AUTH/3071/9/18: Director v Novo Nordisk — Clinical trial disclosure (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3071/9/18
Parties	Director v Novo Nordisk
Topic	Clinical trial disclosure (EUCTR results posting)
Applicable Code	2016
Complaint received	12 September 2018
Case completed	15 May 2019
Appeal	No appeal
Trigger for case	BMJ paper (Goldacre et al, 12 Sept 2018) on EUCTR results reporting compliance
Key trial referenced	NN8226-4064 (NNC0109-0012 anti-IL-20 mAb; rheumatoid arthritis)
Registry metric cited	52 due trials; 51 with results; 98.1% reported (per Goldacre et al)
Company position	Trial withdrawn by 7 Aug 2014 before any subjects enrolled; no results available for reporting
Panel decision	No breach of Clauses 1.11, 2, 9.1; no breach of Clause 29 in relation to undertaking
Sanctions	None

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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The PMCPA Director opened a complaint (Paragraph 5.1) after a BMJ paper (Goldacre et al, 12 Sept 2018) assessed whether sponsors posted results to the EU Clinical Trials Register (EUCTR) within 12 months of completion (final compliance date cited: 21 Dec 2016).
The BMJ paper listed Novo Nordisk as having 52 “due” trials on EUCTR, with results posted for 51 (98.1%), implying one due trial without results on EUCTR.
Novo Nordisk identified the trial as NN8226-4064 (mechanism of action study of investigational anti-IL-20 mAb NNC0109-0012 in rheumatoid arthritis).
Novo Nordisk stated the project closed in Aug 2014 and the trial was withdrawn by 7 Aug 2014 before any subjects (including UK subjects) were enrolled; therefore, no results existed to report.
Novo Nordisk said withdrawal information was in EudraCT but not publicly visible on EUCTR; it could be seen on the company’s trial website.
Because Novo Nordisk had a prior ruling under the 2008 Code about late disclosure for Tresiba studies, the Authority also raised an alleged breach of an undertaking (Case AUTH/2906/11/16).

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No breach of the Code was found.
The Panel accepted that the trial was withdrawn before enrolment and that there were no results available for reporting.
No breach was found in relation to the prior undertaking (AUTH/2906/11/16).
The Panel made no ruling in relation to Clause 13.1 (it treated the issue pragmatically under Clause 9.1 and potentially Clause 1.11, but ultimately found no breach).

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