AUTH/2661/11/13: Member of the public v Ferring – clinical trial disclosure for Firmagon (degarelix)

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Key facts

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Case number	AUTH/2661/11/13
Parties	Anonymous, contactable member of the public v Ferring
Issue	Clinical trial disclosure (Firmagon/degarelix)
Source referenced in complaint	CMRO article “Clinical Trial Transparency: an assessment of the disclosure results of company-sponsored trials associated with new medicines approved recently in Europe” (published 11 November 2013)
Complaint received	21 November 2013
Case completed	24 March 2014
Appeal	No appeal
Product	Firmagon (degarelix)
First licensed/commercially available	March 2009 (Firmagon first licensed and commercially available in March 2009; further information stated 2 March 2009 in the US)
Key trial leading to breach	NCT00116753 (completed Nov 2006; disclosed Oct 2010; should have been disclosed by March 2010)
Other trials assessed	NCT00451958 (no breach; disclosed within 1 year of completion); NCT00946920 (no breach; unlicensed formulation with delayed disclosure); NCT00468286 (no breach; no UK involvement)
Breach clauses	Clause 9.1; Clause 21.3
No breach clauses	Clause 2 (and no breach findings for Clause 9.1/21.3 in relation to other trials as described)
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 results disclosure for Firmagon (degarelix), based on an ABPI-funded transparency study published in Current Medical Research & Opinion (CMRO) on 11 November 2013.
The CMRO study assessed publicly available sources (search window 27 December 2012 to 31 January 2013) and reported that some evaluable Firmagon studies were not disclosed within the expected timeframe.
The complainant alleged breaches of Clauses 2, 9 and 21 of the Code (the Authority also drew attention to Clauses 1.8 and 21.3 of the Second 2012 Edition and noted earlier Codes might be relevant).
Ferring responded trial-by-trial, by phase, and by applicable Code version, stating it used ClinicalTrials.gov as its primary registry per SOP and that some studies had delayed results reporting granted due to “certify new use” (eg, new dosing schedule or unlicensed formulation).
The Panel focused on the evaluable trials covered by the CMRO publication and assessed whether results were disclosed and whether disclosure was within the relevant one-year timeframe (based on first licensing/commercial availability and/or trial completion, and which Code/Joint Position applied).

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Breach found for late disclosure of trial NCT00116753 (completed November 2006; disclosed October 2010) because Firmagon was first licensed/commercially available in March 2009 and results were not disclosed by March 2010.
No breach for trial NCT00451958 (completed October 2011; disclosed October 2012) as it was disclosed within one year of completion.
No breach for trial NCT00946920 (completed March 2011) because it related to an unlicensed formulation and had delayed results disclosure granted due to “certify new use”; the Panel decided there was, as yet, no requirement to disclose results.
No breach for trial NCT00468286 because it had no UK involvement and therefore was outside the scope of the Code.
No breach of Clause 2 overall: for the late-disclosed trial, the Panel considered that because the data had been disclosed, Clause 2 was not breached.
The Panel noted additional studies not covered by the CMRO publication appeared to have been disclosed outside the one-year timeframe (NCT00268892, NCT00831233 and NCT00215683) and requested its concerns be drawn to Ferring’s attention; all results had been disclosed.

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Clause 21.3 – Breach (2008 Code) in relation to trial NCT00116753.
Clause 9.1 – Breach (delay meant high standards had not been maintained) in relation to trial NCT00116753.
Clause 2 – No breach.
Clause 21.3 – No breach (2011 Code) in relation to trial NCT00451958.
Clause 21.3 – No breach (2008 Code) in relation to trial NCT00946920.

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