1. Review of regulation of biological and biotechnological products in Latin American and Caribbean countries.

ok
Autor(es): Pombo ML; Di Fabio JL; Cortes Mde L Fonte: Biologicals; 37(5): 271-6, 2009 Oct. Artigo [MEDLINE PMID: 19664935 ] Idioma: Ingls Tipo de publicao: Artigo de Revista; Reviso The regulation of the biological and biotechnological products constitutes a significant challenge, since they are part of a sector of the pharmaceutical industry that is currently experiencing rapid growth. Unlike conventional medicines, the manufacture of these products involves the use of living organisms and processes that impede manufacturing consistency. Even though there are numerous international reference documents related to biotechnological product regulation, there is no consensus by official entities that are considered reference institutions, with regard to the most important definitions used and the mechanisms for product regulation. The Pan-American Health Organization (PAHO), through the Technology, Health Care and Research Area, has developed a series of activities that are described in this document. The objective of this publication is to present the current picture of biotechnological and biological product regulation in the Latin American and Caribbean Region, in order to offer guidance that will facilitate the regulation of these products in a harmonized manner among the countries of the Member States, as well as responding to the request from some regulatory agencies to address the growing demand for licensing applications of these products. Assunto(s): Produtos Biolgicos/uso teraputico Biotecnologia/legislao & jurisprudncia Pesquisa Biomdica/legislao & jurisprudncia Regio do Caribe Coleta de Dados Poltica de Sade/legislao & jurisprudncia Pesquisa sobre Servios de Sade/legislao & jurisprudncia Humanos Amrica Latina Organizao PanAmericana da Sade/organizao & administrao

2. Research contribution of different world regions in the top 50 biomedical journals (1995-2002). ok
Autor(es): Soteriades ES; Rosmarakis ES; Paraschakis K; Falagas ME Fonte: FASEB J; 20(1): 29-34, 2006 Jan. Artigo [MEDLINE PMID: 16394264 ] Idioma: Ingls Tipo de publicao: Estudo Comparativo; Artigo de Revista We evaluated all articles published by different world regions in the top 50 biomedical journals in the database of the Journal Citation Reports-Institute for Scientific Information for the period between 1995 and 2002. The world was divided into 9 regions [United States of America (the U.S.), Western Europe, Japan, Canada, Asia, Oceania, Latin America, and the Caribbean, Eastern Europe, and Africa] based on a combination of geographic, economic and scientific criteria. The number of articles published by each region, the mean impact factor, and the product of the above two parameters were our main indicators. The above numbers were also adjusted for population 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 onetenth of articles came from the rest of the world. Canada, however, ranked second when

number of articles was adjusted for population size. The U.S. is by far the highestranking country/region in publications in the top 50 biomedical journals even after adjusting for population size, gross national product, and other factors. Canada and Western Europe share the second place while the rest of the world is far behind. Assunto(s): Pesquisa Biomdica/estatstica & dados numricos Publicaes Peridicas como Assunto/estatstica & dados numricos frica sia Pesquisa Biomdica/economia Canad Regio do Caribe Amrica Central Europa (Continente) Internacionalidade Amrica Latina Oceania Densidade Demogrfica Fatores de Tempo Estados Unidos

3. Health research in Latin America. ok

Autor(es): Becerra F; Cuervo LG Fonte: Lancet; 375(9709): 120, 2010 Jan 9. Artigo [MEDLINE PMID: 20109887 ] Idioma: Ingls Tipo de publicao: Comentrio; Carta Assunto(s): Pesquisa Biomdica Poltica de Sade Congressos como Assunto Humanos Amrica Latina Apoio Pesquisa como Assunto

4. Cross-sector learning among researchers and policy-makers: the search for new strategies to enable use of research results. ok
Autor(es): Pittman P; Almeida C Fonte: Cad Saude Publica; 22 Suppl: S97-108, 2006. Artigo [MEDLINE PMID: 17086343 ] Idioma: Ingls Tipo de publicao: Artigo de Revista This paper assesses the preliminary results of a research funding strategy that alters the structure and process of research by requiring interaction between researchers and policy-makers. The five research teams focused on different aspects of expanding social protection in health in Latin America and the Caribbean. Preliminary results revealed negotiation 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. As the projects advanced, turnover among government officials on four of the teams impaired the process. However, for the one team that escaped re-composition, the interaction 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 the importance of stimulating systems of learning in which multiple kinds of knowledge interact. This interaction may be a more realistic expectation of such initiatives than the original goal of [quot ]transferring[quot ] research knowledge to policy and practice. Assunto(s): Pessoal Administrativo Pesquisa Biomdica/economia Tomada de Decises Relaes Interprofissionais Formulao de Polticas Pesquisadores Regio do Caribe Financiamento Governamental Conhecimentos, Atitudes e Prtica em Sade Pesquisa sobre Servios de Sade Humanos Cooperao Internacional Amrica Latina Organizao Pan-Americana da Sade Projetos de Pesquisa Apoio Pesquisa como Assunto/organizao & administrao

