Chapter 3 - Profit and non profit clinical trials

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.