Abstract

DURAN QUINTANA, José Antonio. Research in Therapeutics: Clinical trials with drugs. Educ. méd. [online]. 2004, vol.7, suppl.1, pp.51-55. ISSN 1575-1813.

Biomedical research via clinical trials offers certain features: defined aim, immediate applicability, and implementation on human beings. It is subject to the legal system - in Spain, specifically to the Real Decreto 223/2.004. The clinical trial can be defined as the scientific testing of a drug, accepted by the patient and safeguarded by law. In all cases, the basic ethical postulates of independence, equity, virtue, and non-harmfulness must always be respected. The participants in a clinical trial are the promoter, the supervisor, the researcher, and the subjects under trial - all convened by the health authorities. The approval of a clinical trial requires the existence of a specific protocol. The main problem in carrying out clinical trials is to achieve the co-ordination of all the people and institutions taking part.

Keywords : clinical trials; bioethics; drug research.

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