Thérapie 2010 Juillet-Août; 65 (4): 301–308

Regulatory system

Clinical Trials Legislation - Preparing for the Revision of the European Directive Scheduled for 2011

¹ Laboratoire Boehringer Ingelheim, Reims, France
² Afssaps, Saint-Denis, France
³ Centre d’Investigation Clinique, Hôpital Jeanne d’Arc, Dommartin les Toul, France
⁴ Direction Générale de la Santé, Paris, France
⁵ Laboratoire Pfizer, Paris, France

Correspondence and offprints : Pascal Bilbault, Recherche Clinique Boehringer Ingelheim France, 12 rue André Huet, 51060 Reims Cedex, France. E-mail: pascal.bilbault@boehringer-ingelheim.com

Received: 29 March 2010
Accepted: 23 April 2010

Abstract

The aim of the Round Table was to make recommendations with regard to the imminent revision of the European Directive on clinical drug trials (2001/20/CE). While recognising the importance of compliance with this Directive, which is not optimal in some member states of the European Union, it would be constructive to simplify further and harmonise its application in every country. Without necessarily resorting to a revision, some of the Directive’s dispositions could be improved, such as the definition of “investigational medicinal products” (IMP) and what should be considered as “substantial amendements”, as well as harmonising and improving the way in which Ethics Committees are run, either on a European Commission level, or by relying more on the European Network of Research Ethics Committees (EUREC) which already exists in several European member states.

Other points in the Directive do require revision, especially those relating to:

• the definition of the respective roles of Ethics Committees and Competent Authorities,

• the simplification of safety information to Ethics Committees (giving them access to the Eudravigilance database for adverse reactions occurring during clinical trials and providing them with only new safety issues or with a summary of the Annual Safety Report),

• the possibility of one single European authorisation for the trial, centralised and/or decentralised, when the trial is multinational.

The recommended changes could be made within the scope of a European Regulation, avoiding the need to transpose it at a later date into each country’s regulations, which is a source of possible lack of harmonisation. More specifically, for trials with institutional sponsors and/or investigator driven trials such as “drug therapy strategy trials”, modulating restrictions according to the “risk added by the research” would enable the trial’s organisation to be simplified regarding monitoring, adverse reactions reporting and study drugs labelling.