The ethical principles for medical research involving human subjects are laid down in the Declaration of Helsinki of the World Medical Association. The Declaration also defines the measures for maintaining transparency about the content of clinical trials, whether ongoing or completed. The Coordination Centre for Clinical Trials (KKS) has compiled an overview of the registration and publication requirements for this purpose.
According to Article 35 of the Declaration of Helsinki, every research project involving subjects must register in a publicly accessible database before the first subject is recruited.
Therefore, it is a requirement of the International Committee of Medical Journal Editors (ICMJE) that only studies that have been registered in a recognised registry before the start of patient recruitment should be published.
The World Health Organization (WHO) has set up a portal listing registries recognised for this purpose.
The most common trial registries are ClinicalTrials.gov at the National Institute of Health in the USA and the German Clinical Trials Register (DRKS), now located at the Federal Institute for Drugs and Medical Devices (BfArM).
Researchers are also obliged under the Declaration of Helsinki to make the results of their research on humans publicly available (Article 36).
Negative and inconclusive results must be published in the same way as positive ones.
If results of clinical trials are published late or not at all, this can distort the basis of such an evaluation (publication bias).
Late publication or complete omission of study results is considered unethical. This is because study participants can expect that the results of the study in which they participated will be published.
According to the EU Regulation on Clinical Trials of Medicinal Products, the sponsor of a clinical trial must submit a summary of the results of the clinical trial to the Clinical Trials Information System EU database (CTIS) within one year of its end, regardless of the outcome of the clinical trial. This is independent of the publication in a scientific journal.
For trials started under the old German Medicines Act (AMG), the results must be submitted to the competent higher federal authority via the CESP portal; for authorised active substances, they must also be submitted via the PharmNet.Bund portal. The ethics committees involved also receive the results report of the clinical trial from its sponsor.
For the older AMG studies, there is also an obligation to publish the results in the EU Clinical Trials Register (EU-CTR).
In the case of clinical trials with medical devices, the sponsor also submits the final report to the competent higher federal authority within twelve months after discontinuation or completion of the clinical trial. Receipt of the report is confirmed by the BfArM. The final report, as well as the application, is submitted via the German Medical Devices Information and Database System (DMIDS) of the BfArM.
Organisations committed to transparency in clinical trials:
- The Oxford University initiative "Trialstracker" uses its website to publish the publication rate of sponsors' trial results in the EU register.
- The TranspariMED campaign regularly asks sponsors, especially universities and hospitals, about unpublished trial results in order to further increase publication rates. TranspariMED reports on the results.