Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Single CTA - an Option for Drug Development in Europe ***

Stefanie Muth (Abschlußjahr: 2010)

Language: English

The entry into force of the Clinical Trials Directive 2001/20/EC was an important step towards a better protection of trial subjects and a higher level of harmonisation of the requirements for clinical trials in Europe. However, the Directive did not reach all its goals and led to an increased administrative burden and higher costs for the conduct of clinical trials. The divergent implementation of the Directive into national legislation in the different Member States counteracts on the idea of harmonisation of European clinical research. This is especially true for the process of submission, review and authorisation of clinical trial applications for multinational clinical trials because almost identical procedures have to be carried out by sponsors, Ethics Committees and National Competent Authorities in every participating country. To overcome the shortcomings of the Directive and to streamline the CTA process several initiatives were launched by different stakeholders during the last years, e.g. the public consultation on the functioning of the Directive by the EU Commission, the Clinical Trials Facilitation Group by the Heads of Medicines Agencies, the ICREL project and the "Road Map Initiative for Clinical Research in Europe". In this master thesis, the views of all relevant stakeholders in clinical research towards the current and the possible future CTA process are elaborated.

As a first step towards a better cooperation between the MS the CTFG introduced the Voluntary Harmonisation Procedure which combines the disseminated review of a CTA with a joint assessment of the MS. In addition, the updated Guideline 2010/C82/01 could lead to some improvements in terms of harmonisation of clinical research. However, many stakeholders including commercial and non-commercial sponsors, CROs, patient organisations and the EMA support the introduction of one single CTA dossier which is identical for all countries participating in a clinical trial and which is submitted electronically to one central body. As a next step, similar to the process of application for a marketing authorisation, the review of the CTA dossier could be conducted similarly to a mutual recognition procedure, a decentralised procedure or a centralised procedure. The central review of a single CTA application could be implemented as an additional option complementing the existing national review process. It would lead to an authorisation of a clinical trial valid throughout the Community and would avoid divergent national assessments and reduce the administrative burden. The submission of a single CTA dossier to a central body followed by a central procedure seems to be the most appropriate approach for a revision of the CTA process. It is obvious that a change of the regulatory framework will be necessary to implement any of these options. Many stakeholders support the adoption of the legislative changes into a regulation which is directly binding for all MS without any transposition into national legislation. Independent of the introduction of a single CTA process the European legislation should be updated in order to harmonise in a binding manner the requirements for the national CTA submission and review. This could be achieved through the transposition of the Directive into a regulation as well.

The shortcomings of the Directive 2001/20/EC and the possible options for a harmonisation and simplification of the CTA process have been addressed by all stakeholders in clinical research. In this master thesis, the different views and proposals with special regard to the central submission and review of a single CTA dossier as an option for drug development in Europe are discussed in detail. It is the responsibility of the EU Commission and of all other stakeholders acting in clinical research to further drive this ongoing process in order to reduce the administrative burden for clinical trials and to maintain the competitiveness of clinical research in Europe in favour of the well-being of the patients.

Pages: 61, Annexes: pages: 8