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Reporting of study results: a challenge?

Since 2007 there is a legal obligation to report results of registered clinical studies in a timely manner. Now more than 10 years later, how is compliance with this regulation? Problematic, according to a recent publication in the Deutsche Ärzteblatt (Richter-Kuhlmann, E., Deutsches Ärzteblatt | Jg. 117 | Heft 31–32 | 3. August 2020, A1492-A1497). Especially academic centers lag behind when it comes to the reporting of study results. The Cochrane foundation Germany published an analysis in The Lancet, stating that out of 4.200 clinical studies in the (US-based) study register ClinicalTrials.gov [1], for only around 40% results have been communicated.

Little transparency in reporting of clinical studies.

Reporting of study results in Germany

In Germany two campaigns (TranspariMED and BUKO Pharma-Kampagne) investigated in 2019 if universities had reported results of their studies registered in EudraCT within a year, as is required since 2014. An even more dramatic picture became evident in regard to reported results of clinical trials performed at German universities: only 6.7% of the clinical trials investigating a drug had reported results. However, clinical trials sponsored by research-conducting pharmaceutical companies reported their results in 90 to 100%.
One major obstacle in reporting results from clinical trials at German universities is the delay due to processing of data. To achieve an improvement in this regard most of the universities are now providing more support for reporting to investigators.
Another hurdle are the complex legal requirements based on European regulations back in 2004 and 2006. Several databases have been established in Germany to facilitate transparency in clinical studies, e.g. PharmaNet.Bund [2] for information about drugs in the Federation and the federal states as well as the German Register of Clinical Studies [Deutsches Register Klinischer Studien (DRKS)] [3] as the only German primary register. In the first-mentioned database the health authorities should report short results after their verification to facilitate scientific research for e.g. clinical guidelines; however a study of the BIH Quest Center (Berlin Institute of Health; Quality/Ethics/ Open Science/ Translation) showed that only 61% of the study results have been reported 2 years after the termination of the clinical trial.

European reporting situation and publication in scientific journals

Nevertheless, these databases are not very well known and restricted to German language in contrast to the European Register (EudraCT) [4] where all clinical studies conducted in Europe must be registered, having a specific EudraCT-Number. Since 2014 also results should be published here, based on the EU guideline of 2012 (2012/302 03/EG), but this guideline has no binding character and its final application is depending on a working EU-Portal (not working yet, perhaps by the end of 2021?); therefore in Germany the German Drug Law is mandatory.
Hoping that publication in scientific journals might help is vain as the results have to be peer-reviewed and this procedure might take several years before final publication. Even more, often results from a clinical trial are deemed unpublishable in such journals.

What might help?

Changes that might help to find more reports of study results would be the avoidance of too many different databases, even within one country, and support the reporting of results from studies that are “negative” and / or early terminated or without new knowledge gain more efficiently.
Great Britain has made an effort to improve the reporting rate of results from clinical trials within 12 months, by e.g. cancelling funding for the respective institution in case the timeline has not been adhered to. An international joint memorandum for this target has also been signed in 2007 by the WHO and 20 big research funders, but without German participation.

So a lot of work has to be done, although also in Germany new approaches are visible. The BIH Quest Center supports Sponsors from universities regarding publication of study results, workshops are being held and a manual for universities is planned.

Topics: The Science behind Diabetes, Clinical Trials in Diabetes, Clinical Trial Methods

Posted by Dr. Grit Andersen on Apr 6, 2021 4:00:00 PM
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