AUTH/3097/9/18: Director v Teva — Clinical trial disclosure on EUCTR (No breach after appeal) | PMCPA Case

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Key facts

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Case number	AUTH/3097/9/18
Parties	Director v Teva
Topic	Clinical trial disclosure (EUCTR)
Source trigger	BMJ paper: Goldacre et al (published online 12 September 2018)
Complaint received	12 September 2018
Applicable Code	2016
Teva EUCTR stats in paper	Total trials 81; due trials 25; due with results 18; % reported 72.0
Trials discussed (UK nexus)	116B8 (EudraCT 2009-010562-31); LAQ-MS-306 (EudraCT 2013-002082-19); QV-001/2007-Pae (EudraCT 2007-007455-14)
Panel decision	Initially ruled breaches of Clause 9.1 for trials 116B8 and QV-001/2007-Pae; no breach for LAQ-MS-306; no breach for trials with no UK involvement
Appeal outcome	Appeal successful; no breach of the Code (including no breach of Clause 9.1)
Clauses cited	1.11, 2, 9.1
Case completion date	22 January 2020

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

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What happened

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The PMCPA Director took up a complaint (Paragraph 5.1) after a BMJ paper (Goldacre et al, 12 Sept 2018) assessed whether sponsors posted trial results to the EU Clinical Trials Register (EUCTR) by the EC guideline timeline (deadline referenced: 21 Dec 2016).
Goldacre et al reported Teva had 81 total trials on EUCTR; 25 were “due”; 18 had results posted (72% reported), leaving 7 due trials apparently without EUCTR results.
Teva said four of the seven trials had no UK involvement (no UK nexus), so were outside the UK ABPI Code’s scope.
Teva identified three UK-nexus trials in the BMJ dataset:
- Trial 116B8 (EudraCT 2009-010562-31): completed Oct 2010; results presented 2011 and published 2012; results submitted to clinicaltrials.gov 13 May 2013; Teva said EUCTR posting was missed until the compliance tracker went live (13 Sept 2018) and results were submitted to EUCTR on 2 Oct 2018.
- Trial LAQ-MS-306 (EudraCT 2013-002082-19): withdrawn with no subjects enrolled; Teva said no results existed to post and EUCTR had no public mechanism to show “never initiated/no subjects”.
- Trial QV-001/2007-Pae (EudraCT 2007-007455-14): completed Dec 2008; results presented 2010 and published 2011; Teva said EUCTR posting was an unintended historical oversight discovered via the tracker and it would prepare the EUCTR results summary as soon as possible.
The Panel considered the issue primarily under Clause 9.1 (high standards), noting the Code did not explicitly refer to EUCTR posting and that Goldacre et al assessed EC guideline compliance rather than Joint Positions under Clause 13.1.
After other related cases were appealed, Teva was offered (and accepted) an opportunity to appeal out of time; the Appeal Board then reviewed Teva’s case.

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Outcome

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Final outcome (after appeal): No breach of the Code.
The Appeal Board found that, in the exceptional circumstances, late EUCTR posting of results for two trials as part of a retrospective exercise did not warrant a breach of Clause 9.1.
Four trials with no UK involvement were outside the scope of the UK Code (no breach considered for those).
Trial LAQ-MS-306 (withdrawn/no subjects) attracted no breach findings.

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AUTH/3097/9/18: Director v Teva — Clinical trial disclosure on EUCTR (No breach after appeal)

Key facts

What happened

Outcome

Clauses

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