing scientific evidence on the subject of interest.

Reviews of the scientific literature play a central role in clinical practice. Given the limitations

of narrative reviews, there is a need for systematic reviews to efficiently integrate all the

information and provide a valid and reliable objective basis for rational decision making.

Systematic reviews that are a synthesis and analysis of information with a practical approach

are based on the best scientific evidence available; these ask clearly defined questions and use

systematic and explicit methods to identify and select studies, assess them in a critical manner,

extract relevant data, and analyze them. Systematic reviews, in general, and meta-analysis, in

particular, have experienced in the last decade a large increase, in part due to the rise of the

movement called evidence-based medicine (EBM). The biggest push in this direction has been

done, without a doubt, by the Cochrane Collaboration, an independent, international and non-

profit organization that aims to help people needing to take well-informed health decisions.

This prepares updates and promotes access to systematic reviews of health care

interventions. Particularly noteworthy has been the extension of the Cochrane Collaboration

in Latin America, were it currently has a stable partnership and support in most countries.(AU)

18.Good clinical practice in east Africa: a review. okAutor(es): Kimanani E

Fonte:East Afr Med J; 78(10): 550-4, 2001 Oct.


Tipo de publicao: Artigo de Revista; Research Support, Non-U.S. Gov't; Reviso

To call for harmonisation of good clinical practice guidelines in East Africa as one of thenecessary precedents to enhancing their quality and quantity in the region.There were two
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main sources of background information for this review. The first was a series of articles

discussing and documenting the harmonisation process in East Asia and in Latin America. The

other was a short survey conducted in Kenya in July 2000. STUDY AREA SELECTION: Most of

the survey participants were drawn from the Kenya Medical Research Institute (KEMRI) in

Nairobi, Kisumu and Kilifi with a few coming from the vicinity of these areas. DATA

PROCESSING AND ANALYSIS: The survey tool was a fourteen page questionnaire seeking

information in various areas. These were: personal information, general clinical research

information, medical practitioners, clinical research experience, human subject participation,

sponsors, clinical trial supplies, investigator sites and general comments. Data entry was

performed in Microsoft Access. Forty four researchers participated in a period of three weeks.

Data summaries and reports were performed in SAS.The advancing capacity for clinical

research in East Africa will be accelerated by harmonising clinical research requirements and

guidelines.

19.La Colaboracin Cochrane en Cuba. La produccin de informessobre ensayos clnicos realizados en Cuba en las bases de datosMedline y en el Web of Science/ The Cochrane Collaboration in

Cuba. The production of Cuban clinical trial reports in Medline

database and Web of Science ok

Autor(es): Caedo Andalia, Rubn; Arajo Ruiz, Juan A; Arencibia Jorge, Ricardo; Gutirrez

Calzado, Carlos

Fonte:ACIMED; 11(6)nov.-dic. 2003. tab

Artigo [LILACS ID: 355780 ] Idioma: Espanhol

Con el objetivo de identificar las publicaciones realizadas por autores cubanos para informar

sobre los resultados de ensayos clnicos realizados en el pas, tanto en revistas nacionales

como extranjeras, as como de ubicar la posicin de Cuba con respecto al resto de los pases

iberoamericanos y de la regin, se explor la base de datos PubMed/Medline, disponible en

Internet. Adicionalmente, se examinaron las bases de datos del Web of Science. Se hallaron

142 referencias a informes de ensayos clnicos publicados por autores cubanos, con la

participacin o sin ella de autores de otros pases, en Medline. De ellas, 116 se encontraron en

publicaciones extranjeras y 26 en nacionales. Cuba se ubic en el sexto lugar entre los 20

pases analizados del rea, segn la publicacin de informes sobre ensayos clnicos, donde el

primer autor labora en una organizacin perteneciente a dicho pas. Iberoamrica, como

regin, gener un nmero de trabajos similar a la que muestra Finlandia; sin embargo, ms de

la mitad de esta produccin se concentr slo en dos pases: Brasil y Mxico. Es imprescindible

una visin, una conciencia, una infraestructura, una organizacin y una voluntad poltica de los

pases de la regin para estimular la actividad clnico-investigativa de los pases en

Iberoamrica(AU)
http://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=ACIMEDhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=ACIMEDhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=ACIMEDhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis%7Cdatabase_name=TITLES%7Clist_type=title%7Ccat_name=ALL%7Cfrom=1%7Ccount=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=ACIMED


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Newsletter VHL 086 21/january/2009

Clinical trials registry advances in Latin America and the Caribbean

Clinical trials may be better used as resources to support

scientific knowledge by making results both positive and

negative - available. Researchers have the ethical

responsibility with the scientific community and volunteer

subjects to disseminate such results.

