Clinical Trial Application in Europe: What Will Change with the New Regulation?
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The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the different steps including the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC?
KeywordsClinical Trial Application Europe Regulatory Harmonisation
The research leading to these results has received funding from the European Union Seventh Framework Programme FP7/2007-2013 under Grant Agreements No. 261060 (GRiP network of excellence) and No. 261483 (DEEP). Support from the TEDDY network (originated from the now ended FP6 Network of Excellence LSHB-CT-2005-005216) is also gratefully acknowledged.
- Altavilla, A., Giaquinto, C., Giocanti, D., et al. (2009). Activity of ethics committees in Europe on issues related to clinical trials in paediatrics: Results of a survey. Pharmaceuticals Policy and Law, 11(1,2), 79–87.Google Scholar
- Bilbault, P., Belorgey, C., Zannad, F., Golinelli, D., Pletan, Y., & participants of Round Table n°4 of Giens XXV. (2010). Clinical trials legislation—Preparing for the revision of the European Directive Scheduled for 2011. Therapie, 65(4), 301–308.Google Scholar
- CIOMS-WHO. (2002). Council for International Organizations of Medical Sciences in collaboration with the World Health Organization. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International Organizations of Medical Sciences in collaboration with the World Health Organization. International CIOMS-WHO.Google Scholar
- Committee of Ministers. (1995). Recommendation Rec (2006) 4 of the Committee of Ministers to member states on research on biological materials of human origin. Adopted by the Committee of Ministers on 15 March 2006 at the 958th meeting of the Ministers’ Deputies.Google Scholar
- Council of Europe. (2005). Additional protocol to the convention on human rights and biomedicine, concerning biomedical research. CETS n°195. Strasbourg, 2005/01/25.Google Scholar
- EC. (2003). Detailed guidance on the European clinical trials database (EUDRACT Database) April 2003 as amended. COM (03) ENTR/CT 5.Google Scholar
- EC. (2006). Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use. COM(06) ENTR/CT 2).Google Scholar
- EC. (2008). Ethical considerations for clinical trials on medicinal products conducted with the paediatric population—Recommendations of the Ad Hoc Group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use. COM(08).Google Scholar
- EC. (2009). Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) N° 1901/2006. COM (2009/C 28/01).Google Scholar
- EC. (2010). Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1). COM (2010/C 82/01).Google Scholar
- EFGCP. (2012). Report on “The Procedure for the Ethical Review of Protocols for Clinical Research Projects in the European Union”. European Forum for Good Clinical Practice. Update 2012. http://www.efgcp.be/EFGCPReports.asp. Access August 2014.
- EGE. (2012). Statement on the proposal for a regulation of the European Parliament and council on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC European Group on Ethics in Sciences and New Technologies (COM 2012) 369.Google Scholar
- EMA. (2001). ICH Topic E 11. Clinical Investigation of medicinal products in the paediatric population note for guidance on clinical investigation of medicinal products in the paediatric population European Medicines Agency (CPMP/ICH/2711/99).Google Scholar
- EMA. (2002). ICH Topic E 6 (R1): Guideline for good clinical practice. European Medicines Agency CPMP/ICH/135/95.Google Scholar
- EMA. (2012). Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorisation applications to the EU Regulatory Authorities. European Medicines Agency EMA/121340/2011.Google Scholar
- EMA. (2013). Clinical trials submitted in marketing-authorisation applications to the European Medicines Agency. European Medicines Agency EMA/INS/GCP/676319/2012.Google Scholar
- EU ENVI. (2013). Report 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. Parliament Committee on the Environment, Public Health and Food Safety.Google Scholar
- European Parliament and Council of European Union. (2001). Directive 2001/20/EC of 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 Journal L121, 01/05/2001.Google Scholar
- European Parliament and of the Council of the European Union. (1995). Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Official Journal of the European Communities L281/31.Google Scholar
- European Parliament and of the Council of the European Union. (2005). Directive 2005/28/EC of the European Parliament and of the Council of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. Official Journal of the European Union L91.Google Scholar
- European Parliament and of the Council of the European Union. (2006a). Decision 1982/2006/EC of the European Parliament and of the Council of the European Union of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007–2013). Official Journal of the European Union L412/2.Google Scholar
- European Parliament and of the Council of the European Union. (2006b). Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union L378/1.Google Scholar
- European Parliament and of the Council of the European Union. (2014). Regulation (Eu) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official Journal of the European Union L158.Google Scholar
- Kubiak, C., de Andres-Trelles, F., Kuchinke, W., et al. (2009). Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN). Trials, 10, 95.Google Scholar
- UNESCO. (2003). United Nations Educational, Scientific and Cultural Organization International. Declaration on Human Genetic Data, Volume I Records of the 32nd session of the General Conference (Paris, 29 September to 17 October 2003). United Nations Educational, Scientific and Cultural Organization International.Google Scholar
- WMA. (2013). Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects (2013), as amended by 64th World Medical Association WMA General Assembly (Fortaleza, Brazil, October 2013).Google Scholar