AUTH/2670/11/13: Member of the public v Otsuka — Clinical trial disclosure for Samsca (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2670/11/13
Complainant	Anonymous, contactable member of the public
Company	Otsuka
Product	Samsca (tolvaptan)
Issue	Clinical trial disclosure / transparency (alleged non-disclosure of results within timeframe)
Complaint received	18 November 2013 (case report also states 21 November 2013)
Case completed	20 March 2014
Appeal	No appeal
Applicable Code year (PMCPA page)	2012
Panel applied (for key disclosure assessment)	2008 Code / Joint Position 2005 (because Samsca first approved 5 May 2009)
Clauses considered (as listed)	2, 9.1 and 21.3
Outcome	No breach
Notable evidence referenced	UK-nexus trial NCT00071331; results linked from ClinicalTrials.gov to JAMA publication (Konstam et al, March 2007)

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

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An anonymous, contactable member of the public complained about alleged non-disclosure of clinical trial results for Samsca (tolvaptan), based on a transparency assessment published in Current Medical Research & Opinion (CMRO) on 11 November 2013.
The CMRO study assessed publicly available sources for trial registration/results disclosure (search window 27 December 2012 to 31 January 2013) for new medicines approved by EMA in 2009–2011; product-level detail was provided via a linked website (not in the journal article itself).
The complainant alleged breaches of Clauses 2, 9 and 21 of the Code (the case record lists Clause(s) 2, 9.1 and 21.3).
For Samsca, the CMRO-linked dataset suggested a low “disclosed in timeframe” percentage (36%) and that some evaluable studies were not disclosed within the defined timeframe.
Otsuka UK stated it did not sponsor GCP studies or investigator-initiated studies in the UK; global trials were organised/funded/managed outside the UK. Otsuka provided a confidential list of tolvaptan trials and identified only one trial with a UK nexus (NCT00071331), with results linked on ClinicalTrials.gov to a JAMA publication (Konstam et al, March 2007).
The Panel also queried additional trials; Otsuka stated some had no UK involvement and others were Phase 1/healthy volunteer and/or used non-approved formulations and/or pre-dated certain reporting expectations.

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No breach of the Code was found.
No breach of Clause 21.3 (2008 Code) in relation to the UK-involved trial, as it was published within one year of Samsca being first approved and commercially available (first approved 5 May 2009; UK-nexus trial completed July 2006; published March 2007).
For three multicentre international trials with no UK involvement, the Panel ruled the matter was out of scope of the UK Code and therefore no breach.
For seven other trials described as Phase 1/healthy volunteer and/or using different (non-licensed) formulations, the Panel considered publication preferable but, on the information provided, found no requirement to disclose under the applicable framework (Joint Position 2005) and therefore no breach of Clause 21.3, and consequently no breach of Clauses 9.1 and 2.

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