Reviewing ICR's Guide to the Clinical Trial Directives

Since its implementation in 2004, the CT Directive has received much criticism from both commercial and especially non-commercial trial sponsors for allegedly hindering rather than assisting the establishment and conduct of clinical trials in the European Union.

The principal purpose behind the CT Directive was to harmonize the regulatory environment and provide protection for trial subjects. However many accuse the legislators of failing to achieve any improvement.

The problems started with the implementation, where many member states appear to have tailored the directive to suit their own legislative circumstances.

For the many clinical trial workers who had personal experience of the step-change improvement in the performance and conduct of clinical trials arising from the global acceptance and implementation in the ICH GCP Guideline in 1997, the new EU legislation was a disappointment. A guideline which was sensible, pragmatic, clearly understandable, and worldwide was contrasted with regulations which were seen as verbose and disharmonious.

Within the non-commercial area there have been accusations of an unanticipated burden of red tape while the commitment to comply with GCP, in practice, has not been found to be uniform across national boundaries. However, it should be equally acknowledged that hospital funded researchers should have become involved in the early stages of the Directive’s introduction and implementation rather than waiting until the threat of inspection from the Regulatory Agencies.

Regarding the commendable intention to ensure adequate protection of trial subjects, it is noteworthy that the very serious near death adverse events seen in the TGN1412 trial occurred following the Directive’s implementation. Whilst this may be seen as just unfortunate timing, everyone should realize that legislation on its own is unlikely to make the world of clinical research any safer.

Variations between member states in both regulatory and ethical approval times and the practicalities of AE reporting, together with divergent requirements and interpretations from various member states, have led to increasing calls being made for a single and mutually-recognized CT authorization.

The Clinical Trial Directive 2001/20/EC, together with two other principal Directives and associated guidance documents, provide the most extensive changes in the European Union (EU) clinical trial legislation for many years. However, the EMEA has recently accepted that the Directive has not managed to promote as favorable a research environment as intended. The various member states would appear to have been allowed too much freedom to interpret and introduce differing format and language requirements during implementation into their own national clinical trial legislation.

This factually based publication, comprising 64 pages, provides a straightforward summary of the key aspects of these extensive legislative documents and gives the reader a useful overview which can be referred to when clarification is needed.

The author who has over 20 years experience in the clinical research industry has written this guide summarizing and explaining the context of each of the three linked European Directives. Directive 2005/28/EC, commonly and helpfully referred to as the GCP Directive, and Directive 2003/94/EC, known as the GMP Directive, are both cited within the Clinical Trial Directive 2001/20/EC

The author has painstakingly provided an up-to-date accurate summary of these three principal sets of regulations affecting clinical trials within the European Union. The guide is both an excellent introduction and training aid to the complexities of running clinical trials within the European Union and expertly explains the details of what is required by the legislators. The guide represents very good value for money.

Editor's Note: The Pocket Guide to the EU Directives for Clinical Research (ICR Publishing, The Institute of Clinical Research 2009), which covers the Clinical Trials Directive 2001/20/EC, GCP Directive 2005/28/EC, GMP Directive 2003/94/EC, was written by Dr. Julie Meeson, edited by Sue Fitzpatrick, and here has been reviewed by Nigel J. Crossland.

Nigel J. Crossland is QA director for Crossland Consultancy, Swettenham Village, Cheshire CW12 2LE, UK. He can be reached by telephone or fax at +44 (0) 1477 571001or by email at nigel.crossland@btinternet.com.