AUTH/2666/11/13: Member of the public v Sanofi — Clinical trial disclosure for Multaq and Jevtana (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2666/11/13
Complainant	Anonymous, contactable member of the public
Company	Sanofi
Issue	Clinical trial disclosure (Multaq and Jevtana) referenced in ABPI-funded CMRO publication
Complaint received	18 November 2013 (HTML case page) / 21 November 2013 (PDF narrative)
Case completed	20 March 2014
Appeal	No appeal
Applicable Code year	2012 (case page); Panel applied relevant earlier Codes (2008/2011) depending on timing
Clauses considered	Clause 2; Clause 9.1; Clause 21.3
Outcome	No breach of the Code
Products	Jevtana (cabazitaxel); Multaq (dronedarone)
Notable trial examples (as discussed)	Jevtana: NCT00417079 (results disclosed 20 Sept 2010). Multaq: NCT00259428; NCT00174785; NCT01140581 (results disclosed May 2013); NCT01151137 (results disclosed 14 Sept 2012).

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 study published in Current Medical Research & Opinion (11 Nov 2013).
The study (“Clinical Trial Transparency…”) searched public sources (27 Dec 2012–31 Jan 2013) and reported disclosure rates for trials linked to recently EMA-approved medicines; detailed product-level data were available via a linked website.
The complainant alleged companies (including Sanofi) had not disclosed clinical trial results for licensed products in line with the ABPI Code, citing Clauses 2, 9 and 21.
Sanofi argued the matter was outside the UK Code’s scope because registration/disclosure/publication activities for the relevant global trials were managed outside the UK and none were conducted by the Sanofi UK affiliate; it nevertheless provided trial-by-trial information for studies with UK sites/investigators.
The Panel considered whether the UK Code applied (UK company involvement or UK centres/investigators/patients) and assessed the disclosure timing against the relevant Joint Positions and Code editions.
Products/trials considered: Jevtana (cabazitaxel) and Multaq (dronedarone), including specific trials with UK involvement (e.g., Jevtana NCT00417079; Multaq NCT00259428, NCT00174785, NCT01140581, NCT01151137).

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No breach of the Code was ruled.
No breach of Clause 21.3 (clinical trial disclosure) and consequently no breach of Clauses 9.1 and 2.
For Jevtana: the one UK-involvement trial (NCT00417079) had results disclosed within one year of first approval; trials with no UK involvement were considered outside the UK Code’s scope.
For Multaq: one older trial completed before Jan 2005 did not require disclosure under the applicable Joint Position; other trials were disclosed within required timelines or were treated as permissible schedule adjustment to avoid compromising peer-reviewed publication under the Joint Position (2008).

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