This mission is achieved through collaboration in the development of new drugs and other innovative approaches, and through the evaluation of more effective therapeutic strategies testing currently approved drugs, surgery and/or radiotherapy in clinical studies. Driving international cancer clinical trials in Europe constitutes the daily work of the EORTC and has always posed multiple challenges. These challenges have become magnified and more complex since enactment of the EU Clinical Trials Directive 2001/20/EC (EU CTD) due to the multinational nature of EORTC clinical trials. Issued in May 2001 and enshrined into the national legislation of all EU Member States as of May 2004, the overall intent of this Directive was to create a clinical research environment across Europe conducive to the discovery of much-needed innovative medicines while simultaneously ensuring the protection of all clinical trial participants. Four years after coming into legal force, many believe that the original goals of the Directive have yet to be fully achieved.^2–6

Aim and Scope of the EU Clinical Trials Directive
The EU issues directives, a mechanism by which decisions made centrally are implemented at the Member State level. The aim of any directive is the harmonisation of fundamental principles and core procedures. However, a directive itself does not specify the means or methods for accomplishing this goal. The EU CTD 2001/20/EC is a directive on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice (GCP) in the conduct of clinical trials on medicinal products for human use.⁷It endorses the 1996 International Conference on Harmonisation (ICH) recommendations for GCP, the foundation for the Directive and its provisions.
The fundamental aims of the EU CTD are:

• to protect the rights, safety and wellbeing of clinical trial participants;
• to simplify and harmonise the administrative provisions governing clinical trials; and
• to establish a transparent procedure to harmonise the conduct of clinical trials in Europe and ensure the credibility of research results.

These are sound fundamentals. However, the Directive does not distinguish between commercial and non-commercial clinical trials – that is, between trials conducted by the pharmaceutical industry to register a new compound and trials carried out primarily by academic researchers. Under the EU CTD, all interventional clinical trials that involve medicinal products must meet new legal obligations. To the detriment of independent researchers, the Directive failed to take into consideration the unique nature of non-industry-sponsored clinical trials. Reprieve was found in recital 14 to the Directive, which specifically recognised noncommercial trials conducted by researchers without pharmaceutical industry support. However, application of the Directive remains fraught, with time-consuming, costly bureaucratic requirements.