The European Commission requires all clinical trials results are posted on the EU Clinical Trials Register (EUCTR) within 12 months of completion and within six months for trials involving children, however, according to a report published on 12 September in The BMJ, a prominent medical research journal, just under half of the registered clinical trials in Europe are meeting this requirement.
The research assessed the compliance with the EU requirement to post results of all trial on the registry in order to highlight factors associated with non-compliance and identify individual trial sponsors that are best at complying. In addition, the reporting status of every individual trial conducted in Europe and overall performance rankings for every sponsor are now available on online as part of an openly accessible created live searchable web resource updated each month. to give ongoing
According to the research, carried out by the DataLab at the University of Oxford and based on records for all 31,821 trials registered in the EUCTR since 2004, of the 7274 completed trials on the database due to report their results, only 49.5% have done so ― 68.1% of trials sponsored by pharmaceutical companies reported results within 12 months compared to just 11% of those sponsored by universities, hospitals, government, and charities.
Pharmaceutical companies were found to be much better at complying with reporting rules ― eleven major commercial sponsors achieved 100% compliance, including Gilead Sciences, Almirall, Genentech, and Vertex Pharmaceuticals ― than non-commercial sponsors such as universities, hospitals, and charities. Whereas a number of non-commercial organisations such as Cancer Research UK have also achieved compliance, 32 large sponsors responsible for 50 or more trials, all European hospitals, universities, and research institutes currently conducting trials. The worst offenders were universities including the Charité University Hospital in Berlin and the Ludwig-Maximilian University (LMU) Hospital in Munich, Germany, and Karolinska Institute in Stockholm, and combined have not reported any due results on 110 trials in total listed on the database, as the paper says.
So, why are these major institutes failing to comply? The study authors suggest the widespread poor compliance practices within universities and other non-commercial may be owing to a lack of clear lines of responsibility. Another reason may that staff who were involved in the trials have moved to other jobs or maybe retired. They called for policies to ensure compliance with the EU regulations.
Jacob George, director of R&D at the United Kingdom’s National Health Service Tayside and professor of cardiovascular medicine at the University of Dundee ― which has a high compliance rate of 82% ― thinks reporting tasks “cannot be just thrust on researchers and universities.” In addition, researchers need to be assured that reporting their results on clinical trial registries will not exclude them from publishing the results in peer-reviewed journals.
According to the authors, the next step will be to use these regularly updated performance statistics to improve compliance so that trial results can have maximum impact. They write, “We hope that accessible and timely information on the compliance status of each individual trial and sponsor will help to improve reporting rates.”
(1) Goldacre, B. et al. Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource. BMJ (2018). DOI: 10.1136/bmj.k3218