Trials, Regulation and tribulations

European Journal of Clinical Pharmacology
Carlo Petrini, Silvio Garattini

Abstract

Regulation EU 536/2014 EU introduces a separation between two parts (technical-scientific aspects and locally relevant ethical aspects) in the assessment of applications for approval of trials and provides for each 'Member State concerned' to arrive at 'one single decision' regarding the application for authorisation to conduct a trial. The Regulation should be implemented in such a way as to avoid a separation between scientific assessment and ethical assessment; guarantee the absence of conflicts of interest in the institutions responsible for decision-making; promote efficiency on the part of ethics committees. In particular, (i) it is not appropriate to assess Parts I and II of the application for approval to conduct a trial separately (scientific soundness is the principal requisite for ethical soundness); (ii) conflicts of interest should be avoided, especially as regards links with the national authority responsible for drugs regulation; (iii) decision-making in each state should be the responsibility of a single coordinating ethics committee divided into sections specialising in different therapeutic fields; (iv) local committees affiliated to institutions where trial participants are recruited should be able to interac...Continue Reading

References

May 20, 2000·JAMA : the Journal of the American Medical Association·E J EmanuelC Grady
Apr 23, 2010·Clinical Medicine : Journal of the Royal College of Physicians of London·Victor LarcherUNKNOWN UK Clinical Ethics Network

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Citations

May 10, 2019·Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz·Dirk Lanzerath
Jun 2, 2017·European Journal of Clinical Pharmacology·Eugenijus GefenasVilma Lukaseviciene

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