Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

A Review of the Availability of Information on Ethics Committee Requirements for Clinical Trials in the EU ***

Ralf Rickert (Abschlußjahr: 2009)

Language: English

The Clinical Trials Directive 2001/20/EC that has been implemented in all EU Member States had significant implications on clinical trials with medicinal products within the Community. Amongst others it has affected the ethical review of clinical trials by introducing various provisions for the procedures for obtaining favourable opinions. By this harmonised approach it was intended to simplify the administrative provisions for setting up particularly multi-centre and multi-national clinical trials and, thereby to reduce the time to commencement. However, an EU directive allows different interpretations to be made by Member States when implementing it into national legislation, and accordingly significant differences between the countries were the result. Applicants are therefore still confronted with significant problems to comply with country-specific requirements, particularly when planning multi-national studies.

Given the various EC systems and corresponding application requirements it is crucial for sponsors to have unrestricted and easy access to up-to-date information on the conditions in the different countries. Therefore, the main aim of this thesis was to investigate which level of details on such requirements are available for the EU/EEA countries in the internet and additionally to assess whether a foreign applicant with just English language skills might be able to complete a valid application for ethical review in the respective countries. For that survey the report of the EFGCP Ethics Working Party which summarised the different EC procedures and particularities for most of the European countries was taken as a starting point. The results revealed that actual information on the application requirements have been made available in English language in about 63% of the Member States and that, based on the available details, a complete and valid application for ethical review seems possible in only nine countries.

Furthermore, a country-by-country comparison of the application requirements obtained from the website survey against those specified in the corresponding country tabulation of the European detailed guidance on EC procedures (ENTR/CT2) was carried out. This yielded a number of deviations and therefore the validity and reliability of the country tabulation in the detailed guidance is called into question. On the other hand, this confirms again the high importance for applicants to have unrestricted access to current EC application requirements in the different countries as mentioned above.

The findings of the examinations described in this master thesis clearly confirm that one of the main objectives of the Clinical Trials Directive, namely to harmonise the procedures for ethical review of clinical trials and to reduce the administrative burden, has still not been achieved. Furthermore, it has become obvious that even though a considerable amount of information on the EC application requirements are available in English in a number of European countries, it is currently not possible for foreign applicants to fully undertake the EC applications in most of them. In fact, nowadays the only way to complete the ethical review process successfully is to go back to consultancies/CROs with specific knowledge about the conditions in the desired countries.

Given the fundamental principles of the EU with its common market, the current situation is dissatisfactory as the conduct of clinical trials may be negatively affected in some EU countries. As a consequence, interested patients might not be given the opportunity to participate in studies with promising new drug treatments, thereby raising ethical questions again. Moreover, the development of new medicinal products might be delayed. To improve the situation, it is necessary that all relevant EC application requirements should be made available in an unrestricted and structured way by all countries. Finally, the harmonised principles of GCP and underlying ethical considerations call for a further EU-wide harmonisation of requirements for ethical review of clinical trials with medicinal products.

Pages: 52, Annexes: pages: 48