Affiliations: Alma Mater Studiorum Università di Bologna, Scuola di Specializzazione in Studi sull'Amministrazione Pubblica (S.P.I.S.A.), Via Belmeloro n. 10, 40126, Bologna, Italy. E-mail: [email protected]
Abstract: The progress of medicine is based on scientific research as essential
elements to guarantee the fundamental right of health protection. Trials
considered as activities conducted on human subjects designed to test the
validity and the effects of a drug or a medical device in order to evaluate
its safety and efficacy. The normative evolution in the field of clinical
trials shows that interventions in sucessive time, and today, built in
preparation and seek to build a consistent ``corpus'' or set of rules to
ensure the exchange of results of experiments and, therefore, satisfy the
health ``need'' on an international scale. In this context are the two major
areas of experimentation: those promoted by profit promoters and those
promoted by non-profit promoters; the first aims to commercialize the drug,
while the second wants the improvement of clinical practice. The two types
are related to an specific legislation, under a general order dictated
internationally for profit, ad-hoc established by individual States on the
basis of said general legislation for non-profits. Clinical trial, then, in
its normative evolution, the detailed analysis of the distinction between
profit and non-profit and its problems and future prospects.
Keywords: Clinical trials, clinical study, profit and non profit, drugs, medical devices, distinctive element, ethics committees, legislation, health protection
