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Identifier

000352271

Title

Ανάπτυξη των φαρμάκων και κλινικές δοκιμές

Author

Θεοδωροπούλου, Φανή

Thesis advisor

Φιλαλήθης, Τάσος
Αστρινάκης, Αντώνιος
Θερμού, Κική

Abstract

Clinical trials constitute an indispensable tool for the development of new drugs and treatments. Through them the safety and efficacy of pharmaceuticals to humans is being secured and the medical knowledge is being enriched. The methodology followed in a clinical trial is explicitly defined and designed so that it can respond to specific scientific queries. Simultaneously, provided that the clinical trial is experimental to humans, it follows regulations of proper design that safeguards that the subjects are treated with an ethical manner. The three principles that compose the regulatory framework are: respect of human dignity and autonomy, beneficence and justice. The most prevalent characteristics of the ethical validity are the voluntary participation and a risk- benefit evaluation that protects the patient’s rights. Securing the informed consent ratifies the morality of a trial and given the fact that it is substantial, it constitutes a security valve for the adherence to the regulatory principles as much for the investigators as well as by (and for) the participants. The administration of placebo, although methodologically indispensable, should be adopted only when it is strongly justified and the principle of not causing harm is secured. Finally, the different cultural traditions and the specific environment where the trial takes place, concerns and divides the scientific and ethical community, as it reveals problems in feasibility and inequalities in the regulatory guidelines. The ΑΖΤ case was the reason for the revision of the Helsinki Code and helped to give more emphasis in the contents of the regulatory framework. A number of local and international committees are involved with the authorization of the clinical trials. Gradually these consulting bodies have formulated regulatory authorities that are embodied in the national legislations. The National Committee of Ethics in Greece, as an independent consulting body, ratifies the ethical appropriateness in the design and conduct of the clinical trials.

Physical description

77 σ. : πιν. ; 30 εκ.

Language

Greek

Subject

Bioethics

Clinical Trials as Topic ethics

Drugs, Investigational

Ethics Committees

Ethics, Medical

Human Experimentation ethics

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