AUTH/3071/9/18: Director v Novo Nordisk (clinical trial disclosure)

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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 year	2016
Complaint received	12 September 2018
Case completed	15 May 2019
Appeal	No appeal
Trigger for case	BMJ paper (Goldacre et al, 12 September 2018) on EUCTR results reporting compliance
Allegation	One “due” Novo Nordisk trial appeared not to have results posted on EUCTR within required timeframe; alleged breach of undertaking also raised
Trial referenced	NN8226-4064 (NNC0109-0012, anti-IL-20 mAb; rheumatoid arthritis)
Key factual finding	Trial withdrawn by 7 August 2014 before any subjects (including UK subjects) were enrolled; no results available for reporting
Result	No breach
Clauses considered/listed	1.11, 2, 9.1, 29
Sanctions	None

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

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The PMCPA Director initiated a complaint (under Paragraph 5.1 of the Constitution and Procedure) after a BMJ paper (Goldacre et al, 12 Sept 2018) ranked sponsors’ compliance with posting results to the EU Clinical Trials Register (EUCTR).
The BMJ analysis showed Novo Nordisk had 52 “due” trials on EUCTR, with 51 having results posted (98.1%), implying one due trial without posted results.
The trial identified by Novo Nordisk was NN8226-4064 (mechanism of action of NNC0109-0012, anti-IL-20 mAb, in rheumatoid arthritis).
Novo Nordisk stated the project closed in Aug 2014 and the trial was withdrawn by 7 Aug 2014 before any subjects were enrolled (including no UK subjects), so there were no results available to report.
An alleged breach of an earlier undertaking was also raised because Novo Nordisk had previously been ruled in breach of the 2008 Code for delayed disclosure relating to Tresiba.

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No breach of the Code was found.
The Panel ruled no breach of Clauses 1.11, 9.1 and 2 because the trial was withdrawn before enrolment and there were no results available for reporting.
Given the above, the Panel ruled no breach of Clauses 29, 9.1 and 2 in relation to the alleged breach of undertaking (Case AUTH/2906/11/16).
The Panel made no ruling in relation to Clause 13.1 (it took a pragmatic approach and considered the matter under Clause 9.1 instead).

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