Re: Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource
We thank Dr. von der Leyen for his response.
Our paper and ongoing data at EU.TrialsTracker.net examine “compliance with the EU requirement [under EU Guidelines 2012/C302/03] to post results on to EUCTR for all trials on the registry." As currently detailed on EU.TrialsTracker.net, German academic institutions currently have some of the lowest rates of compliance with 2012/C302/03 of any major sponsors (>50 trials on EUCTR). Conversely German pharmaceutical companies have some of the highest rates of compliance among major sponsors, suggesting that the barrier to compliance with EU trial reporting rules lies solely with German academics:
Boehringer Ingelheim - 103 due trials, 100% reported
Bayer - 80 due trials, 100% reported
Charité-Universitätsmedizin Berlin - 66 due trials, 1.5% reported
University of Munich (Ludwig-Maximilians) - 42 due trials, 6.2% reported
Merck KGaA - 35 due trials, 94.3% reported
Technical University of Munich - 28 due trials, 3.6% reported
Hannover Medical School - 25 due trials, 0% reported
Heidelberg University - 23 due trials, 0% reported
University of Cologne - 20 due trials, 0% reported
University Erlangen-Nuremberg - 19 due trials, 0% reported
Dr. von de Leyen points to German laws that operate in parallel to EU Guidelines. He references www.PharmNet-Bund.de as a German repository of results for clinical trials on medicinal products in Germany. We are aware of no research assessing whether German trials do indeed report their results onto this resource. Most importantly: even if compliance and quality of results was high, posting to this website does not meet the 2012/C302/03 guidelines which require results to be posted directly to the EUCTR.
The advantages of complying with EU rules are clear. It ensures that all trial results reports are in one easily discoverable and searchable location covering all trials for a territory population of more than 500 million EU citizens. By contrast PharmNet-Bund.de is comparatively obscure and contains only German trials, with the search and individual trial pages only available in German language: at minimum we respectfully suggest that this German website should simply contain an automatically generated mirror of trial reports posted to the EU register.
We are particularly concerned to read Dr. van de Leyen, speaking as Chairman of the Network of Coordinating Centers for Clinical Studies in Germany (KKS-Netzwerk e.V.), apparently indicate that the German academic community will continue to ignore the requirements of EU Guideline 2012/C302/03 in favor of posting results only to this German website, and will only comply with posting to a pan-European registry when the new 2014 laws eventually come into effect.
Trial reporting is an important practical issue for evidence-based medicine; it is also an ethical issue. Positive compliance with the EU rule sends a clear moral message, and builds trust. Patients and policymakers will reasonably wonder why German academics are stating they will ignore EU reporting requirements, while German pharmaceutical companies are readily and energetically complying. In our view, it would be better to see academics show positive leadership and set the agenda positively on this important issue. We urge Dr van de Leyen and any organisations he may represent to review their stance on this important issue.
Ben Goldacre and Nicholas J. DeVito
Competing interests: We are the authors of the piece being discussed.