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

ABSTRACT

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.