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Titolo:
Ethics and clinical trials
Autore:
Chassany, O; Duracinsky, M;
Indirizzi:
Hop Lariboisiere, Dept Internal Med, F-75475 Paris 10, France Hop Lariboisiere Paris France 10 Internal Med, F-75475 Paris 10, France Charles Univ, Sch Med 1, Prague 12108 2, Czech Republic Charles Univ Prague Czech Republic 12108 2 rague 12108 2, Czech Republic
Titolo Testata:
FUNDAMENTAL & CLINICAL PHARMACOLOGY
fascicolo: 4, volume: 13, anno: 1999,
pagine: 437 - 444
SICI:
0767-3981(1999)13:4<437:EACT>2.0.ZU;2-X
Fonte:
ISI
Lingua:
ENG
Soggetto:
GASTROESOPHAGEAL REFLUX DISEASE; RANDOMIZED CONTROLLED TRIALS; HUMAN-IMMUNODEFICIENCY-VIRUS; PLACEBO-CONTROLLED TRIAL; NO LONGER APPROPRIATE; INFORMED CONSENT; DOUBLE-BLIND; METAANALYSIS; DEXFENFLURAMINE; TRANSMISSION;
Keywords:
research ethics; randomised controlled trials; informed consent; ethics committee; placebo; publication ethics;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
72
Recensione:
Indirizzi per estratti:
Indirizzo: Chassany, O Hop Lariboisiere, Dept Internal Med, 2 Rue Ambroise Pare, F-75475 Paris 10, France Hop Lariboisiere 2 Rue Ambroise Pare Paris France 10 , France
Citazione:
O. Chassany e M. Duracinsky, "Ethics and clinical trials", FUN CL PHAR, 13(4), 1999, pp. 437-444

Abstract

The current reference guideline about ethics in clinical trials is the Declaration of Helsinki of human rights in medical research. Three major principles are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable forpatients included in a study, and vulnerable subjects should not participate in studies. The investigator is responsible for obtaining a free and well-informed consent from patients before their inclusion in a study. Where: possible, a new drug should always first be compared to placebo in order toprove its superiority. Else, a small-sized trial comparing a new drug versus a reference treatment can lead to an erroneous conclusion of absence of difference. Moreover, good results or improvement are obtained in at least 30% of cases with placebo, whatever the disease. The use of placebo is unethical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, in some severe diseases even when an active reference treatment is available, and in all moderate and functional diseases. In order to detect flawed studies, most journals now ask for any manuscript submitted and reporting results of a randomised clinical trial to join a checklist in order to verifythe quality of the trial. Finally, it remains the responsibility of the doctor to decide whether or not a protocol is ethical, to participate or not and to include patients or not.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 29/03/20 alle ore 12:17:59