Ethical and regulatory aspects of clinical trials in paediatric population in the Republic of Macedonia

Ivanovska, Verica and Angelovska, Bistra and Atanasova, Marija and Ivanova, Verica (2014) Ethical and regulatory aspects of clinical trials in paediatric population in the Republic of Macedonia. In: VI Serbian Congres of Pharmacy with international participations, 15-19 Oct 2012, Belgrade, Serbia.

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Abstract

Clinical trials in children should be carried out to provide adequate protection whilst recognising the right to benefit from research. Their vulnerability emphasizes the responsibility to ensure parental permission and assent of able children, assurance of direct benefit for the child with the particular condition, minimization of risk, and scientific necessity of the research. Although there may be ethical concerns about conducting paediatric trials, this has to be balanced by the ethical concerns about giving medicines to a population in which they have not been tested. Specific clinical trials in paediatric populations are required due to age-related differences in the drug handling or drug effects which may lead to different formulation or dose requirements to achieve efficacy or to avoid adverse effects.

Item Type: Conference or Workshop Item (Poster)
Subjects: Medical and Health Sciences > Other medical sciences
Divisions: Faculty of Medical Science
Depositing User: Bistra Angelovska
Date Deposited: 06 Nov 2014 15:05
Last Modified: 04 Aug 2015 11:10
URI: http://eprints.ugd.edu.mk/id/eprint/11194

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