RESUMO
Clinical research is the most important tool for the identification of diagnostic and therapeutic strategies that derive in higher efficacy and safety. Despite its significance, successful implementation of clinical research faces numerous difficulties, with one the most relevant being limited availability of resources for the performance of independent clinical trials. Generally, the pharmaceutical industry absorbs the costs associated with most clinical trials; however, this can generate dissociation between subjects of interest and health priorities when economic interest is the main driver of these protocols. In addition to the relevant role played by the pharmaceutical industry, it is important that government agencies favor adequate conditions, both in economic and regulatory aspects, for the implementation of independent clinical research that addresses subjects of medical and therapeutic interest, even if it does not generate corporate economic benefits.
La investigación clínica es la herramienta de mayor importancia para la identificación de estrategias diagnósticas y terapéuticas que deriven en mayor eficacia y seguridad. A pesar de su trascendencia, la implementación exitosa de la investigación clínica presenta numerosas dificultades; entre las más relevantes se encuentra la poca disponibilidad de recursos para realizar ensayos clínicos independientes. Por lo general, la industria farmacéutica absorbe los costos asociados con la mayoría de los ensayos clínicos, sin embargo, esto puede generar una disociación entre los temas de interés y las prioridades en salud, al existir interés económico como principal motivación de estos protocolos. Además del papel relevante de la industria farmacéutica, es importante que las instancias gubernamentales favorezcan las condiciones, tanto económicas como regulatorias, para la implementación de investigación clínica independiente, que aborde temas de interés médico y terapéutico, aunque no genere beneficios económicos empresariales.
Assuntos
Pesquisa Biomédica/organização & administração , Ensaios Clínicos como Assunto/organização & administração , Indústria Farmacêutica/organização & administração , Pesquisa Biomédica/economia , Ensaios Clínicos como Assunto/economia , Indústria Farmacêutica/economia , Apoio Financeiro , HumanosRESUMO
Resumen La investigación clínica es la herramienta de mayor importancia para la identificación de estrategias diagnósticas y terapéuticas que deriven en mayor eficacia y seguridad. A pesar de su trascendencia, la implementación exitosa de la investigación clínica presenta numerosas dificultades; entre las más relevantes se encuentra la poca disponibilidad de recursos para realizar ensayos clínicos independientes. Por lo general, la industria farmacéutica absorbe los costos asociados con la mayoría de los ensayos clínicos, sin embargo, esto puede generar una disociación entre los temas de interés y las prioridades en salud, al existir interés económico como principal motivación de estos protocolos. Además del papel relevante de la industria farmacéutica, es importante que las instancias gubernamentales favorezcan las condiciones, tanto económicas como regulatorias, para la implementación de investigación clínica independiente, que aborde temas de interés médico y terapéutico, aunque no genere beneficios económicos empresariales.
Abstract Clinical research is the most important tool for the identification of diagnostic and therapeutic strategies that derive in higher efficacy and safety. Despite its significance, successful implementation of clinical research faces numerous difficulties, with one the most relevant being limited availability of resources for the performance of independent clinical trials. Generally, the pharmaceutical industry absorbs the costs associated with most clinical trials; however, this can generate dissociation between subjects of interest and health priorities when economic interest is the main driver of these protocols. In addition to the relevant role played by the pharmaceutical industry, it is important that government agencies favor adequate conditions, both in economic and regulatory aspects, for the implementation of independent clinical research that addresses subjects of medical and therapeutic interest, even if it does not generate corporate economic benefits.
Assuntos
Humanos , Ensaios Clínicos como Assunto/organização & administração , Pesquisa Biomédica/organização & administração , Indústria Farmacêutica/organização & administração , Apoio Financeiro , Ensaios Clínicos como Assunto/economia , Pesquisa Biomédica/economia , Indústria Farmacêutica/economiaRESUMO
The European Medicines Agency has opened a window to access clinical trial data. This is an important step forward which deserves attention, support, and advice from all the stakeholders. Regulatory agencies are the most comprehensive repositories of clinical trial data on drugs and can also promote and develop standard practices for data sharing. The release of the EMA draft policy on publication and access to clinical trial data in 2013 has fueled a lively debate among academia, industry, and the public in general that is still ongoing. As clinical researchers and producers and users of clinical trial data, we endorse the European Medicines Agency's opening and offer a few suggestions for complete, safe, and effective data sharing.