5. Latin America faces hurdles in health research. ok

Autor(es): Moloney A Fonte: Lancet; 374(9695): 1053-4, 2009 Sep 26. Artigo [MEDLINE PMID: 19790287 ] Idioma: Ingls Tipo de publicao: Notcias Assunto(s): Pesquisa Biomdica/economia Apoio Pesquisa como Assunto Amrica Latina

6. Research priorities for neglected infectious diseases in Latin America 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 OF Fonte: PLoS Negl Trop Dis; 4(10): e780, 2010. Artigo [MEDLINE PMID: 21049009 ] Idioma: Ingls Tipo de publicao: Artigo de Revista; Research Support, Non-U.S. Gov't; Reviso Assunto(s): Pesquisa Biomdica/tendncias Doenas Transmissveis/epidemiologia Doenas Negligenciadas/epidemiologia Pesquisa Regio do Caribe/epidemiologia Doenas Transmissveis/diagnstico Doenas Transmissveis/quimioterapia Humanos Amrica Latina/epidemiologia Doenas Negligenciadas/diagnstico Doenas Negligenciadas/quimioterapia Doenas Negligenciadas/preveno & controle

7. Clinical Research in Emerging Countries--Third Annual Marcus Evans Conference.

Autor(es): Singh S Fonte: IDrugs; 11(10): 724-7, 2008 Oct. Artigo [MEDLINE PMID: 18828071 ] Idioma: Ingls Tipo de publicao: Congressos Assunto(s): Pesquisa Biomdica Ensaios Clnicos como Assunto Pases em Desenvolvimento Servios Terceirizados Projetos de Pesquisa frica Pesquisa Biomdica/economia Pesquisa Biomdica/legislao & jurisprudncia Pesquisa Biomdica/organizao & administrao China Ensaios Clnicos como Assunto/economia Ensaios Clnicos como Assunto/legislao & jurisprudncia Indstria Farmacutica Regulamentao Governamental Fidelidade a Diretrizes Guias como Assunto Humanos ndia Cooperao Internacional Japo Amrica Latina Seleo de Pacientes Projetos de Pesquisa/legislao & jurisprudncia Apoio Pesquisa como Assunto Federao Russa Tamanho da Amostra

8. Mexican billionaire invests millions in Latin American health. ok

Fonte: Bull World Health Organ; 85(8): 574-5, 2007 Aug.

Artigo [MEDLINE PMID: 17768511 ] Idioma: Ingls Tipo de publicao: Notcias Assunto(s): Academias e Institutos/economia Fundaes/economia Prioridades em Sade/economia Acesso aos Servios de Sade/organizao & administrao Academias e Institutos/organizao & administrao Pesquisa Biomdica/organizao & administrao Pases em Desenvolvimento Fundaes/organizao & administrao Prioridades em Sade/organizao & administrao Humanos Amrica Latina Mxico

9. Publicaciones biomdicas: realidad de Chile y Latinoamrica/ Biomedical publications: Chilean and Latin American reality ok
Glvez M, Marcelo Rev. chil. radiol; 12(3): 113-117, 2006. tab, graf Artigo [LILACS ID: lil-453337 ] Idioma: Espanhol

10. Health research and developing nations. No

Bloom BR Hastings Cent Rep; 6(6): 9-12, 1976 Dec. Artigo [MEDLINE PMID: 993018 ] Idioma: Ingls

11. Trends in the publication of scientific research in travel medicine from Latin America. ok
Rodriguez-Morales AJ; Palacios H Travel 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? A citation 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. ok

Orellana C Lancet Oncol; 4(9): 523, 2003 Sep. Artigo [MEDLINE PMID: 12965281 ] Idioma: Ingls

14. Science at a Crossroads: Advancing Biomedical Research in Latin America

Autor(es): Pew Latin American Fellows Program; Jennifer Y. Ruzek; Rusten,Nona Kocher; Montano de Jimnez, H. Cheryl Silvia; O Neil, Edward H. [LIS ID: LISBR1.1-10389 ] Idioma: Ingls The report begins with a summary history of biomedical research in the region. A detailed account follows of current government, foundation and private industry funding, which provides context for understanding the regional challenges that lie ahead. Next, the report summarizes the Pew alumni survey to reveal scientists thoughts about programmatic progress and future challenges. The report concludes with a set of recommendations that address long- and shortterm challenges. (Au) Assunto(s): Polititica Tendencias Pesquisa Biomdica Indicadores Indicadores America Latina
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. Artigo [MEDLINE PMID: 17850733 ] Idioma: Ingls 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.

