title: [Regulatory aspects and medicolegal considerations regarding clinical drug trials].
abstract: This article aims to explore the regulatory and medicolegal aspects of experimental drug trials. Firstly, the authors provide definitions of drug according to WHO, the European Community and our official Pharmacopoeia, and that of experimental studies. They then explain the distinction between pure or basic research and drug trials and explain the various phases of the latter. Besides providing definitions, and exploring doctrinal, theoretical but also practical aspects of drug trials, the authors also discuss and analyze legislative aspects, with particular reference to the Italian legislative framework, and medicolegal issues, including informed consent, effects on humans, and professional responsibility.
authors.affiliation: Professore Aggregato presso la Cattedra di Medicina Legale, Università degli Studi di Roma Tor Vergata, Italia.
authors.forename: Andrea
authors.initials: A
authors.lastname: Cammarano
authors.affiliation: Medico Chirurgo in Formazione Specialistica presso la Cattedra di Medicina Legale, Università degli Studi di Roma Tor Vergata, Italia.
authors.forename: Enrico
authors.initials: E
authors.lastname: De Dominicis
authors.affiliation: Dottore di Ricerca in Criminalistica presso la Cattedra di Medicina Legale, Università degli Studi di Roma Tor Vergata, Italia.
authors.forename: Gian Luca
authors.initials: GL
authors.lastname: Marella
authors.affiliation: Professore Aggregato presso il Dipartimento di Biomedicina e Prevenzione, Università degli Studi di Roma Tor Vergata, Italia.
authors.forename: Massimo
authors.initials: M
authors.lastname: Maurici
authors.affiliation: Direttore della Cattedra di Medicina Legale, Università degli Studi di Roma Tor Vergata, Italia.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Arcudi
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational; D004992:Ethics, Medical; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007558:Italy; D011634:Public Health / Q000331:legislation & jurisprudence*; D014944:World Health Organization
chemical_list: D015507:Drugs, Investigational