Brussels, 17 Feb 2003
The European Science Foundation (ESF) claim that they cannot meet their objectives of providing Europe with transparent and comprehensive public access to all clinical trials due to the recently established European Clinical Trials Directive (EUDRACT).
The EUDRACT database was set up as a result of Directive 2001/20/EC to provide Member State authorities with information on the safety of medicines used in clinical trials.
The security standards that apply are those set by the European Commission for the operation of secure networks for regulatory authority communication. Access to the database is restricted to competent authorities of the Member States, the European agency for the evaluation of medicinal products (EMEA) and the European Commission.
However, sponsors who submit information do not have access to the database itself or the information held in it. This contrasts greatly to the US and UK where registers are more in line with the ESF briefing.
Increased openness about clinical trials between the public and the medical research community would help to improve the quality and relevance of clinical trials in Europe, suggest ESF members.
Further arguments in favour of more public access include the fact that research funding agencies, as well as pharmaceutical companies, need access to reliable information about all studies in order to make the right decisions.
Disseminating clinical trial results to a larger audience would not only avoid duplication, but would promote appropriate replication and collaboration.
Furthermore 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, argues the ESF.
The ESF and the European medical research council committee now appeal to its member organisations to establish national registers of all non-commercially funded clinical trials that are publicly accessible.
For further information on the directive, please click here
For further information on the ESF position, please visit:
http://www.esf.org/esf_pressarea_page.ph p?section=6&language=0&newsrelea se=60