Press release on registration of randomised controlled trials

This Communiqué  reiterates the recommendations on registering clinical trials made in the 2001 ESF Briefing on Clinical Trials, notes that these recommendations can not be met through the confidential register of drug trials being established through the European Clinical Trials Directive, and asks ESF member organisations to proceed without further delay in establishing national, publicly accessible registers of all non-commercially funded, ongoing randomised controlled trials.  Progress towards this objective will be assessed by ESF in the summer of 2003, with a follow-up meeting in the autumn of 2003.

In May 2001, the European Science Foundation (ESF), strongly encouraged by its Member Organisations, in particular its European Medical Research Councils Standing Committee (EMRC), issued a wide ranging Policy Briefing on Controlled Clinical Trials(1) . A key element of the Briefing concerned the registration of planned, recruiting and unreported controlled trials, which, it was noted, is ‘essential for good financial management, good scientific practice and good ethical practice’.

Research funding agencies, as well as pharmaceutical companies, need to take their decisions in the light of reliable information about all studies, to avoid duplication of effort, to promote appropriate replication and to promote collaboration.

In addition, patients, health professionals, clinical researchers, members of ethics committees and other decision-makers need to be informed about trials in which they can participate, or to which they can contribute in other ways.

For more than ten years, registration of all randomised controlled trials has been a matter for discussion among and between sponsors, health authorities, investigators and research ethics committees, as illustrated by the 1993 consensus report of the International Collaborative Group on Clinical Trial Registries(2) . This publication proposed comprehensive registration of all randomised clinical trials (single centre and multicentre, small and large) as the best means of disseminating the fact that these studies were being performed.

These and other similar recommendations and regulations have only begun to be implemented, mainly in the USA go to website and the United Kingdom go to website . Through the European Clinical Trials Directive, the European Union has recently introduced legislation requiring registration of ‘clinical trials on medicinal products for human use’ in a European database.  However, the information in this database (EUDRACT) will be confidential, restricted to the Competent Authorities, the European Commission and the Member States.  EUDRACT does not, therefore, meet the need for freely available public information about all ongoing clinical trials in Europe, as increasingly being achieved with the registers in the US and UK, and as recommended in the 2001 ESF Policy Briefing.

In November 2002, the ESF convened a meeting in Frankfurt to review progress in the implementation of its recommendations to its Member Organisations, which were

• Support registration activities in their countries and provide the infrastructure for consolidating national registers at a pan-European level

• Require registration as a condition of releasing funds for supporting randomised trials

• Contribute core data items from their registers of randomised controlled trials to the international metaRegister of Controlled Trials at: go to website 

• Support the development and use of an International Standard Randomised Controlled Trial Number (ISRCTN – go to website 

• Encourage national ethics committees to require registration of all studies prior to assessment

The importance of the ESF meeting was underlined in a high profile editorial in the British Medical Journal (3).  Participants at the meeting reiterated that increased openness about clinical research resulting from implementation of these ESF recommendations should help to build trust between the public and the medical research community and help to improve the quality and relevance of clinical trials in Europe.

Although it was noted that some encouraging progress has been made in implementing the ESF recommendations, this has been patchy.  Participants at the meeting emphasised that the ESF objectives of transparency, comprehensiveness and public access will not be achieved through the clinical trials register being established by the European Clinical Trials Directive (EUDRACT). They reaffirmed the recommendations in the ESF’s 2001 Briefing, and agreed unanimously on the necessity to proceed to establish national registries of  all non-commercially funded randomised trials, regardless of the type of health care intervention being evaluated (that is, not restricted to drugs).  The information in these registries should be simple, reliable, and freely accessible to the public.

The ESF, represented by its EMRC Committee, now calls upon its Member Organisations and the ministries of health within its member countries to implement the recommendations in its 2001 Policy Briefing, using whatever levers and opportunities are most appropriate in individual countries.  In the summer of 2003, ESF will survey its member organisations to assess progress in implementing the recommendations.  A follow-up symposium will be held in the autumn of 2003, at which ESF Member Organisations will be able to exchange experience and present their action plans/timetables for further progress.

Contact for further information: 
Dr. Marianne Minkowski

1. European Science Foundation Policy Briefing N°13, May 2001
2. Clinical Trials and Meta-Analysis, 28 (1993) 79-80
3. British Medical Journal, 325 (2002) 1314-1315  www3.esf.org/newsrelease/60/bmj.pdf

Category: Media Centre, Press Releases 2003