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The overwhelming importance of clinical trials

Submitted by on 17 Feb 2011 – 15:32

By Commissioner John Dalli

Clinical trials are an indispensable part of clinical research which, in turn, is essential to develop medicinal products, and to develop and improve medical treatment. Whether aimed at improving the use of existing medicines, or at developing new medicinal products, clinical trials are key to strengthening knowledge, innovation and public health.

In the present context of public budget constraints, major demographic changes and increasing global competition, clinical trials can not only lead to medical breakthroughs but can help address major societal challenges such as age related diseases affecting the ageing population whilst at the same time contribute to economic growth and a healthy labour market.

Indeed, innovation is central to the Europe 2020 strategy for smart, sustainable and inclusive growth, published in March 2010 and approved by the European Council in June 2010: One of the seven flagship initiatives announced as part of the Europe 2020 strategy is the Innovation Union aiming to improve the conditions and access to finance for research and innovation, to ensure that innovative ideas can be turned into products and services that create growth and jobs. By spending three per cent of GDP on research and development by 2020, it is projected that the EU could create 3.7 million jobs and increase GPD by close to €800 billion by 2025.

The Innovation Union proposes the creation of a series of European Innovation Partnerships to test a new approach to accelerating EU research and innovation. A pilot European Innovation Partnership in the field of active and healthy ageing aims to improve the quality of life of an ageing population, for example, by developing new innovative solutions, clinical tests, diagnostics and treatments for age-related diseases, deploying new innovative ICT-based solutions and introducing products, appliances and services tailored to the elderly. By fostering these innovations, the Partnership seeks to increase healthy life years by two.

Research, resulting in new medicines for the elderly, new treatments or diagnostic tools, and new solutions allowing for better quality of life is central to better ageing. Europe has no shortage of potential for achieving this. We have world leading researchers, entrepreneurs and companies and unique strengths in our values, traditions, creativity and diversity. However, unsatisfactory framework conditions, such as disproportionate administrative requirements present serious handicaps to companies choosing where to invest and conduct research around the world. The time has come to set the correct framework conditions; improving the regulatory framework for clinical trials is fundamental to this.

Since 2004, clinical trials performed in the EU have been regulated by the Clinical Trials Directive. The primary purpose of this Directive and its implementing measures is the reliability of data generated in trials, and the protection of the health, safety, rights and wellbeing of clinical trial participants.

In part, the Directive has been successful in fulfilling this purpose. It is now well established that the Clinical Trials Directive has brought about important improvements in safety and ethical soundness of clinical trials in the EU, as well as in the reliability of clinical trials data. For example, at a Commission/European Medicines Agency clinical trials conference in October 2007, a large majority of attendees acknowledged that the Clinical Trials Directive had resulted, overall, in better protection of clinical trial participants.

However, achievements have been accompanied by considerable criticism that the Clinical Trials Directive has hindered the attractiveness of patient oriented research in the EU, which greatly reduces Europe’s competitiveness in the field of clinical research and in turn hampers the development of new and innovative treatments and medicines. In particular, the harmonising effect of EU-legislation in the field of clinical trials has been insufficient. Today, the regulatory frameworks throughout the EU are similar, but not harmonised. This makes the conduct of clinical trials in the EU expensive and burdensome, without corresponding benefits in terms of patient safety, patient availability and data robustness.

Indeed, while, in 2007, there were approx. 5.000 requests for authorisations of clinical trials (involving approx. 530.000 participants), this figure has dropped, in 2009, to approx. 4.500 requests (involving approx. 350.000 participants). This is not a reassuring trend and we have to assess how a review of the Clinical Trials Directive can help to reverse this trend and make a better contribution to the attractiveness of Europe for pharmaceutical clinical research.

The European Commission is thus planning to adopt, in 2012, a proposal for a review of the rules governing clinical trials. The objective is to revise the Clinical Trials Directive to address the shortcomings identified in evaluations conducted by the Commission in previous years. To this end, a number of consultations in different fora are ongoing and planned. Extensive consultation is particularly crucial in this file, as it does not only concern industry-driven research, but all clinical trials conducted in the EU. There are also a considerable number of patients groups that have solid experience on this issue and that will certainly enrich the process of consultation. Given the range of stakeholders, it is therefore crucial to the success of the consultations that all stakeholders make their voice heard.