Reform of clinical trials directive must be future-proof

20 Feb 2013 | Viewpoint
Europe’s attempt to unify rules on clinical trials in the 2001 Directive is widely acknowledged to be a disaster. After years of debate, the Commission’s proposals for reform are getting a favourable reception, but it is critical the new regulation takes account of emerging technologies

Clinical trials are the lynchpin in translating Europe’s huge investment in biomedical research and delivering the latest medical treatments for the benefit of patients and for the good of the economy.

But it’s no secret that there has been a dramatic decrease in the number of clinical trials taking place in Europe over the last few years, with the finger pointed at the Clinical Trials Directive of 2001 as one of the chief causes of this decline.

The European Commission submitted its proposals for reform to the European Parliament and Council last year and on 28 January 2013; Rebecca Taylor MEP hosted a fact-finding roundtable, bringing together regulators and experts at the European Parliament to discuss the revisions which are currently under negotiation.

According to the Commission, the 2001 Directive has provided robust protection of drug trial participants, but it has caused many bottlenecks in the clinical trials system, especially multi-centre studies that require cross country cooperation. Administrative costs increased dramatically, resource requirements have doubled and delays have increased.

Slow and complicated procedures

According to an Impact Assessment by the European Commission, Europe today is not an attractive location for sponsors and investors of trials: The number of clinical trials applied for fell by 12 per cent from 2007 to 2011 (from 5,028 in 2007 to 4,400 in 2011). The procedures are slow, complicated and are not harmonised across member states.

Stakeholders from across Europe criticise the current directive for causing a, “significant decline in the attractiveness of patient-oriented research” in the EU. Today approximately 12,000 clinical trials are in progress in Europe, of which 25 per cent are multinational, involving more than three member states.

Dr. Richard Barker, Director of the Centre for the Advancement of Sustainable Medical Innovation, (a partnership between Oxford University and University College London) and former Director General of the British Association of Pharmaceutical Industries, told the meeting he welcomed the proposed reforms, but highlighted key transitions and technological advances which the new regulation must accommodate.

Defining diseases

The first is that clinical trials must evolve from defining diseases based on symptoms, to redefining them based on pharmacogenomics. Diagnostics and therapeutics need to be brought together to stratify patient populations to offer specific treatments pathways, based on the likelihood of a positive response.

The second transition will see real world data being harnessed through new tools and simulation processes to provide insights that will inform trial design. Currently, it is nearly impossible to construct Phase III trials that are large enough to completely eliminate safety issues, and the costs of such trials are unaffordable, particularly for SMEs.

Thirdly, the digitisation of clinical trials will enable patients to be more actively involved in the process. Historically, trial participants have often been treated as passive subjects, rather than being engaged actively to obtain more robust datasets.

To highlight the potential for improvements, Pfizer’s Senior Director for Clinical Development, Dr. Miguel Orri, presented results of their first “virtual” clinical trial using remote data capture and verification and electronic systems to feedback information to patients. Such developments can lead to a significant reduction in the cost of clinical trials, while providing more flexibility to the patients and doctors as well.

Make the trial fit the disease

The current “one-size-fits-all” mentality for drug trials must move to a much more adaptive approach to development and regulation of medicines.

Barker’s vision for the future would have  sponsors, regulators, health technology assessment agencies and patients come together to design clinical studies that respond to the unique nature of the therapy and the disease.

For the reforms to succeed, it is critical that the European Medicines Agency is open to new trial processes, and it is vital that Europe future-proofs the new clinical trial regulations to take account of new and emerging medical technologies.

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