German doctors' association calls for sanctions if clinical trial results are not made public
An association representing 135,000 German doctors today called for government bodies to require all clinical trial results to be rapidly made public, and to sanction those who break the rules.
Financial penalties for violations should no longer be a "taboo," the Marburger Bund demanded.
According to a press release:
Regardless of the result, the results of clinical studies must be freely accessible in full in accredited databases at European and German level and published in a timely manner. This is what the 141st General Assembly of the Marburg Association in Essen called for today.
Even if a study was discontinued, the reasons for this would have to be published. Every finding from clinical studies could result in changed treatment concepts and call into question previous certainties. Scientific studies aim to improve the quality and safety of patient care.
"Since most of the research is publicly funded, the responsible state institutions should ensure that the publication requirement is actually observed. In the event of violations, financial sanctions should no longer be taboo," says the resolution.
Only recently, the new head of Germany's health technology assessment body IQWIG told the media that there should be "very strong" ['knallharte'] sanctions on those that fail to make clinical trial results public.
Many German trials remain invisible
Research has shown that nearly a third of clinical trials run by German universities never make their results public. (The study focused on non-drug trials, but also included some drug trials.) Comparable data for trials run by German pharmaceutical and medical device companies are not available.
Hidden clinical trial results endanger patients' health because they prevent doctors from reliably determining how safe or effective a treatment really is.
Germany recently put into place a legal requirement to make the results of drug trials public on the European trial registry within one year of trial completion, but drug trials account for only half of all clinical trials in the country.
There is still no legal requirement to publish the results of non-drug trials involving German patients.
Waste of public money
Even oversight over German trials that are funded with public money is currently weak in Germany.
A recent study supported by TranspariMED found that the country's two largest funders, DFG and BMBF, fell far short of World Health Organisation standards for preventing research waste. Experience from the United States shows that strong funder policies and safeguards can considerably improve and accelerate clinical trial reporting.
Till Bruckner, founder of TranspariMED, said:
"When 135,000 doctors warn that medical evidence gaps are a serious healthcare problem, the German government urgently needs to wake up. People volunteer to participate in clinical trials because they want to help scientists to develop better drugs and medical devices, but their trust is betrayed if results are not made public."
"Fixing this problem is far cheaper than continuing to waste money on invisible studies that benefit nobody. Germany should follow the UK's example and set up a national monitoring system to track all clinical trials and ensure that their results are rapidly made public."
Marburger Bund's press release can be found here. Note that while an assessment in late 2022 found that the policies and safeguards of DFG were weak (see above), the funder is currently conducting an audit of its trial portfolio, which indicates that DFG is aware of the problem and may be working to fix it.