To spread clinical trial results in the medical literature and

to make results more transparent, some institutions, such

as the World Health Organization (WHO) and the

International Committee of Medical Journal Editors (ICMJE)

have recommended and supported initiatives for

notification and registry of such studies, in order to identify

ongoing investigations and their respective results,

considering that not all results are published in scientific

articles.

In compliance with the recommendations by the WHO and

the ICMJE, the Pan American Health Organization (PAHO),

together with theBIREME/PAHO/WHO(Latin American and Caribbean Center on Health Sciences

Information), has supported the creation of a platform of Clinical Trial Registry for Latin America

and the Caribbean.

The initiative will enable establishing national registries and an integrated search portal in the

records available in the region. The countries that do not have their own system could adopt the

model proposed to arrange their national registry.

The proposal was presented during the8th Brazilian Congress of Collective Health, held in Rio de

Janeiro, in 2006, and was also discussed with representatives of Argentina, Chile, Cuba, Colombia

and Brazil, during the15th Cochrane Colloquium, held in Sao Paulo, in October 2007. Today, the

region already has the following registries, which have not been certified by the WHO yet: the

Latin American Ongoing Clinical Trial Registry (Latin-Rec), based in Colombia and coordinated by

the Latin American Cochrane Collaboration and theCuban Public Registry of Clinical Trials.

According to the Director of BIREME/PAHO/WHO,Abel Packer, the perspective is that Latin

American and Caribbean would operate their national records in a regional network with many

.

.

.
http://newsletter.bireme.br/new/?newsletter=20090121&lang=enhttp://newsletter.bireme.br/new/?newsletter=20090121&lang=enhttp://www.who.int/en/index.htmlhttp://www.who.int/en/index.htmlhttp://www.who.int/en/index.htmlhttp://www.icmje.org/http://www.icmje.org/http://www.icmje.org/http://www.paho.org/http://www.paho.org/http://www.paho.org/http://www.bireme.br/php/index.php?lang=enhttp://www.bireme.br/php/index.php?lang=enhttp://www.bireme.br/php/index.php?lang=enhttp://www.saudecoletiva2006.com.br/ingles/presentation.phphttp://www.saudecoletiva2006.com.br/ingles/presentation.phphttp://www.saudecoletiva2006.com.br/ingles/presentation.phphttp://www.colloquiumbrasil.info/php/index.phphttp://www.colloquiumbrasil.info/php/index.phphttp://www.colloquiumbrasil.info/php/index.phphttp://www.latinrec.org/http://www.latinrec.org/http://www.latinrec.org/http://registroclinico.sld.cu/welcome-to-the-cuban-register-of-clinical-trials/view?set_language=enhttp://registroclinico.sld.cu/welcome-to-the-cuban-register-of-clinical-trials/view?set_language=enhttp://registroclinico.sld.cu/welcome-to-the-cuban-register-of-clinical-trials/view?set_language=enmailto:[email protected]:[email protected]:[email protected]:[email protected]://registroclinico.sld.cu/welcome-to-the-cuban-register-of-clinical-trials/view?set_language=enhttp://www.latinrec.org/http://www.colloquiumbrasil.info/php/index.phphttp://www.saudecoletiva2006.com.br/ingles/presentation.phphttp://www.bireme.br/php/index.php?lang=enhttp://www.paho.org/http://www.icmje.org/http://www.who.int/en/index.htmlhttp://newsletter.bireme.br/new/?newsletter=20090121&lang=en


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benefits, like in the successful experiences of Virtual Health Library (VHL) andSciELO(Scientific

Eletronic Library Online). "It will be an essential contribution to the development of clinical

research and to transparency of clinical records," he says.

