Universities in Germany are set to face awkward questions over their medical research ethics and use of public resources after researchers have discovered that a large number of clinical trials sponsored by 36 academic institutions in the country have never reported their results.
Failure to report clinical trial outcomes is unethical and sometimes illegal. Non-reporting harms patients, most notoriously in the case of lorcainide, when American doctors inadvertently killed over 100,000 people because the results of a single academic clinical trial remained hidden.
It also betrays the trust of clinical trial participants, who volunteer in the hope of making a contribution to medical progress.
German taxpayers are unlikely to be amused. Unreported university trials contribute nothing to science, and thus are a waste of public money.
This type of research waste is easy to avoid: While a clinical trial typically costs millions to run, the cost of posting results onto a public registry is only $2,000 per trial.
The results of the trials identified by the German research team are literally invisible, as they have neither posted their summary results on trial registries, nor published them in academic journals or in any other form.
Unless the universities involved act rapidly to secure and publish this data, medical knowledge that cost hundreds of millions of Euros to generate may be lost forever.
“We’ve had some interest from the German government,” Dr Nico Riedel, one of the researchers conducting the study, told TranspariMED. Worldwide, medical research worth $85 billion is wasted every year due to non-reporting of results.
The team did not assess how many of the unreported trials are in breach of EU transparency regulations or US disclosure laws. Posting the summary results of some types of trials has long been a requirement on both sides of the Atlantic, but these rules remain unenforced.
For example, the German national regulator (the Bundesinstitut für Arzneimittel und Medizinprodukte) could nationally enforce summary results disclosure on the European trial registry, but does not seem to have taken any action to date.
In 2017, Transparency International, Cochrane, CRIT and TranspariMED jointly called on governments worldwide to finally enforce existing transparency provisions.
Dr Riedel explained that while awareness of the problem among German universities was still low, there are indications that some are finally waking up to the issue. If they fail to do so, they may soon find themselves unable to access grant money from major research funders, many of whom have recently pledged to crack down on research waste in their portfolios.
In the United States, many universities – but by far not all – have already invested considerable effort into ensuring that the summary results of trials are posted onto the American trial registry. Faced with mounting public and political pressure, a few UK universities have also begun addressing the problem, but implementation is proceeding at a slow pace.
The Declaration of Helsinki, which sets out the ethical rules for research in human subjects, explicitly states that:
“Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. (…) Negative and inconclusive as well as positive results must be published or otherwise made publicly available.”
The study of German university trials was conducted by the IntoValue#1 project, which headed by Dr Daniel Strech. It is housed by the Berlin Institute of Health’s QUEST Center and led by the Hannover Medical School in cooperation with the University Clinic Freiburg (Cochrane Deutschland). It seeks to determine the proportion of clinical trials without published results for each of the 36 German medical faculties, covering all trials completed between 2009 and 2013.
To exclude the possibility that a publication had accidentally been overlooked, the team followed a multistep search protocol. The total number of unreported trials identified in this manner is likely to err on the conservative side because the team only included trials formally marked as ‘completed’ on registries.
The IntoValue#1 research team has already completed the process of data collection and analysis. TranspariMED will cover the results in detail as soon as the study is published.
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Note: To learn more about why reporting clinical trial results is so important, and the relevant ethical, legal and regulatory frameworks, see this study.