German research ministry: We will monitor clinical trial publication

The German research ministry, a major funder of medical research in the country, is planning to monitor whether its grantees make their clinical trial results public.

In addition, the ministry is internally discussing possible sanctions for researchers who make trial results public late or not at all.

The plans only apply to clinical trials directly funded by the ministry itself, the Bundesministerium für Bildung und Forschung (BMBF).

What exactly are the rules?

In July, a spokesperson of the ministry had told a journalist that ‘scientific freedom’ meant that it was up to researchers themselves to decide whether or not to publish the results of their clinical trials, even if those trials had been funded with public money. The statement appeared to contradict the ministry’s own clinical trial transparency policies.

TranspariMED immediately filed a Freedom of Information request to clarify the ministry’s position.

Rapid publication of results is mandatory

In its response, the ministry appeared to walk back on its earlier statement:

• BMBF stated that it is committed to the ethical and scientific standards set out in the Declaration of Helsinki, which requires all trial results to be made public.

• Researchers running trials funded by BMBF are obliged to upload their results onto a trial registry within 12 months of study completion, a key mechanism to ensure that new scientific insights are rapidly shared. In addition, researchers have to publish the results in a scientific journal within 24 months of study completion. Compliance with these policies is mandatory [“bindende Pflicht”].

• BMBF plans to “monitor and document” whether researchers meet publication requirements. However, the rules only apply to trials approved since 2019, and all those studies are still ongoing. Therefore, monitoring compliance will only become relevant from July 2024 onwards.

• BMBF is “currently reviewing” which sanctioning measures would be “appropriate and applicable” in case researchers do not make trial results public within the set timeframes.

Doctors and patients drive transparency

A large doctor’s association and two powerful patient groups recently called on the German government to ensure that all clinical trial results are made public.

At present, the results of nearly a third of non-drug trials run by German universities are never reported and end up as costly research waste. Many other results are only made public after a delay of several years.

Following a similar public outcry over missing drug trial results several years ago, major German universities dramatically improved the reporting of drug trial results. Recently, the largest medical university in the country finished the process of clearing its entire backlog of unreported drug trials, achieving a perfect 100% reporting rate.

Legal vacuum for non-drug trials

Making the results of drug trials public recently became a legal requirement in Germany. However, around half of all trials run in the country still fall outside the scope of existing disclosure laws, and no government body is responsible for ensuring that their results are made public.

Only a small minority of the many trials operating in this legal vacuum are funded by the research ministry BMBF, and therefore the ministry’s planned monitoring efforts will have limited immediate impact. (The other major German public research funder, DFG, has also initiated efforts to reduce research waste within its own portfolio.)

However, the ministry’s commitment to curbing research waste within its own portfolio may have wider implications because the ministry’s mandate also includes overseeing the work of universities in general.

Opportunity to end all research waste

A coalition of medical groups led by Cochrane Germany recently developed a blueprint for a national system that would ensure that all clinical trial results are rapidly made public, without burdening German researchers with additional paperwork.

Till Bruckner, founder of TranspariMED, said:

“TranspariMED strongly welcomes BMBF’s commitment to improving transparency in medical research. Monitoring whether BMBF grantees follow the rules will not only reduce research waste, but will also considerably accelerate the speed at which new scientific insights can be translated into better patient care.”

“This sends a hopeful signal to German patients, doctors and taxpayers that policy makers are finally taking their concerns about costly medical research waste seriously.”

“Hopefully, political decision-makers will now ensure that the same transparency rules are evenly applied to all clinical trials involving German patients.”