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 clnico que 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 prctica clnica/ 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

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 nonprofit 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. ok

Autor(es): Kimanani E Fonte: East Afr Med J; 78(10): 550-4, 2001 Oct. Artigo [MEDLINE PMID: 11921601 ] Idioma: Ingls 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 the necessary precedents to enhancing their quality and quantity in the region.There were two

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 informes sobre ensayos clnicos realizados en Cuba en las bases de datos Medline 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)

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 the BIREME/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 the 8th 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 the 15th 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 the Cuban 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

benefits, like in the successful experiences of Virtual Health Library (VHL) and SciELO (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 (Brazilian Registry 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 the Secretariat of Science, Technology and Strategic Inputs - Ministry of Health; the Fundao 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 the VHL Evidence Portal and the Cochrane 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 the Cochrane Library the Cochrane Plus Library databases, coordinated by the Iberian 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 to Renato 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 interoperated 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 h Updated by: BIREME/PAHO/WHO 22.01.2009 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, stated Regina 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

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 the National Library of Medicine of 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 assure transparence 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 data fields that make up the minimum items required for all registries of clinical trials, so that it is possible to interchange data and inform about ongoing and completed studies. Although the ICMJE does not recommend any specific Registry of Clinical Trials, it suggests researchers to choose those that contain all these fields. Scientific journals require register of clinical trials In 2005, the ICMJE recommended editors to accept for publication only articles on clinical trials that had been previously registered in a database of Registry of Clinical Trials. The registers must be made before starting the trial and selection of subjects for the study. According to the ICMJE, this editorial policy must be adopted for studies conducted as from July 2005, and for ongoing studies registered before September 2005. The recommendation was immediately supported by editors of medical journals from developed countries, and first by those that are members of the ICMJE. To comply with the WHO proposal for Latin American and Caribbean countries, the BIREME/PAHO/WHO also launched a recommendation to the editors of journals indexed at the database LILACS (Latin American and Caribbean Literature on Health Sciences), in May 2007. In this suggestion, the BIREME/PAHO/WHO sets that all editors of Latin American medical journals must require the registry number of articles with clinical trial results, as well as the criteria for the paper to be accepted. In accordance with the model proposed by the ICMJE, the BIREME/PAHO/WHO suggests a text for the editors, including orientations about the need to register clinical researches in the Instructions for Authors of their journals. The updating of the instructions in the medical journals indexed at the SciELO (Scientific Electronic Library Online) has been monitored by the BIREME/PAHO/WHO to follow up the adoption of the recommendation. Likewise, the BIREME/PAHO/WHO has supervised the indication of the register number in articles on clinical trials by authors and editors. The first articles on clinical trials previously registered started to be published at the SciELO and LILACS in the end of 2008. The WHO coordinates international initiative of Registry of Clinical Trials The International Clinical Trials Registry Platform (ICTRP), coordinated by the WHO, offers a research portal open to the general public, which enables integrated search in all databases certified by the WHO and included in the platform. In the advanced search option, the users may search by: any word of the title, clinical condition, type of intervention, state of recruiting, as well as by sponsors of studies. It is possible to select the countries where the studies are conducted, to establish time intervals and to define if the search will be performed in a specific registry or in all registries.

The following initiatives have already been certified Australian New Zealand Clinical Trials Registry (ANZCTR) Chinese Clinical Trial Register (ChiCTR) ClinicalTrials.gov (United States) Clinical Trials Registry India (CTRI) ISRCTN.org (England) The Netherlands National Trial Register (NTR) Sri Lanka Clinical Trials Registry (SLCTR) German Clinical Trials Register (DRKS) Iranian Registry of Clinical Trials (IRCT) Japan Primary Registries Network

Related link Recommendation to editors of journals indexed at the LILACS and SciELO on register of clinical trials

Written by: BIREME/PAHO/WHO 17.12.2008 18:06:54 h Updated by: BIREME/PAHO/WHO 22.01.2009 11:45:33 h