ICREL Assesses EU Trials Directive

The EU Clinical Trials Directive has garnered much criticism since its implementation in 2004. Many clinical research professionals feel that the Directive—created to improve patient protection, harmonize European clinical trials, and boost the quality of research—has hindered progress instead of aiding it.

Sample page from the ICREL survey designed specifically for commercial sponsors who conduct trials in the EU.

Thus, in an attempt to analyze the impact of the Directive, a consortium created by the European Forum for Good Clinical Practice (EFGCP) and comprised of the European Clinical Research Infrastructure Network (ECRIN), the European Organization for Research and Treatment of Cancer (EORTC), Ethics Committee of the Medical University of Vienna, and Hospital Clinic I de Barcelona, established the Impact on Clinical Research of European Legislation (ICREL), a one-year project stemming from DG Research's desire to acquire data on the effects of the Directive.

On May 30, 2008, ICREL launched an online survey that allows stakeholders to share their experiences with the Directive. The data collected through the survey will provide a basis for objective analysis of the Directive's consequences in all aspects of clinical research and will allow for the ICREL project members to identify areas for improvement.

"ICREL is not only supposed to give data but also examples of best practices," said Ingrid Klingmann, ICREL project coordinator and EFGCP member, to Applied Clinical Trials. "By participating with their information, stakeholders have a unique chance to demonstrate the problematic areas to the European Commission and have a means to encourage change in direction of their interests."

There are four variations of the survey—formulated by groups called Work Packages, which organized the project—based on stakeholder category (commercial sponsor, noncommercial sponsor, ethics committee, competent authority) as the Directive's impact varies among different stakeholders.

"We were very clear from the beginning that all stakeholders in the clinical research process needed to be included," explained Klingmann. "The only group we have not involved with a dedicated questionnaire are patient organizations. But their issues are included in the Work Package Ethics committees and are dealt with in nonstructured surveys and interviews."

The Work Packages ensured that each survey was tailor made to deal with distinct topics the various stakeholders encounter while working within the Directive's framework. The stakeholders can use the questionnaires to weigh in on the difficulties such topics have caused for them and propose ways in which they can be changed for the better.

"ICREL is not intending to improve anything but to give objective information," Klingmann clarified. "With the selection of the stakeholders and acceptance of the project plan by the European Commission when they awarded the project to our consortium, there is an implication that these areas are open for discussion on the need for change."

For the project to have any real effect, however, ICREL needs as much input as possible. Aside from spreading the word through mailings to the consortium members' databases, giving interviews, and displaying their material at industry events, they have been publicizing the surveys by asking organizations to link to it from their Web sites and send out mailings. The survey will be accessible through July 20, and the results will be compiled and used in conjunction with earlier surveys, existing databases, and information from publications that also examined the effect of the Directive. The findings will be discussed at a conference in Brussels, Belgium, on December 2, 2008.

ICREL encourages anyone affected by the Directive to complete the survey. To do so, please visit www.eortc.be/icrel.—Samantha Etkin