In response to a European Commission consultation on the EU Clinical Trials Directive, the European CanCer Organisation (ECCO) has supported proposals by its member organisations for adapting the Directive's requirements to reflect practical necessities in cancer research and treatment.

Since the implementation of the Directive in 2004, ECCO and its member organisations have been concerned about the detrimental effect it has had, particularly on international clinical trials and those that are headed by hospitals, universities, cancer networks and other non-commercial institutions. Lack of harmonisation between European countries in the implementation of the Directive and the increased costs and workload of setting up and running trials has meant that many international trials not aiming at registration of a compound have taken much longer to get started, or, in some cases, have had to be abandoned before start up because of the insurmountable hurdles they faced. At the same time, the Directive does not appear to have improved patient safety in clinical trials or the quality of science.

ECCO’s member organisations, including the European Organisation for Research and Treatment of Cancer (EORTC) and the European Society for Paediatric Oncology (SIOP Europe), have responded to the Commission’s consultation with a number of proposals for improving the Clinical Trials Directive (2001/20/EC). These include:

• Reducing the bureaucracy, workload, and, therefore, the costs, of setting up and running clinical trials by harmonising procedures across all member states, including harmonising and refining the definitions of what is a “clinical trial” and an “investigational medicinal product”;
  
  
• Harmonising the interpretation of rules to avoid confusion over interpretation of “local rules” by competent authorities and Ethic Committees in different countries;
  
  
• Clarifying the role of the clinical trial sponsor (and co-sponsor) – the need for a single, pan-European sponsor is interpreted differently by national regulatory authorities and has caused severe delays to the launch of new protocols by long-established European collaborative groups, such as those involved in paediatric oncology;
  
  
• Requiring a single Clinical Trial Authorisation (CTA), irrespective of the numbers of participating countries, either by the development of a single CTA application, in English, across Europe or a mutual recognition process;
  
• Streamlining the process of gaining ethical approval, possibly by having a single Ethics Committee per Member State, rather than the several in existence currently;
  
• Simplifying the process of making amendments to trials;
  
• Improving and harmonising the way risk in a clinical trial is assessed so that it takes account of occasions when an investigated treatment is already considered “standard of care” and therefore should be “zero-rated” for the purposes of the clinical trial;
  
• Improving and harmonising the way in which insurance for a trial is calculated according to medically sound evaluation of risks;
  
• Streamlining and harmonising the way suspected unexpected serious adverse reactions (SUSARs) are reported;
  
• Taking into account the special needs of groups of patients with rare cancers or particular needs, such as children and the elderly;
  
• Adapting the extent of monitoring according to the risk associated with each trial;
  
  

Michael Baumann, M.D., Ph.D., President of ECCO and Professor of Radiation Oncology, Director of the Clinic of Radiation Oncology and one of the directors of the Comprehensive Cancer Centre at the Medical Faculty Carl Gustav Carus, University of Technology (TUD) (Dresden, Germany), said: “ECCO has been aware of significant problems with the EU Clinical Trials Directive ever since its implementation by Member States in 2004. Our greatest concern remains the negative effect it has had on patients, their safety and their health.

"While the aims of the Directive were laudable – to harmonise clinical trials across Europe and improve patient safety – the reality has turned out to be quite different. It is generally acknowledged that the Clinical Trials Directive has had a catastrophic effect on the independent evaluation and comparison of drugs and other therapies by academic clinical researchers. It has greatly reduced the amount of academic clinical research in oncology in Europe in all treatment categories (surgery, radiotherapy and systemic medicinal therapy) and in their combinations.

"Certain groups of patients have been particularly hard hit: children, patients with rare cancers, patients who would profit greatly from international trials that optimise already existing treatments and which, therefore, do not find commercial sponsorship, and elderly patients with other health problems, including secondary cancers due to earlier treatments.

"ECCO is contributing to the Commission's consultation on the Clinical Trials Directive by whole-heartedly supporting and endorsing the individual submissions made by its member societies such as SIOP Europe and EORTC.

"We hope the Commission's consideration of all the submissions made to its consultation on the Directive will result in a reform of the Directive that really does lead to an improvement in investigators' abilities to conduct research into important questions in cancer treatment, for the benefit of patients and the competitiveness of European research.”

The European Commission launched a public consultation paper on the assessment of the functioning of the EU Clinical Trials Directive on 9 October 2009, with a January 2010 deadline for submissions. Now the Commission will consider the responses and either draft amendments to the Directive or draft a new Regulation to replace the Directive, probably some time in the summer this year.