Aspectos éticos de la investigación clínica en neumología

Uzquiano, Emma Fernández de; Álvarez-Sala, R.

doi:10.1157/13084398

Cited by 6 publications

(3 citation statements)

References 11 publications

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“…It is worth noting, in our country, the lack of knowledge regarding the obligations and responsibilities that acting as sponsor implies, as well as the norms of good clinical practice for the sponsor and investigator [26].…”

Section: Trials By Promoter Typementioning

confidence: 99%

The Spectrum of Clinical Research with Medications in A Spanish University Hospital. Review of 1.000 Clinical Trials Evaluated by the Research Ethics Committee

Uzquiano¹,

Aguado²,

Uriol³

et al. 2009

TOJ

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Objectives:The principal objective of the study was to conduct a descriptive review of 1.000 clinical trials (CT) evaluated by the Research Ethics Committee (REC) of a universitary hospital the Autonomous Region of Madrid, to define the map of current clinical research and its concordance with official priority lines of investigation in Spain.Methods: This is a prospective and analytic observational study of 1.000 CT, (980 with medicines), whose data were collected during a period of six years (May 1999-May 2005 in the Hospital Universitario La Paz of Madrid. It analyzes the intrinsic characteristics of the 1.000 CT evaluated over this period.Results: For this study, 621 CT are being conducted in the medical area, 99 in pharmacology, 90 in surgery, 87 in pediatrics, 42 in primary care centers, 28 in anesthesia and resuscitation, 25 in obstetrics and gynecology, 13 in central services, and 13 in external centers that are non-dependent on the public health system. Of them, 151 CT are uni-center and 849 multi-center, 490 of which are international. In terms of development phase, 103 are phase I, 128 phase II 468 phase III, and 215 phase IV. Sixty-six observational studies were evaluated, as well as 20 epidemiological studies. In 86%, the sponsor is the pharmaceutical industry. In 597 of the CT, the principal objectives of the study have been to evaluate efficacy and safety. The population in 913 of the CT is adult, and pediatric in the remaining 87. Conclusions:The CT with medicines were the most often evaluated, and the most frequent of those being phase III protocols, multi-centric and international, with primary objectives of efficacy and safety in adult patients, and sponsored almost exclusively by the pharmaceutical industry. The medical attending area of the hospital has the greatest prominence of studies and the priority research lines were infectious diseases, especially HIV infection, prevention of cardiovascular risk, rheumatological pathology, and studies of bioavailability. Genetic studies (pharmacogenetics and investigation of genes responsible for pathologies) have in recent years become an important component of CT.

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Section: Trials By Promoter Typementioning

confidence: 99%

The Spectrum of Clinical Research with Medications in A Spanish University Hospital. Review of 1.000 Clinical Trials Evaluated by the Research Ethics Committee

Uzquiano¹,

Aguado²,

Uriol³

et al. 2009

TOJ

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“…118 Our commitment to our community obliges us to move into new areas and face new challenges, such as involving ourselves more in caring for the critically ill respiratory patient and promoting the creation of intermediate respiratory care units where pneumologists can themselves manage severe pneumonia. The objectives were ambitious and, when a project of this scope comes to an end, one is always left with the feeling that more could have been accomplished or something could have been done better.…”

mentioning

confidence: 99%

2004: Año de la Neumonía. Consecuencias e impacto científico en Archivos de Bronconeumología

Naranjo

Marco

2006

Archivos de Bronconeumología

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Pneumonia is a common and potentially serious infectious disease. Morbidity and mortality rates continue to be high in spite of major advances and steady progress in diagnosis and treatment. The economic impact of the disease is also great. It is therefore necessary to enlist the public, primary care and emergency physicians, and public policy administrators to join forces to treat and prevent pneumonia for the common good. The annual incidence of pneumonia in the population over the age of 14 years is 1.6 to 2.6 episodes/1000 inhabitants. The mortality rate is 14.1 per 100,000 inhabitants, and the associated costs are 115 million euros annually. The RESPIRA Foundation and the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) declared 2004 to be pneumonia awareness year with the aim of coordinating efforts to raise awareness, distribute information, and foster debate.

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“…We are aware that we must defend our specialty and broaden the horizons of clinical research, which plays an increasingly important role in pneumology. 118 Our commitment to our community obliges us to move into new areas and face new challenges, such as involving ourselves more in caring for the critically ill respiratory patient and promoting the creation of intermediate respiratory care units where pneumologists can themselves manage severe pneumonia. 119 We must remember that other respiratory infections loom.…”

mentioning

confidence: 99%

Pneumonia Awareness Year, 2004: Scientific Impact Through Publications in Archivos de Bronconeumología

Naranjo

Marco

2006

Archivos de Bronconeumología ((English Edition))

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Aspectos éticos de la investigación clínica en neumología

Cited by 6 publications

References 11 publications

The Spectrum of Clinical Research with Medications in A Spanish University Hospital. Review of 1.000 Clinical Trials Evaluated by the Research Ethics Committee

The Spectrum of Clinical Research with Medications in A Spanish University Hospital. Review of 1.000 Clinical Trials Evaluated by the Research Ethics Committee

2004: Año de la Neumonía. Consecuencias e impacto científico en Archivos de Bronconeumología

Pneumonia Awareness Year, 2004: Scientific Impact Through Publications in Archivos de Bronconeumología

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