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Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers' perspectives to identify potential barriers

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Date
2011
Author
White, Lauren
Ortiz, Zulma
Cuervo, Luis G
Reveiz, Ludovic
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Abstract
OBJECTIVE: To review and analyze the regulatory framework of clinical trial registration, use of existing tools (publicly accessible national/international registration databases), and users' perspectives to identify possible barriers to registration compliance by sponsors and researchers in Argentina. METHODS: Internationally registered trials recruiting patients in Argentina were found through clincialtrials.gov and the International Clinical Trial Registration Platform (ICTRP) and compared with publically available clinical trials registered through the National Administration of Drugs, Foods, and Medical Devices (ANMAT). A questionnaire addressing hypothesized attitudinal, knowledge-related, idiomatic, technical, economic, and regulatory barriers that could discourage or impede registration of clinical trials was developed, and semi-structured, in-depth interviews were conducted with a purposively selected sample of researchers (investigators, sponsors, and monitors) in Argentina. RESULTS: A response rate of 74.3 percent (n = 29) was achieved, and 27 interviews were ultimately used for analysis. Results suggested that the high proportion of foreign-sponsored or multinational trials (64.8 percent of all protocols approved by ANMAT from 1994-2006) may contribute to a communication gap between locally based investigators and foreign-based administrative officials. A lack of knowledge about available international registration tools and limited awareness of the importance of registration were also identified as limiting factors for local investigators and sponsors. CONCLUSIONS: To increase compliance and promote clinical trial registration in Argentina, national health authorities, sponsors, and local investigators could take the following steps: implement a grassroots educational campaign to improve clinical trial regulation, support local investigator-sponsor-initiated clinical trials, and/or encourage local and regional scientific...(AU)
 
OBJETIVO: Examinar y analizar el marco normativo del registro de ensayos clínicos, el uso de los instrumentos existentes (bases de datos de registro nacionales o internacionales de acceso público), y las perspectivas de los investigadores para determinar posibles obstßculos al cumplimiento del registro por los patrocinadores y los investigadores en la Argentina. MÉTODOS: Se realizó una búsqueda en el sitio web clinicaltrials.gov y en la Plataforma Internacional de Registro de Ensayos Clínicos (ICTRP) de los ensayos clínicos registrados en el ßmbito internacional que reclutan pacientes en la Argentina y los resultados se compararon con los ensayos clínicos incluidos en el registro de acceso público de la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT). Se elaboró un cuestionario que abordaba los hipotéticos obstßculos relacionados con la actitud hacia el registro y el conocimiento de este, así como obstßculos idiomßticos, técnicos y económicos que podrían desalentar o dificultar el registro de los ensayos clínicos, y se llevaron a cabo entrevistas semiestructuradas exhaustivas en una muestra de investigadores seleccionada para este fin (investigadores clínicos, patrocinadores y monitores) en la Argentina. RESULTADOS: Se obtuvo una tasa de respuesta de 74,3 por ciento (n = 29) y finalmente se analizaron 27 entrevistas. Los resultados sugieren que la proporción elevada de ensayos clínicos con patrocinadores extranjeros o los ensayos multinacionales (64,8 por ciento de los protocolos aprobados por la ANMAT entre 1994 y el 2006) pueden contribuir a una deficiencia de comunicación entre los investigadores locales y los funcionarios administrativos ubicados en el extranjero. También se identificaron como factores limitantes para los investigadores y los patrocinadores locales la falta de conocimiento de los recursos internacionales disponibles para el registro y el escaso reconocimiento de la importancia del registro...(AU)
 
Series
Rev Panam Salud Publica;30(5),nov. 2011
Subject
Clinical trials as topic; Registries; Publication Bias; Argentina; Ensayos Clínicos como Asunto; Sistemas de registros; Sesgo de publicación; Argentina; Ensaios Clínicos como Assunto; Pesquisadores; Argentina; Ensaios Clínicos como Assunto; Barreiras de Comunicação; Coleta de Dados; Políticas Editoriais; Fidelidade a Diretrizes; Cooperação Internacional; Internacionalidade; Internet; Entrevistas como Assunto; Conhecimento; Seleção de Pacientes; Publicações Periódicas como Assunto; Viés de Publicação; Editoração; Questionários; Sistema de Registros
URI
http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892011001100007
https://iris.paho.org/handle/10665.2/9443
Citation
White, Lauren,Ortiz, Zulma,Cuervo, Luis G,Reveiz, Ludovic (2011) Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers' perspectives to identify potential barriers. Rev Panam Salud Publica;30(5) 445-452,nov. 2011. Retrieved from http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892011001100007
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  • Pan American Journal of Public Health

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