End clinical trials ‘chaos’ with register, says BMJ
pharmafile | October 23, 2003 | News story | |
The British Medical Journal has called for all clinical trials within Europe to be registered in a central database.
The journal, which has been campaigning for such a scheme for several years, says the lack of a trials register has resulted in a "chaotic" research environment, duplicated research effort and biased treatment decisions.
"It is impossible to find out, even with inside knowledge, who is studying what", the BMJ editorial comments. "This means that patients and their doctors don't know about trials they could take part in, researchers don't know if someone has already started a trial they want to do, funding bodies and governments can easily set research strategies (because they don't know what going on), and research that never published disappears without a trace".
While some national registries exist, their restrictive and limited nature does little to co-ordinate research across Europe. In February, the European Commission decided not to provide funding for a central European register, which means the substantial costs of any scheme must be passed on to participating organisations in order to provide free access to users.
The EUDRACT database, set up as part of the EU Clinical Trials Directive, will not be sufficient, adds the BMJ, given that it only covers drug trials, rather than a variety of medical interventions, and full access is restricted to regulatory authorities only.
While trial registration in the US is mandatory, it is limited to serious or life threatening diseases.
The BMJ says the most promising development is the meta-register of controlled trials, established by the publishing company Current Controlled Trials. Each trials submitted, from organisations such as the MRC, the NHS and medical charities, is assigned a unique international standard randomised controlled trial number (ISRCTN).
GlaxoSmithKline, Schering Health Care and Laxdale Ltd are the sole pharma companies to contribute, however, despite the recommendations of the ABPI.
The European Science Forum, which brings together national research councils, has also urged its members to join the meta-register, and intends to monitor progress in six month's time. It suggested one way of increasing membership would be to only guarantee funding once a trial was registered.
