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In a startling revelation, 30% of clinical studies conducted by German university hospitals remain unpublished. This significant nonpublication rate distorts the evidence base, potentially leading to poorer patient care, according to Jörg Meerpohl, MD, director of the Institute for Evidence in Medicine at the University Medical Center Freiburg, and director of Cochrane Germany.
Speaking at a Science Media Centers press briefing, Meerpohl emphasized the need for legal mandates requiring the publication of all clinical studies. The Alliance for Transparency in Health Research has highlighted the absence of such requirements for “nondrug, nonmedical device” studies, encompassing areas like surgery, dentistry, psychotherapy, and physiotherapy.
Transparency Gaps and Consequences
While EU regulations mandate the registration and publication of clinical drug trials and certain medical devices, such as stents or pacemakers, similar rules are missing for nondrug studies. The lack of published results not only undermines clinical decision-making but also erodes the trust of study participants and squanders research funding.
Stefan Sauerland, MD, head of the Nondrug Procedures Department at the Institute for Quality and Efficiency in Health Care (IQWiG), warned that incomplete data could lead to incorrect clinical decisions or delay the implementation of effective treatments. This issue impacts professional societies as they develop clinical guidelines, potentially affecting patient outcomes.
Calls for Comprehensive Registration and Publication
The Alliance for Transparency in Health Research calls for complete registration and publication of all studies. They propose a centralized registration system with regular updates and obligatory result publications. Incentives for maintaining register entries and penalties for nonpublication are also recommended.
Christine Fuhrmann, PhD, deputy chair of the KKS Network and head of the Study Center Bonn, criticized the current European medical device register, EUDAMED, for its inefficiencies. She advocates for statutory regulations to ensure transparency but cautions against excessive constraints that might hinder research.
Practical Challenges and Solutions
Georg Schmidt, MD, head of the Biosignal Processing Research Group at the Technical University of Munich, highlighted the time-consuming nature of registering studies, exacerbated by inadequate digitization. The Ethics Committee Working Group (AKEK) plans to introduce digital tools to simplify the registration process.
Meerpohl pointed out that “lack of time” is the most common reason researchers do not report study results. Studies with less favorable outcomes are often neglected in favor of new projects, leading to a bias in published data.
Sauerland provided examples where missing data delayed treatment evaluations or hid adverse effects. He stressed the necessity of registering all studies approved by ethics committees and establishing a central repository to track their outcomes.
Learning from Other Systems
The UK model, where study proposals reviewed by ethics committees are reported to a central authority, offers a potential blueprint. This system ensures standardized registration and central monitoring, allowing for timely inquiries and sanctions if studies remain incomplete.
Moving Forward
Fuhrmann suggested enhancing the German Clinical Trials Register (DRKS) by improving digital interfaces and expanding its capabilities. The transfer of DRKS to the Federal Institute for Drugs and Medical Devices (BfArM) has limited its functionality due to resource constraints. Empowering the DRKS could simplify the incorporation of studies across various fields, promoting transparency and improving patient care.
In conclusion, the nonpublication of clinical studies at German university hospitals underscores the urgent need for legal requirements and improved infrastructure to ensure complete and timely dissemination of research findings.
