Re: Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource
To the Editor,
Recently, poor compliance with the European Commission requirements for trial results to be reported to the EU Clinical Trial Register (EUCTR) was reported by Goldacre et al. (BMJ 2018;362:k3218 | doi: 10.1136/bmj.k3218). For non-commercial, mostly academic institutions, lower reporting rates for clinical trial results were reported in comparison to commercial sponsors.
We strongly contradict that German academic institutions are not publishing clinical trial results of registered clinical trials.
In Germany, the submission of the summary of the results of a clinical trial with medicinal products for publication in a publicly available database (www.PharmNet-Bund.de) was made mandatory on January 1, 2011. The legal basis is to be found in § 42b of the German Drug Law (Arzneimittelgesetz - AMG). The legal requirement in Germany encompasses the same kind of clinical trials as mentioned in the scope of the Commission Guideline 2012/C302/03. The requirement also includes retrospective publication of a summary of trial results of clinical trials conducted as of August 6, 2004 (the date the 12th update of the AMG, which included Directive 2001/20/EC, came into force). The summary of results can be submitted in German or in English; data provision is in standard format (ICH E3, synopsis of trial results or publication).
PharmNet.Bund is a cooperative project of the German regulatory authorities – Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)) and Paul-Ehrlich-Institut (PEI) - and other federal offices or institutions. Clinical trial results are uploaded to the database of the portal PharmNet.bund by the sponsor, reviewed by the applicable German competent authority (BfArM, PEI), and then made publicly accessible by the competent authorities in the above mentioned portal.
The KKS-Network as representative of a network of German academic sponsors of clinical trials agrees to the need for transparency and therefore generally supports a requirement to publish summaries of results of clinical trials. This indeed has been realized according to the above mentioned legal requirements in Germany. After discussion with the German competent authority our academic member institutions will continue to report clinical trial results in accordance with German legal requirements to the portal PharmNet.bund. When the EU regulation 536/2014 will get into effect, German academic sponsors will submit clinical trial results to the EU electronic portal as foreseen in regulation 536/14.
Best regards,
Prof. Dr. med. Heiko von der Leyen
Competing interests:
No competing interests
14 January 2019
Heiko von der Leyen
Chairman of the Network of Coordinating Centers for Clinical Studies (KKS-Netzwerk e.V.)
Rapid Response:
Re: Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource
To the Editor,
Recently, poor compliance with the European Commission requirements for trial results to be reported to the EU Clinical Trial Register (EUCTR) was reported by Goldacre et al. (BMJ 2018;362:k3218 | doi: 10.1136/bmj.k3218). For non-commercial, mostly academic institutions, lower reporting rates for clinical trial results were reported in comparison to commercial sponsors.
We strongly contradict that German academic institutions are not publishing clinical trial results of registered clinical trials.
In Germany, the submission of the summary of the results of a clinical trial with medicinal products for publication in a publicly available database (www.PharmNet-Bund.de) was made mandatory on January 1, 2011. The legal basis is to be found in § 42b of the German Drug Law (Arzneimittelgesetz - AMG). The legal requirement in Germany encompasses the same kind of clinical trials as mentioned in the scope of the Commission Guideline 2012/C302/03. The requirement also includes retrospective publication of a summary of trial results of clinical trials conducted as of August 6, 2004 (the date the 12th update of the AMG, which included Directive 2001/20/EC, came into force). The summary of results can be submitted in German or in English; data provision is in standard format (ICH E3, synopsis of trial results or publication).
PharmNet.Bund is a cooperative project of the German regulatory authorities – Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)) and Paul-Ehrlich-Institut (PEI) - and other federal offices or institutions. Clinical trial results are uploaded to the database of the portal PharmNet.bund by the sponsor, reviewed by the applicable German competent authority (BfArM, PEI), and then made publicly accessible by the competent authorities in the above mentioned portal.
The KKS-Network as representative of a network of German academic sponsors of clinical trials agrees to the need for transparency and therefore generally supports a requirement to publish summaries of results of clinical trials. This indeed has been realized according to the above mentioned legal requirements in Germany. After discussion with the German competent authority our academic member institutions will continue to report clinical trial results in accordance with German legal requirements to the portal PharmNet.bund. When the EU regulation 536/2014 will get into effect, German academic sponsors will submit clinical trial results to the EU electronic portal as foreseen in regulation 536/14.
Best regards,
Prof. Dr. med. Heiko von der Leyen
Competing interests: No competing interests