As the draft of the new EU Clinical Trials Regulation is poised to enter Triologue discussions, BioMed Central has thrown its support behind the AllTrials initiative and has written to the British Secretary of State for Health, Jeremy Hunt, urging him and the British Government to support amendments to the European regulation on clinical trials that would mean more of the findings from clinical trials done in Europe will be available to researchers and doctors.
The benefit of making results of all clinical trials accessible to researchers, clinicians and the public, to promote transparency and make the best evidence available for informed clinical decision making, is self-evident. However, while there is wide-spread support for trial reporting and transparency, only around 50% of all clinical trials are currently published, making their findings inaccessible to doctors and researchers.
BioMed Central has long been an advocate for trial registration and, in line with the International Committee of Medical Journal Editors (ICMJE) policy, all BMC journals that publish randomised controlled trials, such as the journal Trials and flagship title BMC Medicine, require all clinical trials to be registered in a publicly-available registry approved by the World Health Organization (WHO), such as the International Standard RCT Number (ISRCTN) register. We also allow retrospective trial registration and encourage publication of negative results and unfinished studies, so that all results can be reported and ensure that the published record is complete.
These new amendments to the EU Clinical Trials Regulation support these ambitions and would mean more of the findings from clinical trials done in Europe will be available to researchers and doctors. Specifically, the amendments call for the prospective registration of all clinical trials (Amendment 191), for the data in clinical trial reports to not be considered commercially confidential, so that commercial considerations don’t override the public interest (Amendment 30 and 250), and for any detailed clinical study report produced about a trial to be made publically available (Amendment 193 and 253).
During Triologue, the European Parliament, Commission and Council meet to negotiate their positions. The Council, which is made up of representatives from every national state Government, has not yet decided its position; therefore, BioMed Central encourage all supporters of the AllTrials initiative based in an EU country to follow our example and write to their country’s Government, urging them to support the good progress being made towards clinical trial transparency in the Regulation.