EU Trials Come Under Security

The planning and performance of clinical trials in the European Union is needlessly complex as a result of legislation introduced in 2004, and the changes have not led to a significant increase in the safety of subjects and the quality of data.

The EFGCP's Ingrid Klingmann, MD, from Pharmaplex will wrap up the workshop.

That's the stark view of the European Forum for Good Clinical Practice (EFGCP), and it's prompted the influential think-tank to implement a concerted plan of action to simplify and improve the current system. It has devised a "road map initiative for clinical research," which will be discussed at a multidisciplinary workshop in Brussels on March 17.

According to a statement issued by the EFGCP: "Many clinical researchers complain that important trials are not being performed due to the complexity and related costs of clinical trial organization in the current environment. Research on the impact of the regulatory requirements like the ICREL (Impact on Clinical Research of European Legislation) project has provided reliable data on the current situation and encouraged the need for developing solutions."

The EFGCP has identified five areas that require urgent attention: a single clinical trial authorization (CTA), co-sponsorship of trials, risk-based approach, ethical review, and safety reporting. It has drawn up proposals in each of these areas, and they will be discussed in-depth at the Brussels workshop. At the meeting, priorities will be set and a list of items will be prepared for the European Commission to radically improve the situation.

New legislation may be required, or at least changes to the current legislation and/or adaptation of the current guidelines for implementation in the member states, according to EFGCP. Debate will focus on two central questions: Can we agree on the key elements of a future legislative environment for clinical research in Europe? What recommendations should be made to the European Commission?

The roadmap initiative includes representatives of academic and not-for-profit organizations who are keen to investigate different aspects of research in Europe following implementation of the Clinical Trials Directive (DIR 2001/20/EC) and to promote academic trials. They have so far identified these potential solutions:

• To require only one CTA, irrespective of the number of participating nations, either by the development of a single CTA application or the mutual recognition of authorizations
• To simplify and harmonize the procedures for trial approval (e.g., the EudraCT forms as a single set of forms to be completed) and safety reporting (Eudravigilance and reporting rules)
• To define better and harmonize the roles of ethics committees and achieve a "single opinion"
• To adopt a risk-based approach: adaptation of regulatory requirements that consider the risk associated with the trial with regard to safety reporting (e.g., limited safety reporting for commercially approved drugs), data monitoring, insurance, application dossiers, substantial amendments, and free supply of drug (e.g., not in case of market approval)
• To allow co-sponsorship in the case of multinational trials, with the aim of facilitating collaboration between research groups
• To better define terms and concepts (investigational medicinal products, interventional studies, substantial amendments, etc.)
• To increase public financial support of investigator-led trials
• To harmonize insurances requirements, e.g., uniform costs per country, minimum and maximum indemnity payments, total duration of coverage, and time-to-permit claims.

More information is available at www.efgcp.be.—Philip Ward