AUTH/3099/9/18: Director v Allergan — late posting of clinical trial results on EUCTR | PMCPA Case

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Key facts

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Case	AUTH/3099/9/18
Parties	Director v Allergan
Topic	Clinical trial disclosure (EUCTR results posting timelines)
Applicable Code year	2016
Complaint received	12 September 2018
Case completed	18 July 2019
Appeal	No appeal
Trigger	BMJ paper (Goldacre et al 2018) and PMCPA Director action under Paragraph 5.1
Goldacre et al data for Allergan	Total trials on EUCTR: 115; Due trials: 46; Due trials with results: 30; % reported: 65.2; Unreported due trials cited: 16
Scope finding	12 of 16 trials: no UK involvement, out of scope of UK Code
Breaches	Clause 9.1 (late EUCTR posting) for three UK-nexus trials
No breach findings	Clause(s) 1.11 and 2 (and no breach for out-of-scope trials)
Sanction	Undertaking received

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) ranked sponsors’ compliance with posting results to the EU Clinical Trials Register (EUCTR) by the EC Guideline timeline (final compliance date referenced: 21 Dec 2016).
Goldacre et al reported Allergan had 46 “due” trials on EUCTR, with 30 posted (65.2%), and 16 due trials without results on EUCTR at the time of the dataset.
Allergan identified the 16 trials and argued most were out of scope of the UK Code due to no UK involvement.
The Panel treated the issue as whether results were posted on EUCTR within the advised timeframe, and considered it under Clause 9.1 (and potentially Clause 1.11), not Clause 13.1.
Of the 16 trials, the Panel accepted that 12 had no UK sites/investigators/UK involvement and were therefore outside the scope of the UK Code.
For the remaining trials with a UK nexus, the Panel found EUCTR posting occurred in 2018 (after the advised timeline), even where results had been published elsewhere earlier (eg poster, clinicaltrials.gov, manuscript).

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Breach ruled: Clause 9.1 (for late EUCTR posting) in relation to three trials with a UK nexus.
No breach ruled: Clause 1.11 (no evidence of a formal finding by a judicial authority/appropriate body that relevant laws/regulations were not complied with).
No breach ruled: Clause 2 (Panel did not consider the circumstances warranted a Clause 2 breach given results were now disclosed on EUCTR and had been published elsewhere).
No breach ruled (scope): 12 of the 16 trials were considered out of scope due to no UK involvement.
No appeal (Allergan accepted the Panel’s rulings and later declined an out-of-time appeal opportunity).

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