AUTH/3088/9/18: Director v Ipsen (Clinical trial disclosure) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/3088/9/18
Parties	Director v Ipsen
Issue	Clinical trial disclosure (posting results on EUCTR within required timeframe)
Trigger	BMJ paper: Goldacre et al (published online 12 September 2018)
Applicable Code year	2016
Complaint received	12 September 2018
Case completed	15 May 2019
Allegation basis	3 of Ipsen’s due trials not reported on EUCTR; disclosure percentage stated as 88.0%
Trials discussed (EudraCT)	2006-007055-41; 2013-002321-34; 2010-020742-10
Panel decision	No breach (two trials out of scope due to no UK involvement; one trial cancelled before enrolment so no results to report)
Clauses considered	1.11, 2, 9.1 (no ruling made in relation to Clause 13.1)
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) after a BMJ paper (Goldacre et al, published online 12 September 2018) assessed whether sponsors posted due trial results to the EU Clinical Trials Register (EUCTR) within 12 months (final compliance date referenced: 21 December 2016).
The BMJ paper listed Ipsen as having 74 total trials on EUCTR, 25 due trials, 22 with results posted (88.0%), implying 3 due trials without results on EUCTR.
Ipsen explained:
- EudraCT 2006-007055-41 (Decapeptyl SR 22.5mg) had no UK sites/patients and was conducted only in Lithuania.
- EudraCT 2013-002321-34 (Azzalure) had no UK sites/patients and was conducted only in Germany.
- EudraCT 2010-020742-10 (NutropinAq and Increlex) was planned to include UK sites but was cancelled on 30 June 2011 before any patients were enrolled; Ipsen said there were no results to publish and the EUCTR record appeared not to have been properly “closed down”.
The Panel considered whether the matters fell within the scope of the UK Code (i.e., whether there was a UK nexus such as UK centres/investigators/patients or activity on behalf of a UK company).

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No breach ruled for the two trials with no UK involvement (out of scope of the UK Code).
No breach ruled for the cancelled trial because it ended before enrolment and therefore had no results to report.
No breach of Clauses 1.11, 9.1 and 2.
No ruling was made in relation to Clause 13.1.

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