Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Commission Proposal for a Clinical Trials Regulation: implications for ethics committees
Dr. Maria Iwe (Abschlußjahr: 2014)
Summary
Language: English
The conduct of clinical trials in the EU is regulated by the “Clinical Trials Directive” 2001/20/EC to ensure the rights and safety of clinical trial participants as well as the reliability and robustness of the generated data in a clinical trial.
According to the impact assessment report of the Commission, “the Clinical Trials Directive is the most heavily criticized piece of legislation of the entire EU acquis for pharmaceuticals”, where the bureaucratic regulatory framework in the EU, hindering the harmonization of administrative requirements has been criticized by all stakeholders and institutions.
When looking at the current different implementation level of the Directive in the Member States, the requirements for sponsors conducting clinical trials, especially for multinational trials, are quite diverse which also leads to different level of protection for trial participants throughout Europe.
The European Commission proposed on 17 July 2012 its “Regulation on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC”. In the EU legislative process the Commission proposal is now subject to discussions by the European Parliament and the Council of the European Union. After its adoption, Directive 2001/20/EC which is in force since 2001, will be replaced approximately 2016.
The proposed Regulation aimes to resolve a number of problems identified with the current legislation and to simplify the rules for conducting clinical trials, thus directly applicable in all MS.
The submission, assessment and decision system for clinical trial applications are the most important key changes proposed by the European Commission. Thus, the options for national clinical trial approval systems in the Member States and the types of collaboration between competent authorities and research ethics committees need to be critically reviewed.
Nevertheless, the Commission proposal is quite ambitious and is demanding a lot from regulatory authorities, ethics committees and sponsors. Different stakeholders had already identified several critical aspects with regard to ethical recognised standards. Some inadequacies would rather have a negative impact on the protection of trial participants because rights, safety and beneficience are not adequately ensured. A clinical trial should be conducted in accordance with the Declaration of Helsinki which specifies that review by an independent ethics committee is essential prior to approval. When looking at the ethical impact of the proposed Regulation it would seriously weaken the protection of trial participants which has been established by the Directive.
The aim of this thesis is to give an overview of the current legislative framework in Europe for Clinical Trials and to outline the EU Commission’s Proposal for a Regulation of the European Parliament and the Council on clinical trials on medicinal products for human use with focus on Ethics Committees.
The thesis will assess the most important proposed changes in comparison with current requirements focusing on the following topics:
- Ethics Committees: One of the key discussion points concerns the questions how Ethics Committees could be involved and how to ensure an appropriate ethical assessment of the clinical trials in the future.
- Safety Reporting during clinical trials.
At the time of writing discussions of the European Parliament and of the Council of the European Union are still taking place. Therefore, this work covers the situation and the content of official documents published by the European Commission and European Parliament up to December 2013.
Pages: 43, Annexes: 4