Clinical trials profile: Professionals and sites

Paschoale, Helena S.; Barbosa, Fernanda R.; Nita, Marcelo Eidi; Carrilho, F.J.; Ono‐Nita, Suzane Kioko

doi:10.1016/j.cct.2010.06.002

Cited by 8 publications

(7 citation statements)

References 7 publications

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“…At the end of the 20 th century, there was a growing understanding that the development and distribution of new pharmaceuticals and devices was a rapidly growing industry, generating its own financial, ethical and political growing pains 86 . Globalization of the drug and device development industry has increased dramatically since then, with the U.S., Canada, the UK and Europe still holding the lead in terms of absolute volume of trials and participants, but with the greatest growth being seen in the developing countries of Asia 87 , and more recently, South America 88 . In addition to the opportunity presented by large numbers of potentially treatment-naïve participants that could be accessed in international sites, the opportunity to significantly increase accrual and conduct large-scale multisite studies of interventions is attractive to investigators 89 .…”

Section: The Global Practice Environment For Clinical Research Nursesmentioning

confidence: 99%

Clinical research nursing: A critical resource in the national research enterprise

2012

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Translational clinical research has emerged as an important priority for the national research enterprise, with a clearly stated mandate to deliver prevention strategies, treatments and cures based on scientific innovations faster to the public. Within this national effort, a lack of consensus persists concerning the need for clinical nurses with expertise and specialized training in study implementation and the delivery of care to research participants. This paper reviews efforts to define and document the role of practicing nurses in implementing studies and coordinating clinical research in a variety of clinical settings and differentiates this clinical role from the role of nurses as scientists and principal investigators. We propose an agenda for building evidence that having nurses provide and coordinate study treatments and procedures can potentially improve research efficiency, participant safety, and the quality of research data. We also provide recommendations for the development of the emerging specialty of clinical research nursing.

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Section: The Global Practice Environment For Clinical Research Nursesmentioning

confidence: 99%

Clinical research nursing: A critical resource in the national research enterprise

2012

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“…In Europe and Americas, clinical monitoring had a history of up to thirty years, and the activities were well supported by laws and regulation [5,6]. The investigators and institutions operated under distinct structure and procedures relevant to clinical research, and could basically self-manage for subject enrolment, subject visit, data documentation and report [7,8]. The investigators or sub-investigators could focus on patient assessment and treatment, recording source document, while the Clinical Research Coordinators (CRCs) took up the other administrative activities such as investigator file management, IRB/EC submission and Case Report Form (CRF) entry [9,10].…”

Section: Introductionmentioning

confidence: 99%

Cross-sectional Study on Occupational Stress of Clinical Research Associates in China

Ruan¹

2014

J Clin Trials

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“…Dentro de estas normas reguladoras podemos destacar y citar: -En Cuba se creó en 1991 el Centro Nacional Coordinador de Ensayos Clínicos (CENCEC) (27) ; fue también el primer país de habla hispana acreditado por la Plataforma Internacional de Ensayos Clínicos de la Organización Mundial de la Salud (ICTRP) (28) como un proveedor de datos del mismo.…”

Section: Regulación De Los Ensayos Clínicos En Latinoaméricaunclassified

“…Con la finalidad de desarrollar protocolos de investigación clínica, con enfoque en las prioridades regionales (28) , en el 2005 se creó la Red Nacional de Centros de Investigación Clínica.…”

Section: Regulación De Los Ensayos Clínicos En Latinoaméricaunclassified

Rol del estado en los ensayos clínicos

Mazzetti¹,

Silva-Paredes²,

Cornejo‐Olivas³

2012

Rev Peru Med Exp Salud Publica

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Simposio RESUMENLa regulación de los ensayos clínicos por el Estado es un proceso en constante cambio y adecuación, cuyo reto actual consiste en salvaguardar la seguridad de los participantes y equilibrar la carga administrativa. El desarrollo y la regulación de los ensayos clínicos en los distintos países varían según la realidad, el contexto, su ejecución nacional o multinacional, condicionando que la regulación puramente nacional resulte insuficiente y se precise conocer parte de la regulación internacional. El objetivo de esta publicación es mostrar una visión global del rol de Estado en la regulación de los ensayos clínicos en distintas realidades. Para ello, se ha realizado una revisión de la regulación en la Unión Europea, Estados Unidos de Norteamérica y algunos países de Latinoamérica, para llegar finalmente al Perú. La tendencia actual en la regulación de los ensayos clínicos, se caracteriza por el incremento en los estándares de calidad, el garantizar la seguridad de los participantes, promover la transparencia, la disminución de los procesos burocráticos y el fortalecimiento de los comités de ética, en el marco de procesos democráticos abiertos, que convoquen e integren a todos los interesados en procesos dinámicos basados en el conocimiento actual y los cambios que se suceden. El reto actual es promover el desarrollo de ensayos clíni-cos desde el Estado (universidades, centros de investigación, institutos especializados, hospitales, etc.) para los aspectos que el país necesita, incluidos medicamentos huérfanos, enfermedades prevalentes y abandonadas, y el uso terapéutico de los principios activos originarios. Palabras clave: Ensayos clínicos aleatorios; Políticas públicas de salud; Regulación y fiscalización en salud (fuente: DeCS BIREME). ABSTRACTThe regulation of clinical trials by the Government is a process of continuous change and adaptation, current challenge is to ensure the safety of participants and get balance of administrative procedures. Development and regulation of clinical trials in different countries vary according to the situation, context national or international execution, determining the insufficiency of national regulation requiring review of international regulation. The aim of this publication is to present a comprehensive overview of the role of Government in the regulation of clinical trials in different realities. It includes a review of the regulation in The European Union, The United States and some Latin American countries and finally the regulation in Peru. Contemporary trends in the regulation of clinical trials, are characterized by increasing standards of quality, ensuring the safety of the participants, promote transparency, lower bureaucratic processes and strengthening ethics IRB committees in the framework of open democratic processes, involving all stakeholders in dynamic processes based on current knowledge and changing tendencies. The challenge is to promote the development of clinical trials from the government institutions (universities, research centers, ...

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Clinical trials profile: Professionals and sites

Cited by 8 publications

References 7 publications

Clinical research nursing: A critical resource in the national research enterprise

Clinical research nursing: A critical resource in the national research enterprise

Cross-sectional Study on Occupational Stress of Clinical Research Associates in China

Rol del estado en los ensayos clínicos

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