Pharmaceutical Ethics

By Sam Salek; Andrew Edgar | Go to book overview

6
Clinical Trials of
Pharmaceuticals: Ethical
Aspects

OLIVIER CHASSANY1,*, MARTIN DURACINSKY2 AND ISABELLE MAHÉ3

1Délégation à la Recherche Clinique, Assistance Publique—Hôpitaux de Paris, 75010 Paris, France 2Department of Internal Medicine, Saint-Louis University Hospital, 75010, Paris, France 3Department of Internal Medicine, Lariboisière University Hospital, 75010 Paris, France


SUMMARY

Since the Nuremberg Code in 1947, several codes of human rights in medical research have been released. The best known and current reference guideline is the Declaration of Helsinki. Three major principles are emphasized, i.e. respect for patients, beneficence and justice. Respect of the patient to accept or not participate in a trial; the constraints and presumed risks must be acceptable for patients 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 a placebo in order to prove 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 a placebo, whatever the

*Reviewer at the French Drug Agency, member of a Parisian Ethics Committee.

Pharmaceutical Ethics. Edited by S. Salek and A. Edgar. © 2002 John Wiley & Sons, Ltd.

-71-

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