In a bizarre move, the German government has assured the opposition that it intends to take action on unreported clinical trials - by pointing to a draft law that has nothing to do with clinical trials.
The largest opposition faction in national parliament, CDU/CSU, recently submitted detailed questions to the government asking how it plans to fix the problem.
In its response, the government argued that the problem was already solved for drug and medical device trials, and that a draft law on the use of existing health data would ensure that the results of all other trials are also made public.
Both claims are false.
False claim 1: Problem solved for drug & device trials
The government stated that the problem was already solved for drug and medical device trials:
“For clinical studies with medicinal products under the Medicinal Products Act, as well as for clinical trials with medical devices and clinical performance studies with in-vitro diagnostics, the requirement for data transparency is met.”
In reality, many such trials currently still do not make their results public, despite significant improvements led by major German universities in recent years.
Drug trials. The first drug trials covered by new disclosure requirements are due to make their results public on the European CTIS trial registry in early 2024. The key test will be what happens when the first German company or institution fails to publish results as required by law. Will German medicines regulator BfArM chase up the missing result? Will BfArM impose fines? We will only find out next year.
Medical device trials. No medical device trials covered by new transparency laws have become due to report results on the European EUDAMED database yet. German device companies are unlikely to immediately achieve full compliance because they have never before had to deal with similar transparency requirements. Again, whether and how BfArM responds to the first violations will be key.
BfArM has made considerable and successful efforts to improve the reporting of drug trials in recent years, so there is cause for optimism that BfArM will actively engage in coming years. However:
It is false to claim that the problem has already been solved for drug or device trials.
False claim 2: Problem will be solved for 'other' trials
Currently, German law only requires the results of drug and medical device trials to be made public.
Companies and universities are still not legally required to make public the results of other trials, including clinical trials of surgical techniques and physiotherapy. Doctors’ and patients’ groups in Germany have recently called for the government to adopt new legal safeguards.
The government argued that:
“The draft GDNG [Gesundheitsdatennutzungsgesetz / Law on Use of Health Data] stipulates that the results of research projects that are legitimately processed for research purposes on the basis of statutory processing provisions without the consent of data subjects pursuant to this Act must be published within 24 months of the completion of the research project…“
“In addition, the draft stipulates that a research project must always be registered. The pre-registration of scientific research projects is a recognised quality assurance measure. In the past, it often referred only to clinical studies; in the GDNG, this is also introduced for non-interventional studies.”
In fact, the draft law covers the use of observational public health data. It has absolutely nothing to do with interventional clinical trials, and will do nothing to improve the registration and reporting of 'other' trials in Germany.
True claim: lack of oversight
The government admitted that it currently has no overview over whether clinical trial results are actually made public:
“A detailed analysis of the frequency and temporal distribution of non-publication of results of clinical trials conducted with German academic institutions as sponsors is not available to the Federal Government.”
Going forward, BfArM will have a comprehensive overview of all drug and medical device trials in Germany thanks to the CTIS registry and EUDAMED database.
The new law on health data will not generate an overview of all 'other' trials, which account for between a third and half of all trials run in Germany. It will thus remain impossible to systematically check whether these trials report results.
Empty lip service
The German government affirmed its commitment clinical trial transparency - in theory:
“The Federal Government attaches great importance to the transparency of clinical trials… Transparent and comprehensive information on all studies conducted is essential for an informed decision on the safety and efficacy of new therapies. A high degree of transparency about the studies carried out and their results is therefore of great importance.”
“The Federal Government is clearly committed to the ethical and scientific standards of Good Clinical Practice for the planning, conduct, documentation and reporting of clinical studies on humans, which are laid down in the Declaration of the World Medical Association of Helsinki, and thus also to the principle of transparency. Compliance with the Declaration is also anchored in the professional code of conduct for physicians.”
However, nothing in its response suggests that the government will act on this commitment.
An effective alternative approach
Fixing this problem is possible - at minimal cost.
A coalition of German health groups including TranspariMED recently proposed an effective alternative approach.
Under this alternative approach, German medical ethics committees – which have to approve every clinical trial run in the country – would send their approval information to the medicines regulator BfArM, which would then directly register the clinical trial on behalf of the institution running it. Subsequently, BfArM would use registry data to monitor whether results were made public, and follow up in case of non-compliance. A similar model is already being set up in the UK.
This alternative approach would have several advantages: It would be cheap, easy to implement, use existing structures, and not create any additional red tape for medical researchers. Best of all, it would be watertight, capturing every single trial run in Germany. It could probably be adopted without new legislation.
The CDU/CSU enquiry explicitly flagged this alternative approach and asked the government to take position on it. The government declined to comment on this point.
Till Bruckner, founder of TranspariMED, said:
"There is now a clear consensus that unreported clinical trials are a significant problem in Germany. This problem can easily be fixed at minimal cost, but that will require decision makers to adopt solutions that actually work. German lawmakers and patients deserve honest answers and real solutions."
Note: Cochrane Austria has published a German language guide to clinical trial transparency: