The Swedish Research Council has pledged to improve clinical trial reporting by its grantees. The announcement comes in the wake of a report by Cochrane Sweden and TranspariMED showing that over two hundred clinical trials run by Swedish institutions have failed to make their results public as required by European transparency rules.
According to the Swedish magazine Curie, the Swedish Research Council currently does not explicitly require researchers it funds to make the results of their clinical trials public. (The Council does require grantees to adhere to the Declaration of Helsinki, according to which all trial results must be made public, but that message appears not to have filtered through.)
Madeleine Durbeej-Hjalt, the general secretary for medicine and health at the Swedish Research Council, told the magazine that:
"[W]e see that few [of our grantees] report and publish [trial results] and we intend to begin a review of what we can do to get more people to report. We think it is important both to report [on trial registries] and to publish [in academic journals]."
The Council is one of the top medical research funders worldwide, with a funding volume of $178 million in 2013.
The Swedish Research Council has not yet joined other major funders in signing up to the WHO Joint Statement, which commits funders to curbing research waste and monitoring their grantees' trial registration and reporting.
The original signatories to the statement include the Gates Foundation, Wellcome Trust, Inserm, and the Research Council of Norway. Last year, the Canadian Institutes of Health Research and the Health Research Council of New Zealand also signed up.
It is unclear what action, if any, the Swedish medicines regulator is planning to take.
According to Curie magazine, the Swedish Medical Products Agency is still not following up with trial sponsors to ensure that the results of drug trials are reporting as required by European transparency rules.
Matteo Bruschettini from Cochrane Sweden commented that:
"Sometimes we find studies but not the results. This means that we do not get the whole picture. If, for example, a study has been interrupted because it has found dangerous side effects, it is information that is important to us." "
Several major research instutions in Sweden have already promised to improve their trial reporting.
Karolinska Institute is currently uploading missing results both onto the European and American trial registries at high speed.
Till Bruckner, founder of TranspariMED, said:
"The Swedish Research Council's pledge to ensure that its grantees make their clinical trial results public is an important win-win-win for patients, taxpayers and scientists in Sweden."
"We urge the Swedish Research Council to formalise its commitment by signing up to the WHO Joint Statement as rapidly as possible, and fully implementing its provisions over the course of the following 12 months."
"TranspariMED hopes that the Swedish medicines regulator too will soon take action to protect patients and public health, as regulators in Denmark and Austria are already doing. Turning a blind eye when research institutions are breaking the rules does not constitute regulatory excellence."