A study looking at 499 small clinical trials run by German universities found that 142 trials (28.5%) have never made their results public - neither in a peer-reviewed journal, nor in a trial registry, nor as a dissertation.
Trials that did publish their results took a median of over three years to do so.
(Remember that many pivotal Covid trials made their results public within just a few weeks, or a few months at the most.)
Image taken from: Jansen et al 2022
Public money wasted
In Germany, clinical trials run by universities are typically funded with public money.
A 2021 assessment found large gaps in the research waste safeguards of Germany’s two leading medical research funders. Of 11 safeguards recommended by the World Health Organisation, BMBF had only put only 5 into place, and DfG had only adopted 4.
What does German law say?
Reflecting European regulations, German law since early 2022 requires clinical trials involving investigative drugs or certain medical devices to make their results public within a year.
However, German regulatory agencies BfArM and Paul-Ehrlich-Institut recently informed TranspariMED that there is no legal requirement to make the results of other types of trials public.
As a result, many clinical trials – such as trials of surgical techniques or physiotherapy – occupy a de facto legal vacuum, leaving federal regulators unable to take action.
German policy makers must act
Till Bruckner, founder of TranspariMED, said:
“German policy makers must take action to curb costly and avoidable research waste.”
“German patients must be able to trust that if they participate in a clinical trial, those results will rapidly be made public. Equally, German taxpayers should be able to trust that publicly funded medical research actually benefits the public.”
“In recent years, German regulators and universities have made fantastic progress on improving and speeding up drug trial reporting, showing that where there is a will, there is a way.”
“Germany needs to set up a watertight national system to ensure that all clinical trial results are rapidly made public, as the UK has already done. That is far cheaper than continuing to waste money on invisible science.”
According to Declaration of Helsinki global ethics rules, the results of all clinical trials must be made public; failure to do so is a breach of medical research ethics.
In addition, the World Health Organisation stipulates that all trial results should be made public on a trial registry within one year, and in a journal within two years of trial completion. Even the less demanding two-year benchmark was hit by only 28% of German trials assessed according to the study discussed above.
The study discussed in this blog can be accessed here.
A policy brief explaining how the new UK system works can be downloaded below:
Note on methodology:
The finding that close to a third of German academic clinical trials end up as costly research waste is in line with previous research. The authors of the latest paper re-used the publicly available IntoValue dataset of German academic clinical trials, limiting their cohort to Phase II-III, III and IV trials with 150 or fewer participants. As per registry data, 64 trials in their cohort had been terminated early.
The authors were able to follow up trials for a median of over 9 years, with an absolute minimum follow-up length of 47 months. They used the IntoValue trial registry and literature search strategy (strong methodology) during August-November 2021. They also tried to contact PIs of unreported trials, but only 13% responded.
TranspariMED is currently running a separate research project also drawing on the same IntoValue dataset.
Stay tuned to this blog for updates.