Results are missing for over two hundred drug trials involving Swedish patients
Major Swedish universities, hospitals and pharmaceutical companies have failed to fully make public the results of an estimated 277 clinical trials, a new report released today warns.
The results of some of those trials, including a trial involving patients suffering from an especially lethal form of cancer, appear to never have been made public anywhere.
Out of the 22 largest trial sponsors, only two have made all of their due trial results public on the European trial registry within a year of trial completion, as required by EU transparency rules. Overall, trial reporting rates in Sweden are far below the average in other European countries, to the detriment of Swedish patients and taxpayers.
On the positive side, Karolinska Institutet, Uppsala University and the University of Gothenburg have already pledged to tackle the problem. Karolinska – by far Sweden’s largest medical research institution – has set a particularly strong positive example. It is already uploading all its missing results onto registries, including the results of trials that are currently not subject to mandatory disclosure requirements.
The chart below shows the current reporting performance of Sweden’s largest trial sponsors.
Key Swedish bodies appear to be doing little to promote transparency and curb costly research waste:
The Swedish Medical Products Agency (Läkemedelsverkets) appears not to be following up with trial sponsors whose results are overdue or whose registry entries are inaccurate
The Swedish Research Council (Vetenskapsrådet) has not yet committed to implementing WHO best practices to ensure that all trials it funds make their results public
The report recommends that the Swedish government should review the UK’s national clinical trial transparency strategy and explore the possibility of adopting a similar approach in Sweden.
Matteo Bruschettini, Director of Cochrane Sweden, said:
“Cochrane Sweden promotes initiatives to improve the reporting of all studies. Our hope is that this report and the linked implications and recommendations can help to facilitate improved reporting of clinical trials within Sweden. We share the goal to get more complete and accurate evidence on which to make informed health decisions within healthcare, and better health for everyone.”
Till Bruckner, founder of TranspariMED, said:
“Clinical trials whose results remain invisible are a waste of money, a betrayal of the trust of the volunteers who participated in these trials, and a threat to public health. The pledges by leading universities to embrace transparency are good news for taxpayers and patients. The Swedish Medical Products Agency should urgently reach out to trial sponsors and assist them in making their clinical trial results public as rapidly as possible, before results are lost forever and become research waste.”
The full report can be accessed below:
Swedish universities and hospitals can use TranspariMED’s collection of transparency tools to guide efforts to improve their performance.