Nobody in Germany is responsible for ensuring that all clinical trial results are made public. No player appears willing or able to tackle widespread research waste, according to a recent series of media reports.
The investigation by the Tagesspiegel highlights formidable barriers to tackling the non-reporting of clinical trial results that are relevant beyond Germany.
A recent TranspariMED report found that comparable legal and regulatory gaps in many European countries. Existing American disclosure legislation too fails to cover many clinical trials. So far, the UK is the only country to develop a national strategy to fix the problem for all clinical trials.
Medicines regulator: Powerless to act
Germany’s medicines regulator BfArM is unable to compel companies and institutions running clinical trials to make all results public, its head of clinical research Thomas Sudhop told Tagesspiegel.
While German law requires the results of drug trials and some medical device trials to be made public, around half of all trials conducted in the country fall outside the scope of such disclosure requirements.
The results of 30% of such trials run by German universities are not made public, wasting public funds and endangering patient safety. Companies and universities are currently under no legal obligation to make the results of these trials public.
The official indicated that BfArM is sympathetic to growing calls for action on unreported trials. However, he noted that his agency’s hands are tied because it currently lacks the required mandate and legal basis:
“In a system operating according to the rule of law, public agencies do what they are formally empowered to do, and not what they might find desirable to do.”
(TranspariMED comment: BfArM has been remarkably successful in improving transparency for drug trials, where a clear legal framework exists. Thanks to the regulator’s strong engagement and hard work by leading universities, reporting rates for drug trials have dramatically improved in Germany in recent years.)
Ministry of Health: Not our problem
The German Ministry of Health admitted that clinical trial transparency was “highly important” for patient safety and quality assurance, but stated that it was not responsible for making sure that results are made public.
A ministry spokesperson noted that most trials involving neither drugs nor medical devices – such as trials of surgical techniques – were run by universities.
Therefore, he claimed, the Ministry for Science (BMBF) and the public research funder DFG were responsible for those trials.
(TranspariMED comment: It is surprising that the German Ministry of Health regards itself as not responsible for solving a problem within German medical research that clearly harms German patients.)
Ministry for Science: Let's pass the buck
At the Ministry of Science, a spokesperson told Tagesspiegel that the ministry was committed to upholding the principle that all clinical trial results should be made public.
The ministry already encourages its own grantees to make trial results public, he said.
However, the Ministry of Science would not compel the publication of results as this would limit scientific freedom:
“Whether researchers decide to publish their results is their own responsibility.”
(TranspariMED comment: The ministry itself defines scientific freedom as “the right to freely define research questions, choose and develop theories, gather empirical material and employ sound academic research methods, to question accepted wisdom and bring forward new ideas. It entails the right to share, disseminate and publish the results…” Requiring researchers to publish the results of medical research funded with taxpayers’ money would not interfere with any of those freedoms. Public funders in many other democratic countries already require trial results to be made public. Research has found that both BMBF and DFG lack effective safeguards against research waste.
Research funder DFG: We see no problem
Germany’s second major public funder DFG claimed that it already requires the researchers it funds to make clinical trial results public within two years, and actively monitors compliance.
The establishment of “new and labour-intensive processes for which there is currently no legal basis” was therefore unnecessary.
(TranspariMED comment: In late 2022, DFG admitted to TranspariMED that it does not have a comprehensive overview of which clinical trials it had funded in past years, so it is unclear how DFG can be effectively monitoring results publication. However, DFG added at the time that it was currently evaluating its funding portfolio to generate relevant data. Note that DFG provided this information in response to a Freedom of Information request that it was not legally obliged to respond to; TranspariMED would like to thank DFG for its remarkable openness in that regard.)
Ethics committees: No enthusiasm
In theory, the problem could easily be fixed by giving the medicines regulator the legal mandate to collect a list of all trials approved by German ethics committees. The regulator would then monitor whether trial results are actually made public, as is already the case in the UK.
However, the chair of the association of German ethics committees (AKEK) was unenthusiastic about the idea.
He told Tagesspiegel that it would be wiser to work through existing structures and make trial registries more user friendly. (He did not explain how existing structures could solve the problem.) At the same time, he warned against creating “additional bureaucracy” and added that sharing data on ethics approvals with BfArM would be “a breach of trust”.
(TranspariMED comment: The proposal for BfArM to monitor reporting by using data from ethics committees would not create any additional bureaucracy for researchers. BfArM routinely manages highly confidential information, and ethics committees would only have to share the name of the trial sponsor and the title of the trial with the regulator. Registries are the only way to ensure that all trial results are made public. TranspariMED strongly supports calls to make trial registries more user friendly. BfArM is currently improving the German DRKS registry. Hopefully, in future it will be easy to report results on DRKS.)
Need for political action
Till Bruckner, founder of TranspariMED, said:
“Around half of all clinical trials run in Germany fall outside existing transparency legislation. Of those, nearly a third never make their results public. German patients are being harmed as a result.”
“Evidently, no government agency sees itself as responsible for protecting patients’ and taxpayers’ interests.”
“Experience from the UK clearly shows that this problem can be solved at minimum cost. Germany’s political leadership must take action to protect patients from further harm.”