Studies with patients are the basis for medical progress. There is broad agreement on this in clinical practice and research. However, such studies are only valuable if a few important requirements are met: They must be well designed so that their results are meaningful. They must be reviewed by an ethics committee in advance in order to avert possible harm to test subjects. And their results must be published after the end of the study, no matter how the studies end, so that everyone can benefit from the new knowledge.
To ensure all this, drug authorities worldwide have been working on more transparency for several years. Valid in the EU since January 31 of this year a new regulation on human trials of medicinal products – and a central point is the mandatory entry of all studies and results in an electronic portal called CTIS. The “Clinical Trials Information System” is intended to achieve three things at once: drug authorities, applicants and ethics committees can work on the documents here without much bureaucracy, everything is on one platform, a single application is sufficient for the entire EU – and the public also receives it timely insight into the plans and results. From January 31, 2023, all applications for clinical trials must go through CTIS, as required by law. Permissions can only be granted here.
After ten months, there are no fewer, but even more defects
The problem: the platform doesn’t seem to be able to do that at the moment. The system does not work properly, which means that the careful examination of research applications by ethics committees is prevented, the working group of medical ethics committees in the Federal Republic of Germany (AKEK) complains in a unanimously approved fire letter that the German Medical Association (BÄK), the German university medicine , industry associations and the Association of University Hospitals all signed. Even after ten months of practice, the portal suffers from serious shortcomings that have not been eliminated in the past few months, but have actually increased, the letter says. This means that the application for clinical trials and their processing by the ethics committees are “massively impaired and cannot be managed”.
According to Georg Schmidt, chairman of the ethics committee of the Technical University of Munich and AKEK, only 110 of the approximately 1,000 German ethics applications that are made each year are made via the portal. “It’s hard to imagine what would happen if all applications were to go through the portal, then catastrophe would follow.”
The portal is already crashing regularly, says Schmidt. Sometimes documents could not be uploaded at all. And the up to 500 papers that have to be attached to an application can only be divided into two subfolders in the system, so that an overview is hardly possible. Some commissions from other EU countries have already rejected applications on the portal, almost as an “emergency brake,” says Schmidt, because they were not able to demand changes to protect the test subjects. “And before an application simply goes through, which cannot be adequately checked due to the deficiencies of the platform, it has to be rejected.” It is an absurd situation that also entails disadvantages and risks for patients.
BÄK President Klaus Reinhardt also agrees: The BÄK has made great efforts over many years to contribute to the smoothest possible start to use of the study portal. “However, the current technical problems with CTIS have the potential to significantly damage Europe as a research location.” The signatories to the fire letter fear that the obligatory processing of applications via a portal “with massive functional problems” will endanger drug research in Europe. If pharmaceutical companies and universities migrated abroad with their studies, this would have negative consequences for patients in Germany and the EU having early access to new therapies.
The EMA promises to solve the problems
Karl Broich, President of the Federal Institute for Drugs and Medical Devices (BfArM), agrees that clinical studies in Europe are important for the people living here. “Study results from Asia, for example, cannot always be transferred to Europe without further ado,” he emphasized only recently in a blog post by the BfArM on the reorganization of clinical research in Germany. “It must therefore be in all of our interests to strengthen the EU as a place to study.”
However, Broich sees a way to strengthen this location in CTIS – precisely because of the planned quick access for all actors. The BfArM President hopes for a reduction in bureaucracy and a boost for more transparency because results are accessible more quickly. However, the BfArM does not want to answer whether the system is really running so badly and by when a revision can be expected. It refers to the responsibility of the European Medicines Agency EMA. The Federal Ministry of Health, on the other hand, confirms that “technical challenges still arise when using the new system”. The European Commission and the EMA are working to ensure that solutions are found as quickly as possible. When asked, the EMA emphasizes that it recognizes “that some users have problems with the system”. Intensive work is being done to ensure that the system is running securely at the time of mandatory use. To this end, investments have also been made in new resources.
The signers of the letter of protest certainly recognize the opportunities associated with the CTIS portal: the BÄK has supported the conversion to the portal for many years, says Klaus Reinhardt, and many hopes are associated with the Europe-wide coordinated procedure. AKEK chairman Schmidt also emphasizes that digitization makes sense in principle. The signatories to the letter therefore demand that applications can still be submitted and processed outside of CTIS beyond January 31, 2023 – and without a new deadline being announced straight away, emphasizes Schmidt: “This should be guaranteed until the functionality of the EU portal is actually established.”