Eugenijus Gefenas1,2, Asta Cekanauskaite3,4, Jurate Lekstutiene3,4, Vilma Lukaseviciene3,4. 1. Department of Medical History and Ethics, Medical Faculty of Vilnius University, Vilnius, Lithuania. eugenijus.gefenas@mf.vu.lt. 2. Lithuanian Bioethics Committee, Vilnius, Lithuania. eugenijus.gefenas@mf.vu.lt. 3. Department of Medical History and Ethics, Medical Faculty of Vilnius University, Vilnius, Lithuania. 4. Lithuanian Bioethics Committee, Vilnius, Lithuania.
Abstract
PURPOSE: The purpose of this paper is to discuss the challenges of the upcoming policy change in the field of clinical drug trials due to the shift from the Clinical Trials Directive 2001/20/EC to the new Clinical Trials Regulation 536/2014, adopted in 2014. Although it is expected that the new EU Clinical Trials Regulation will increase Europe's competitiveness in clinical research, the paper argues that some measures to assure protection of research subjects should be taken before the Regulation comes into application in 2018. METHODS: The methods used in this paper are comparative analysis of legal documents and related academic papers. RESULTS: The new Regulation serves as an efficient means to harmonize the clinical drug trial evaluation procedures across the EU. However, its application also raises potential challenges regarding interests and safety of research subjects: first, due to the possibility of skipping the assessment and balancing of benefits and risks from the scope of ethical review and limiting such a review to only Part II issues of the assessment report; second, due to direct applicability of the Regulation's rather vague and too general requirements for investigator's qualifications which does not allow the assessors (ethics committees and (or) competent authorities) to introduce higher qualification requirements for the investigators conducting high-risk clinical drug trials in the national legislation. CONCLUSIONS: There is an urgent need to raise awareness and facilitate debate on potential application challenges of the new Regulation.
PURPOSE: The purpose of this paper is to discuss the challenges of the upcoming policy change in the field of clinical drug trials due to the shift from the Clinical Trials Directive 2001/20/EC to the new Clinical Trials Regulation 536/2014, adopted in 2014. Although it is expected that the new EU Clinical Trials Regulation will increase Europe's competitiveness in clinical research, the paper argues that some measures to assure protection of research subjects should be taken before the Regulation comes into application in 2018. METHODS: The methods used in this paper are comparative analysis of legal documents and related academic papers. RESULTS: The new Regulation serves as an efficient means to harmonize the clinical drug trial evaluation procedures across the EU. However, its application also raises potential challenges regarding interests and safety of research subjects: first, due to the possibility of skipping the assessment and balancing of benefits and risks from the scope of ethical review and limiting such a review to only Part II issues of the assessment report; second, due to direct applicability of the Regulation's rather vague and too general requirements for investigator's qualifications which does not allow the assessors (ethics committees and (or) competent authorities) to introduce higher qualification requirements for the investigators conducting high-risk clinical drug trials in the national legislation. CONCLUSIONS: There is an urgent need to raise awareness and facilitate debate on potential application challenges of the new Regulation.
Entities:
Keywords:
Clinical Trials Regulation; Clinical drug trials; Ethics committees; Research ethics
Authors: M Martin Jimenez; A Calvo Ferrandiz; J Aparicio Urtasun; R Garcia-Campelo; E Gonzalez-Flores; M Lazaro Quintela; M Muñoz Mateu; C A Rodriguez Sanchez; A Santaballa Bertran; J M Sepulveda Sanchez; R Vera Garcia; J A Virizuela Echaburu; M A Segui Palmer Journal: Clin Transl Oncol Date: 2016-10-07 Impact factor: 3.405