AUTH/3069/9/18: Director v Bayer — Clinical trial disclosure (EUCTR) (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3069/9/18
Parties	Director v Bayer
Topic	Clinical trial disclosure (EUCTR)
Source trigger	BMJ paper: “Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource” (Goldacre et al, published online 12 September 2018)
Complaint received	12 September 2018
Case completed	15 May 2019
Applicable Code year	2016
Appeal	No appeal
Finding	No breach
Clause(s)	1.11, 2, 9.1, 29
Registry/trial at issue	EudraCT 2012-004857-10 (authorised 19 September 2013; cancelled before any patients enrolled)
BMJ-reported Bayer EUCTR stats	Total trials on EUCTR: 274; Due trials: 72; Due trials with results: 71; % reported: 98.6
Key remediation described	Deleted completion date and added statement on EUCTR/EudraCT: “Trial was withdrawn before start of recruitment, therefore no trial results available”
Alleged breach of undertaking	Raised due to prior case (AUTH/2908/11/16) but not upheld

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

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The Director opened a complaint (under Paragraph 5.1) after a BMJ paper (Goldacre et al, 12 Sept 2018) assessed whether sponsors posted results on the EU Clinical Trials Register (EUCTR) within 12 months of completion (final compliance date cited: 21 Dec 2016).
The BMJ paper’s table showed Bayer had 72 “due trials”, 71 with results posted (98.6%), implying one “due” trial without results on EUCTR.
Bayer identified the trial as EudraCT 2012-004857-10 (involving Nifedipine gastrointestinal therapeutic system (GTIS) and Candesartan Cilexetil in combination), authorised 19 Sept 2013 but cancelled before any patients were enrolled—so no results existed to post.
Bayer explained EUCTR/EudraCT lacked functionality to mark a trial as “withdrawn” where recruitment never started; “completed” was the only available designation, which likely caused the BMJ tool to treat it as “due”.
After the complaint, Bayer worked with the German competent authority to amend the EUCTR entry by deleting the completion date and adding: “Trial was withdrawn before start of recruitment, therefore no trial results available”.
An alleged breach of a prior undertaking was also raised because Bayer had previously been ruled in breach of the 2008 Code regarding disclosure timelines for Xofigo studies (Case AUTH/2908/11/16).

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No breach of the Code.
No breach of Clauses 1.11, 9.1 and 2 (Panel found there were no results to publish).
No breach of Clauses 29, 9.1 and 2 in relation to the alleged breach of undertaking (because there was no underlying failure to disclose results).
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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