A risk-based approach to regulation and streamlined approval procedures are among the key recommendations in a new report that addresses the obstacles to non-commercial, investigator-driven clinical trials (IDCT) in Europe.

The report is the outcome of a Forward Look study undertaken by the European Medical Research Councils (EMRC) of the European Science Foundation (ESF). According to the Foundation, it represents “probably the most comprehensive examination of IDCT in Europe in recent years”.

The report draws on the findings of five strategic workshops organised around the themes of categories and design of IDCT; regulatory and legal issues, intellectual property rights and data-sharing; management of IDCT; education, training and careers, and authorship; and funding and partnership models.

A total of 88 recommendations emerged from this process, which were then refined to 26 recommendations on the advice of the Forward Look Management Committee. The final recommendations were ranked in order of priority following a consensus conference held in September 2008.

Clinical patient-oriented research is “under strain” in Europe for a number of reasons including demand for improved efficiency in healthcare systems that leaves little time for medical research, and the increasing bureaucracy involved in setting up clinical trials, the report notes.

Funding for IDCT “was and frequently still is lacking”, while the rules and regulations governing clinical trials are interpreted differently from one EU member state to the next, it says. In many countries there is also a perception that the attractiveness of patient-oriented research as a career has waned and there are not enough incentives for qualified personnel to enter the field.

A further issue is data ownership, particularly in respect of commercial clinical trials sponsored by the pharmaceutical industry. “While it is recognised that there are issues of intellectual property, the advancement of knowledge requires data to be shared and more needs to be done to address this,” the report comments. It also calls for a more robust infrastructure of research centres and clinical trial units to support clinical and translational medicine across Europe.

The five leading recommendations to strengthen IDCT in Europe, as ranked by the ESF’s consensus conference, were:

- Improve the education, training, and the career structure and opportunities for scientists involved in patient-oriented clinical research.
- Increase levels of funding for IDCT
- Adopt a risk-based approach to the regulation of IDCT
- Streamline approval procedures for IDCT
- Ensure that IDCT are carried out with appropriate numbers of patients to generate statistically reliable results, so that the trials are ‘correctly powered’.

The MHRA is listening

“We hope that these outcomes will be the beginning of interactive discussions between stakeholders and generate strategic planning and implementation of the recommendations so that better IDCT and clinical research will improve patient care and health in Europe and worldwide,” said Dr Carole Moquin-Pattey, head of the EMRC and co-ordinator of the study.

One stakeholder that has already committed to moving forward on the report’s proposals is the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

“The ESF report identifies and ranks 25 specific issues that need to be examined in the UK context,” commented MHRA chief executive Professor Kent Woods. “And we will work with colleagues in the Department of Health, the Medical Research Council and the academic sector to do that.”

While the UK has made “considerable progress” in streamlining the approval process for clinical trials – including a newly improved Integrated Research Application Scheme – there remains scope for further improvement in some of the other areas highlighted by the ESF report, the agency acknowledged.

“The UK continues to lead this type of research in Europe but we could do a lot more if critical obstacles were addressed,” Woods commented. “Some of these are regulatory, but not all. Some are also related to the infrastructure required to carry out clinical trials.”

The MHRA also noted that the European Union’s clinical trials directive, 2001/20/EC, is up for review by the European Commission in 2010 and that there is “strong support expressed in the ESF report for a more flexible and ‘risk-based’ legal framework”.

The number of clinical trials approved in the UK has remained quite stable since Directive 2001/20/EC was implemented in May 2004, totalling 1,085 in 2005, 1,206 in 2006, 1,218 in 2007 and 1,252 in 2008. Currently there are some 3,000 trials active in the UK, 25% of which are non-commercial and 75% commercial, the MHRA reported.

Despite perennial complaints about the bureaucratic burden of conducting clinical trials under Directive 2001/20/EC, the new rules “actually simplified the approvals process as it made it a legal requirement that approvals were needed from only a single ethics committee and the Competent Authority (MHRA in the UK) in each EU member State involved in a clinical trial”, the agency pointed out. “This contrasts with the situation in the UK prior to May 2004 when multiple ethics committee approvals were needed for many trials.”