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.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
Notes
The term “marginalization of research ethics committees” was used in the Statement of the European Group on Ethics in Science and New Technologies (EGE) on the Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (COM 2012) 369 final.
For example, through an already existing expert groups established by the European Commission, like Ad hoc group for the development of implementing guidelines for Regulation (EU) no. 536/2014 on clinical trials on medicinal products for human use.
References
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official J Eur Commun L121:34–44
No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official J Eur Commun L158:1–76
Gøtzsche P (2012) Deficiencies in proposed new EU regulation of clinical trials. BMJ. doi:10.1136/bmj.e8522
European Commission (2012) Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. http://ec.europa.eu/health/files/clinicaltrials/2012_07/proposal/2012_07_proposal_en.pdf. Accessed 9 May 2017
NHS European Office (2014) The new EU Clinical Trials Regulation: how NHS research and patients will benefit. http://www.nhsconfed.org/resources/2014/09/the-new-eu-clinical-trials-regulation-how-nhs-research-and-patients-will-benefit. Accessed 9 May 2017
Flear ML (2016) The EU Clinical Trials Regulation: key priorities, purposes and aims and the implications for public health. J Med Ethics. doi:10.1136/medethics-2015-103258
Westra AE, Bos E, Cohen AF (2014) New EU clinical trials regulation. BMJ. doi:10.1136/bmj.g3710
Petrini C, Trials GS (2016) Regulation and tribulations. Eur J ClinPharmacol. doi:10.1007/s00228-016-2009-1
Petrini C (2016) What is the role of ethics committees after Regulation (EU) 536/2014? J Med Ethics. doi:10.1136/medethics-2015-103028
CROMSOURCE (2015). The EU Clinical Trials Regulation—main changes and challenges. http://www.cromsource.com/wp-content/uploads/2015/02/The-EU-Clinical-Trials-Regulation-Main-Changes-and-Challenges.pdf. Accessed 9 May 2017
Westra AE (2016) Ambiguous articles in new EU Regulation may lead to exploitation of vulnerable research subjects. J Med Ethics. doi:10.1136/medethics-2015-102899
The Council of Europe (1997) Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine. https://rm.coe.int/CoERMPublicCommonSearchServices/DisplayDCTMContent?documentId=090000168007cf98 Accessed 9 May 2017
World Medical Association (2013) Declaration of Helsinki: ethical principles for medical research involving human subjects. http://www.wma.net/en/20activities/10ethics/10helsinki/DoH-Oct2013-JAMA.pdf Accessed 9 May 2017
Council for International Organizations of Medical Sciences (2016) International ethical guidelines for biomedical research involving human subjects. http://cioms.ch/ethical-guidelines-2016/WEB-CIOMS-EthicalGuidelines.pdf. Accessed 9 May 2017
Danish Act on Clinical Trials of Medicinal Products (2016) https://laegemiddelstyrelsen.dk/en/news/2016/new-danish-act-on-clinical-trials/~/media/0BDD2C209E3A472EB4DFC00661683433.ashx. Accessed 9 May 2017
The European Forum for Good Clinical Practice (EFGCP) (2016) EFGCP multi-stakeholder workshop & discussion on how to ensure optimal ethical review within the new Clinical Trials Regulation? Where do we currently stand with the implementation in different Member States. Workshop report. http://www.efgcp.eu/Downloads/confDocuments/Report%20EFGCP%20-%20CT%20Regulation%20-%2013%20April%202016.pdf 9. Accessed 9 May 2017
Martin Jimenez M, Calvo Ferrandiz A, Aparicio Urtasun J et al (2017) New clinical trials regulation in Spain: analysis of royal decree 1090/2015. Clin Transl Oncol. doi:10.1007/s12094-016-1550-9
French National Agency for Medicines and Health Products Safety (2016) Clinical Drug Trials submitted within the Pilot Phase to ANSM (French National Agency for Medicines and Health Products Safety) and the CPP (French EthicsCommittee). Practical Information Guide for Applicants. http://ansm.sante.fr/var/ansm_site/storage/original/application/731e30158735dae9e2128f20104572dc.pdf. Accessed 9 May 2017
Druml C, Wolzt M, Pleiner J, Singer EA (2009) Research ethics committees in Europe: trials and tribulations. Intensive Care Med. doi:10.1007/s00134-009-1544-y
Decree of the Ministry of Health of the Republic of Lithuania on the Procedure for Issuing Favourable Opinion to Conduct Clinical Trial on Medicinal Product, Approval for Clinical Trial on Medicinal Product, Conducting and Controlling Clinical Trials, No. 435 (2006). https://www.e-tar.lt/portal/lt/legalAct/TAR.E90706044869/goeEBCNfWi. Accessed 9 May 2017
Acknowledgements
The authors would like to thank the members of the European Network of Research Ethics Committees (EUREC) for sharing their insights on the issues raised in this paper. The authors would also like to thank Phyllis Zych Budka for the editorial corrections.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
The authors declare that they have no conflict of interest.
Rights and permissions
About this article
Cite this article
Gefenas, E., Cekanauskaite, A., Lekstutiene, J. et al. Application challenges of the new EU Clinical Trials Regulation. Eur J Clin Pharmacol 73, 795–798 (2017). https://doi.org/10.1007/s00228-017-2267-6
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00228-017-2267-6