open access

Vol 65, No 2 (2015)
Invited editorial
Published online: 2015-05-06
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Clinical trials and the new European Union legislation

Agnieszka Byszek, Piotr Rutkowski
DOI: 10.5603/NJO.2015.0019
·
Nowotwory. Journal of Oncology 2015;65(2):93-95.

open access

Vol 65, No 2 (2015)
Invited editorial
Published online: 2015-05-06

Abstract

Clinical trials are fundamental for the advancement of knowledge in medical sciences (including oncology) therefore strict legal and ethical conditions should be applied to their planning and conducting. Regulation No 536/2014 of the European Parliament was enforced in June 2014 to increase the number of clinical trials conducted in EU Mem­ber States. This new legislation regulates clinical trials and is mandatory in all EU countries. These new rules not only simplify the application procedure for authorization of a clinical trial and shorten waiting time for the authorization to begin study, but also introduce new definitions, including biomedical trials or clinical trials with a low degree of intervention. Particularly significant changes concern non-commercial research, including academic research projects in medicine and trials initiated by investigators (Investigator Initiated Study) based on universities, scientific societies, scientific research groups or research institutes. According to the provisions of the Regulation, it is necessary to take national legislative measures in order to support such projects. Therefore, oncology societes in our country propose means to enhance non-commercial clinical trials to be conducted in Poland.

Abstract

Clinical trials are fundamental for the advancement of knowledge in medical sciences (including oncology) therefore strict legal and ethical conditions should be applied to their planning and conducting. Regulation No 536/2014 of the European Parliament was enforced in June 2014 to increase the number of clinical trials conducted in EU Mem­ber States. This new legislation regulates clinical trials and is mandatory in all EU countries. These new rules not only simplify the application procedure for authorization of a clinical trial and shorten waiting time for the authorization to begin study, but also introduce new definitions, including biomedical trials or clinical trials with a low degree of intervention. Particularly significant changes concern non-commercial research, including academic research projects in medicine and trials initiated by investigators (Investigator Initiated Study) based on universities, scientific societies, scientific research groups or research institutes. According to the provisions of the Regulation, it is necessary to take national legislative measures in order to support such projects. Therefore, oncology societes in our country propose means to enhance non-commercial clinical trials to be conducted in Poland.

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About this article
Title

Clinical trials and the new European Union legislation

Journal

Nowotwory. Journal of Oncology

Issue

Vol 65, No 2 (2015)

Article type

Invited editorial

Pages

93-95

Published online

2015-05-06

DOI

10.5603/NJO.2015.0019

Bibliographic record

Nowotwory. Journal of Oncology 2015;65(2):93-95.

Authors

Agnieszka Byszek
Piotr Rutkowski

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