Acceptability and profile of the clinical drug trials underway in
Finnish university hospitals in the 1990s: Applications reviewed by
ethics committees

Keinonen, Tuija; Nieminen, Sakari; Saareks, Virpi; Saano, Veijo; Ylitalo, Pauli

doi:10.1358/mf.2001.23.7.662124

Cited by 10 publications

(13 citation statements)

References 0 publications

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“…This information concurs with that shown by Keinonen et al in their review [16]. In recent years we have seen an increase in studies with marketed drugs and with research objectives concerning health results.…”

Section: Trials By Objectives and Study Populationsupporting

confidence: 91%

“…This data contrasts with a Finnish study from 1990 in which the participation of investigators as sponsors was up to 31%, probably due to the minor difficulty in obtaining the insurance policies financing [16].…”

Section: Trials By Promoter Typecontrasting

confidence: 90%

“…This information coincides with that collected in various international articles [15][16][17]. However, Decullier et al [21] indicated in their study that the majority of research was in the form of national studies (80%) with a predominance of uni-centric studies.…”

Section: Trials By Phase Of Development and Fieldsupporting

confidence: 83%

“…In addition, the principal objective of these studies is to try to analyze and shorten the approval time and required authorizations to initiate trials, as well as to reach greater uniformity among the various REC resolutions that evaluate a multi- centric CT. Only a few of these articles describe the characteristics of the trials [15][16][17][18][19][20][21][22].…”

Section: Discussionmentioning

confidence: 99%

“…It is unavoidable to associate clinical trial with pharmaceutical industry, but the rates are different within countries: 63-64% of the trials are sponsored by the pharmaceutical industry in France, 69% in Finland and 84% in Italy [16,21,22]. We can deduce from these figures that countries with investigational tradition have a lower rate of trials sponsored by pharmaceuticals.…”

Section: Trials By Promoter Typementioning

confidence: 96%

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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 Objectives and Study Populationsupporting

confidence: 91%

Section: Trials By Promoter Typecontrasting

confidence: 90%