Bayer: delayed disclosure of Phase I Xofigo trial results (AUTH/2908/11/16)

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Key facts

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Case number	AUTH/2908/11/16
Parties	PMCPA Director v Bayer
Issue	Clinical trial disclosure (Xofigo)
Complaint received	06 December 2016
Completed	14 March 2017
Appeal	No appeal
Applicable Code year	2012
Medicine	Xofigo (radium-223 dichloride)
Trial at issue	NCT00667537 (Trial #15302), Phase I, UK, 6 patients, completed 3 December 2008
Trigger date used by Panel	First licensed and commercially available: May 2013
Required disclosure deadline (Panel view)	By May 2014
Findings	Breach Clause 13.1 and 9.1; No breach Clause 2
Sanctions	Undertaking received

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

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A CMRO transparency study (published online 25 Nov 2016) assessed whether results of company-sponsored trials linked to EMA 2013 approvals were disclosed within 12 months and by 31 Jul 2015.
The PMCPA Director initiated a complaint (Paragraph 5.1) after the study suggested one evaluable Phase I Xofigo (radium-223 dichloride) trial had not been disclosed within the 12-month timeframe.
The trial was NCT00667537 (Trial #15302): Phase I, open-label dosimetry/bio-distribution/pharmacokinetic study in the UK (6 patients), completed 3 Dec 2008.
Xofigo was first licensed and commercially available in May 2013 (US); UK commercialisation Jan 2014.
Bayer argued the trial was originally out of scope under Joint Position 2008 and that Joint Position 2009 “implementation dates” language related to registries meant it did not trigger results posting for this older Phase I trial.
The Panel considered Bayer had conflated registry listing requirements with results database posting requirements; for a licensed and commercially available medicine, Joint Position 2009 required disclosure of Phase I trials regardless of completion date.
Bayer stated results were available via four clinical publications (2011–2015), with full trial results on clinicaltrials.gov (online July 2015; print Sept 2015) and a results synopsis added to EudraCT in May 2016.

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Breach of Clause 13.1 (clinical trial disclosure) for failure to post results by May 2014 (one year after first licensing/commercial availability in May 2013).
Breach of Clause 9.1 (high standards) due to delay in disclosure.
No breach of Clause 2 (as the data had been disclosed by the time of the Panel’s consideration).

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