gms | German Medical Science

27. Deutscher Krebskongress

Deutsche Krebsgesellschaft e. V.

22. - 26.03.2006, Berlin

Clinical Research in Oncology - Experiences with the EU Clinical Trials Directive and Consequences for a Pharmaceutical Company

Meeting Abstract

  • corresponding author presenting/speaker Ulrike Haus - Novartis Pharma GmbH, Nürnberg, Deutschland
  • Karin Heidenreich - Novartis Pharma AG, Basel
  • Heinz Gebbing - Novartis Pharma GmbH, Nürnberg
  • Joachim Brom - Novartis Pharma GmbH, Nürnberg
  • Bodo Wahlländer - Novartis Pharma GmbH, Nürnberg

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocIS044

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter:

Veröffentlicht: 20. März 2006

© 2006 Haus et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen ( Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.



The European Unions (EU) Directive 2001/20/EC and its accompanying directives and guidance aim at approximating laws, regulations and administrative provisions relating to the implementation of Good Clinical Practice and Good Manufacturing Practice in the conduct of clinical trials on medicinal products. Objectives are the harmonization of the requirements for good clinical practice in the EU and to provide transparency on clinical trials with the EudraCT database and safety reports (SUSAR database). There is hope that the patient safety will be improved by these measures. The scope of this directive are all interventional clinical trials (Phase I-IV) with at least one study centre in the EU. Each study needs an EudraCT number and listing in the EudraCT database, a Clinical Trial Application to both the Competent Authority (CA) and the ethics committee (EC/IRB) with an approval of the study request within max. 60 days. An IMPD (Investigational Medicinal Product Dossier) containing quality, non-clinical and clinical data is needed and annual safety reports (ASR) are to be written. New guidelines for the batch certification of the study medication by a Qualified Person (QP, located in EU) have to be in place. The batch release requires batch certification by QP, positive votum by EC and approval by the CA. The consequences for a pharmaceutical company are the definition and establishment of new processes and communication lines between departments, monitoring of timelines for submission of the annual safety reports, new standard operating procedures, training and databases. There are new procedures needed for filling, sending, follow-up of clinical trial applications. New legal questions i.e. concerning the sponsor obligations in case of investigator initiated trials are to be solved. In conclusion, more resources are needed to perform a clinical trial. A real harmonization between the EU countries is not yet observed as national requirements still differ.