Brazil will also launch its national effort, in the second semester of 2009

the Rebrac (BrazilianRegistry of Clinical Trials). So far, the Brazilian investigators have registered the clinical trials in

Latin American platforms or in registries certified by the WHO, in other regions of the world.

The Rebrac involves the Department Science and Technology (Decit) of theSecretariat of

Science, Technology and Strategic Inputs-Ministry of Health; theFundao Oswaldo Cruz, the

National Health Surveillance Agency (Anvisa), and the National Council of Research Ethics

(Conep). These institutions cooperate with the BIREME/PAHO/WHO and the Research Area of

the PAHO to develop the platform.

Other complementary initiatives have been established by the BIREME/PAHO/WHO at the VHL,

such as theVHL Evidence Portaland theCochrane Portal at the VHL. The Evidence Portal

gathers, organizes and provides integrate access to sources of information on health regarding

the best level of evidence, according to the methodology proposed by the Evidence-based

Medicine (EBM). It also offers contents about the EBM methodology. The Cochrane Portal

collection is composed of eight databases of theCochrane Library theCochrane Plus Library

databases, coordinated by theIberian American Cochrane Center, which provides contents in

Spanish; and the abstracts of the Cochrane systematic reviews, translated into Portuguese by the

Brazilian Cochrane Centre.

According toRenato Murasaki, manager of Information Methodologies and Technologies (MTI)

of the BIREME/PAHO/WHO, the plan for Brazil is to have a platform as one of the sources of

information that may be retrieved at the VHL. Since the contents of the virtual library are inter-

operated with the clinical trials registered at the Rebrac, the trials that have related scientific

articles available at the VHL, will be inter-associated and retrieved by the same search system.

Continuation >>>

Written by: BIREME/PAHO/WHO

17.12.2008 18:06:14 hUpdated by: BIREME/PAHO/WHO22.01.2009 11:44:33 h

Clinical trials registry advances in Latin America and the Caribbean (Part

II)

With the ongoing registry of clinical studies, it will be possible

to manage and avoid conflicts of interest, mainly those related

to research financing, statedRegina Castro, coordinator of

Health Scientific Communication of the BIREME/PAHO/WHO.

There is virtually no publication of negative results of clinical

trials financed by the pharmaceutical industry, which goes against the ethical principles of scientific

communication.

