Amgen: delayed clinical trial results disclosure for Nplate (romiplostim) – breach of Clauses 21.3 and 9.1 (AUTH/2667/11/13) | PMCPA Case

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Key facts

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Case number	AUTH/2667/11/13
Complainant	Anonymous contactable member of the public
Company	Amgen
Issue	Clinical trial disclosure (Nplate and Prolia)
Products	Nplate (romiplostim); Prolia (denosumab)
Complaint received	18 November 2013
Case completed	24 March 2014
Appeal	No appeal
Applicable Code year (per case page)	2012
Breach clauses (per case page)	9.1 and 21.3
Key trial cited in breach finding	NCT00415532 (completed July 2009; disclosed October 2010)
Other Nplate trial considered	NCT00472290 (completed Dec 2011; disclosed Dec 2012) – no breach
Prolia outcome	No breach (trials cited had no UK involvement; out of scope)
Sanction	Undertaking received

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

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An anonymous, contactable member of the public complained about clinical trial disclosure performance referenced in an ABPI-funded paper: Clinical Trial Transparency: an assessment of the disclosure results of company-sponsored trials associated with new medicines approved recently in Europe (CMRO, 11 Nov 2013).
The paper assessed publicly available sources for trial registration/results disclosure (search window 27 Dec 2012 to 31 Jan 2013) and provided product-level tables via a linked website, including for Amgen’s Nplate (romiplostim) and Prolia (denosumab).
The complainant alleged breaches of Clauses 2, 9 and 21 of the Code (PMCPA also drew attention to Clauses 1.8 and 21.3 of the Second 2012 Edition, noting earlier Codes might be relevant).
For Nplate, the Panel focused on UK-involved trials and the applicable Code/joint position timing. One UK-involved trial (NCT00415532) completed July 2009 and was disclosed October 2010 (late vs the one-year expectation).
For Prolia, the two evaluable trials cited as not disclosed “within timeframe” had no UK involvement; the Panel treated them as out of scope of the UK Code.

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Breach for Nplate: Clause 21.3 (2008 Code) for late disclosure of trial NCT00415532; and Clause 9.1 (2008 Code) for failure to maintain high standards due to the delay.
No breach for Nplate trials with no UK involvement (out of scope of the UK Code).
No breach for Nplate trial NCT00472290 (completed Dec 2011; disclosed Dec 2012) under the 2011 Code, including no breach of Clauses 21.3, 9.1 and 2.
No breach for Prolia: the two evaluable trials cited had no UK involvement and were therefore out of scope of the UK Code.
No breach of Clause 2 was ruled in relation to the late-disclosed Nplate trial because results had been disclosed and the Panel did not consider the matter warranted a Clause 2 finding.
The Panel decided not to make a ruling on Clause 1.8 in this complaint, noting it was effectively covered by other rulings.

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