German patient groups call for clinical trial transparency law

The debate about missing clinical trial results in Germany has taken a fresh turn, with two powerful patient groups demanding the mandatory disclosure of all clinical trial results. Germany’s political parties appear to be divided on whether to introduce new legal requirements.

The issue hit the political radar in Germany after a study revealed that the results of nearly a third of 1,700 clinical trials run by universities in the country have never been made public, wasting public money and leaving potentially dangerous gaps in the medical evidence base. A coalition led by Cochrane Germany has recently begun advocating for Germany to fix the problem.

At present, German law only requires the results of drug and medical device trials to be made public. Around half of all clinical trials in Germany fall outside the scope of existing disclosure laws.

Patient groups call for transparency law

Deutsche Stiftung Patientenschutz, a national patient support and advocacy group, has called on the German government to ensure that all clinical trials are registered and their results made public.

Eugen Byrsch, head of the group, told a reporter from the Tagesspiegel that failures to make clinical trial results public led to the unnecessary repetition of studies.

Beyond wasting money, he explained, this duplication and triplication of studies also placed a burden on patients who volunteered to participate in trials. He called on the minister of health and the minister for research to introduce a legal requirement to publish all trial results.

Martin Danner, the head of BAG Selbsthilfe, an umbrella group representing German disability and chronic disease support groups, echoed this demand.

“We want publication [of clinical trial results] to be made mandatory,” he said, adding that the non-publication of results was “unacceptable,” particularly from the perspective of patients who volunteer to participate in studies.

Danner explained that BAG Selbsthilfe already connects researchers to relevant patient groups only if they promise to make study results public. He suggested that a safeguard mechanism to ensure that studies involving patients are methodologically sound and have patient-relevant endpoints would also add value.

[Note: In May, Marburger Bund, a German association representing 135,000 doctors, called for sanctions for non-publication of clinical trial results.]

Mixed reactions from political parties

Three German political parties explained their current position to the reporter:

• A spokesperson for FDP, which forms part of Germany’s ruling coalition, said that his party was aware of the problem and supported the rapid publication of trial results on registries on a voluntary basis. However, he cautioned against new legislation and sanctions, citing concerns about generating additional paperwork for researchers. [Note: Germany could fix its research waste problem without burdening scientists with additional bureaucracy.]

• A spokesperson for the largest opposition party, CDU, also favoured voluntary approaches over legal mandates.

• Die Linke, another opposition party, supports mandatory publication of results, at a minimum for trials funded with taxpayers’ money. “Public funding must generate public returns,” a spokesperson said. She suggested increasing the budgets for university trials to ensure that the costs of publication are fully covered. [Note: The WHO has also called for public funders to cover publication costs.]

Most German politicians are currently away on their summer breaks. Tagesspiegel was unable to obtain a statement from the two largest parties in the governing coalition, SPD and Greens, or from the AfD opposition party.

The content of this blog is based on reporting published by Tagesspiegel in German language. Previous reporting by the same newspaper found that no government ministry is willing to accept responsibility for tackling the problem.