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

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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)
Applicable Code year	2016
Complaint received	12 September 2018
Case completed	15 May 2019
Appeal	No appeal
Finding	No breach
Clauses considered/listed	1.11, 2, 9.1, 29
Core allegation	One Bayer “due trial” on EUCTR appeared to have no results posted within required timeframe.
Trial at issue	EudraCT 2012-004857-10 (authorised 19 September 2013; withdrawn/cancelled before any patients enrolled)
Registry issue	EudraCT/EUCTR lacked functionality to label withdrawn-before-recruitment trials as “withdrawn”; “completed” designation contributed to being treated as “due”.
Corrective action described	Completion date deleted; statement added: “Trial was withdrawn before start of recruitment, therefore no trial results available”.
Sanctions	None

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

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The PMCPA Director initiated a complaint (Paragraph 5.1) after a BMJ paper (Goldacre et al, 12 Sept 2018) assessed whether sponsors posted results to the EU Clinical Trials Register (EUCTR) within 12 months of completion (final compliance date cited: 21 Dec 2016).
The BMJ analysis listed Bayer as having 274 trials on EUCTR, 72 “due trials”, 71 with results posted (98.6%), implying 1 “due” trial without results.
The trial identified by Bayer was EudraCT 2012-004857-10 (involving nifedipine gastrointestinal therapeutic system (GTIS) and candesartan cilexetil in combination), authorised 19 Sept 2013 but cancelled/withdrawn before any patients were enrolled.
Bayer explained EUCTR/EudraCT system limitations: for withdrawn-before-recruitment trials, “withdrawn” was not available and “completed” was the only designation, which likely caused the BMJ tool to treat it as “due”.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with the German competent authority to amend the EUCTR entry by deleting the completion date and adding: “Trial was withdrawn before start of recruitment, therefore no trial results available”.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 delayed disclosure of Xofigo study results (Case AUTH/2908/11/16).

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No breach of the Code was ruled.
The Panel ruled no breach of Clauses 1.11, 9.1 and 2 because there were no results to publish (trial withdrawn before recruitment).
Given that, the Panel ruled no breach of Clauses 29, 9.1 and 2 in relation to the alleged breach of undertaking from Case AUTH/2908/11/16.
The Panel made no ruling in relation to Clause 13.1 (it considered the matter more appropriately under Clause 9.1 and potentially Clause 1.11).
No appeal.

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