"The adoption of free software on the platform of clinical records will allow the contribution of all
http://www.bireme.br/php/index.php?lang=enhttp://www.bireme.br/php/index.php?lang=enhttp://www.bireme.br/php/index.php?lang=enhttp://www.scielo.org/php/index.php?lang=enhttp://www.scielo.org/php/index.php?lang=enhttp://www.scielo.org/php/index.php?lang=enhttp://dtr2001.saude.gov.br/sctie/decit/index.htmhttp://dtr2001.saude.gov.br/sctie/decit/index.htmhttp://dtr2001.saude.gov.br/sctie/decit/index.htmhttp://dtr2001.saude.gov.br/sctie/http://dtr2001.saude.gov.br/sctie/http://dtr2001.saude.gov.br/sctie/http://dtr2001.saude.gov.br/sctie/http://www.saude.gov.br/http://www.saude.gov.br/http://www.saude.gov.br/http://www.fiocruz.br/cgi/cgilua.exe/sys/start.htm?UserActiveTemplate=template%5Fingles&tpl=homehttp://www.fiocruz.br/cgi/cgilua.exe/sys/start.htm?UserActiveTemplate=template%5Fingles&tpl=homehttp://www.fiocruz.br/cgi/cgilua.exe/sys/start.htm?UserActiveTemplate=template%5Fingles&tpl=homehttp://www.anvisa.gov.br/eng/index.htmhttp://www.anvisa.gov.br/eng/index.htmhttp://www.anvisa.gov.br/eng/index.htmhttp://conselho.saude.gov.br/comissao/eticapesq.htmhttp://conselho.saude.gov.br/comissao/eticapesq.htmhttp://conselho.saude.gov.br/comissao/eticapesq.htmhttp://evidencias.bvsalud.org/php/index.php?lang=enhttp://evidencias.bvsalud.org/php/index.php?lang=enhttp://evidencias.bvsalud.org/php/index.php?lang=enhttp://cochrane.bvsalud.org/portal/php/index.php?lang=enhttp://cochrane.bvsalud.org/portal/php/index.php?lang=enhttp://cochrane.bvsalud.org/portal/php/index.php?lang=enhttp://cochrane.bvsalud.org/cochrane/main.php?lang=pt&lib=COChttp://cochrane.bvsalud.org/cochrane/main.php?lang=pt&lib=COChttp://cochrane.bvsalud.org/cochrane/main.php?lang=pt&lib=COChttp://cochrane.bvsalud.org/portal/php/level.php?lang=en&component=19&item=7http://cochrane.bvsalud.org/portal/php/level.php?lang=en&component=19&item=7http://cochrane.bvsalud.org/portal/php/level.php?lang=en&component=19&item=7http://www.cochrane.es/http://www.cochrane.es/http://www.cochrane.es/http://www.centrocochranedobrasil.org.br/http://www.centrocochranedobrasil.org.br/mailto:[email protected]:[email protected]:[email protected]://espacio.bvsalud.org/boletim.php?articleId=12181706200854&newsLang=enhttp://espacio.bvsalud.org/boletim.php?articleId=12181706200854&newsLang=enmailto:[email protected]:[email protected]:[email protected]:[email protected]://espacio.bvsalud.org/boletim.php?articleId=12181706200854&newsLang=enmailto:[email protected]://www.centrocochranedobrasil.org.br/http://www.cochrane.es/http://cochrane.bvsalud.org/portal/php/level.php?lang=en&component=19&item=7http://cochrane.bvsalud.org/cochrane/main.php?lang=pt&lib=COChttp://cochrane.bvsalud.org/portal/php/index.php?lang=enhttp://evidencias.bvsalud.org/php/index.php?lang=enhttp://conselho.saude.gov.br/comissao/eticapesq.htmhttp://www.anvisa.gov.br/eng/index.htmhttp://www.fiocruz.br/cgi/cgilua.exe/sys/start.htm?UserActiveTemplate=template%5Fingles&tpl=homehttp://www.saude.gov.br/http://dtr2001.saude.gov.br/sctie/http://dtr2001.saude.gov.br/sctie/http://dtr2001.saude.gov.br/sctie/decit/index.htmhttp://www.scielo.org/php/index.php?lang=enhttp://www.bireme.br/php/index.php?lang=en


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countries and its continuous improvement. It will also contextualize the project to address the specific

demands of each country adding information besides the mandatory needs," said Packer.

Organizations encourage registry of clinical trials

The practice of clinical trial registry is recommended by institutions associated to the development and

dissemination of scientific research. In 2004, the ICMJE - also known as the Vancouver Group, composed

of editors of the main medical journals and by a representative of theNational Library of Medicineof the

United States encouraged the creation of a public database of clinical trial registries. The primary aims

were to give an ethically responsible answer to the volunteers participating in clinical research, and to

make the results of such studies public.

Moreover, in 2004, the Declaration of Mexico, resulting from the Ministerial Summit on Health Research,

recommended the WHO to facilitate setting up an international network of clinical trial registries and an

integrated portal of investigations. Based on this recommendation and acting as an international health

institution, the Organization emphasized the advice of the ICMJE about such register and set the Clinical

Trials Registry Platform.

As commented by Timothy Evans, Assistant Director of the WHO, in a press release about the new

standards for register of medical research with human beings, in May 2006, "the register of all clinical

trials and making all the main pieces of information available upon registry are crucial to assuretransparence in medical research and ethical responsibilities with patients and study participants.

The ICMJE and the WHO defined a set of twenty compulsory fields for registry of clinical trials, including

date of performance and register, financing agencies, title of the investigation, main researcher, type of

study and of intervention, study objectives, among other dat

pesquisa clínica américa latina

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