Loading ...

The results of 30% of all clinical studies led by German university hospitals remain unpublished. "This leads to a distortion of the evidence base and can ultimately result in poorer patient care," said Jörg Meerpohl, MD, director of the Institute for Evidence in Medicine at the University Medical Center Freiburg, Freiburg, Germany, and director of Cochrane Germany, at a press briefing by the Science Media Centers. With its position paper, the Alliance for Transparency in Health Research is now drawing attention to the lack of legal requirements for the publication of clinical studies in all medical areas.

While the European Union (EU) has established the legal basis for the registration and publication of summaries of study results in clinical drug trials (EU Regulation 536/2014), the rules also apply to certain medical devices such as stents or pacemakers (EU Regulation 745/2017). While there is now much more transparency in the field of commercial clinical drug studies and medical devices, such rules are missing for so-called "nondrug, nonmedical device" studies, such as in surgery, dentistry, psychotherapy, or physiotherapy.

Missing Results, Wrong Decisions

The nonpublication of results means not only that clinical mistakes might be made but also that the trust of voluntary study participants who invest time and effort and accept risks in participating in a study could be undermined, said Meerpohl, who is a co-author of the position paper. In addition, research funds for studies that are not registered or published would in the end be wasted.

Missing results could mean, in the worst case, that wrong decisions are made or that new treatment methods do not reach the patient, said Stefan Sauerland, MD, head of the Nondrug Procedures Department, Institute for Quality and Efficiency in Health Care (IQWiG) in Cologne, Germany, and co-author of the position paper. The issue of incomplete data affects not only the IQWiG "but also professional societies when they create their guidelines," said Sauerland.

Studies involving medical devices need improved transparency, according to Christine Fuhrmann, PhD, deputy chair of the KKS Network (Coordinating Center for Clinical Studies) and head of the Study Center Bonn at the University Hospital Bonn, Bonn, Germany. "In the case of medical devices, we have a dysfunctional European register, the EUDAMED register. As researchers, we cannot yet publish our results from studies involving medical devices there," said Fuhrmann.

Registration and Publication

The Alliance for Transparency in Health Research demands the creation of conditions for complete study registration and publication of results in Germany. All studies should be centrally registered from their inception, and study authors should regularly be reminded to update their study register entries and obliged to publish their results, said the Alliance. Incentives should promote the active maintenance of register entries and sanction long-term nonpublication.

Fuhrmann emphasized that the KKS Network fully supports the demand for more transparency. From the network's perspective, however, a statutory regulation would not encourage research in Germany because it would increasingly impose "constraints" on researchers, which is why the network did not sign the position paper.

Regarding the necessity of registering studies before starting and publishing later, Georg Schmidt, MD, head of the Biosignal Processing Research Group at the Clinic and Polyclinic for Internal Medicine at the Technical University of Munich, Munich, Germany, and chair of the Ethics Committee Working Group (AKEK), emphasized that even registration is not easy. "If you want to register a study in a World Health Organization register, you will spend 8-10 hours getting everything together. That takes time."

Schmidt sees inadequate digitization as one of the main problems. To facilitate registration for researchers, the AKEK now plans to simplify the process using digital tools, so that registration could occur almost automatically when the study protocol is created.

Lack of Time

According to Meerpohl, researchers conducting studies most commonly cite "lack of time" as the reason for not reporting study results. In addition, research sometimes happens in the investigators' spare time. "Especially when study results are not particularly attractive or when the study does not go as planned, researchers often prefer to focus on the next research proposal," said Meerpohl. "This means that studies that may not have produced positive results, but which would be important as a corrective, are either published late or not at all."

Sauerland emphasized that problems arise when data are missing. He recalled a case in which the IQWiG was tasked with evaluating a specific form of radiation for brain metastases. A study that should have been completed 10 years earlier was found, yet nobody could provide results. "This delayed the decision in favor of this treatment method," said Sauerland.

In another case, the published data showed the benefit of a medication, but the unpublished data indicated that the medication caused harm. "We are not asking for much," said Sauerland. "We actually just need registration of all studies that have been approved by ethics committees. In addition, we need a central nationwide repository of these studies so that what becomes of them can be tracked."

What's the Solution?

In the United Kingdom, study proposals that are reviewed by ethics committees must be reported to the Health Research Authority. This authority centrally compiles data, initially registers studies, and then hands this information over to clinical researchers. "This [system] ensures that all studies are registered in a standardized way," explained Meerpohl. Central monitoring can enable inquiries into whether, for example, a study has not been completed and provide for sanctions in such cases.

Inadequate information technology solutions in Germany and the EU burden clinical researchers significantly, said Schmidt. "We can create electronic tools that are quick and easy to use. We need to make registration easier for researchers," he said.

This approach is good, but there is still a long way to go, said Fuhrmann. She suggested strengthening and expanding existing tools, such as the German Clinical Trials Register (DRKS). Because its transfer to the Federal Institute for Drugs and Medical Devices (BfArM), the DRKS, which was previously located in Freiburg, Germany, no longer has digital interfaces that would allow data from the register to be transported to other local levels, said Fuhrmann.

When she asked the BfArM whether the DRKS could be expanded, she received the response that it is currently not possible because of resource constraints. "That's why my call is to empower this register and set up interfaces so that it is possible to incorporate studies from different areas," she said. Enhancing existing resources could result in significant simplification, she added.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.