AUTH/2657/11/13: Member of the public v AstraZeneca – Clinical trial disclosure for Iressa (no breach) | PMCPA Case

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Key facts

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Case number	AUTH/2657/11/13
Complainant	Anonymous, contactable member of the public
Company	AstraZeneca
Product / topic	Clinical trial disclosure (Iressa / gefitinib)
Complaint received	21 November 2013
Case completed	20 March 2014
Applicable Code year	2012
Clauses cited	2, 9.1 and 21.3
Outcome	No breach
Appeal	No appeal
Sanctions	None
Key context noted by Panel	Iressa first approved/commercially available in Japan in 2002; many trials completed before 1 November 2008; investigator-sponsored studies not in scope; local affiliate responsibility evidenced via SOPs

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, referencing a transparency study published in Current Medical Research & Opinion (CMRO) on 11 November 2013.
The CMRO study assessed disclosure/registration across publicly available sources (search window 27 December 2012 to 31 January 2013) for trials linked to new medicines approved by EMA in 2009–2011; product-level detail was provided via a linked website.
The complainant alleged AstraZeneca (among others) had not disclosed Iressa (gefitinib) trial results in line with ABPI expectations and alleged breaches of Clauses 2, 9 and 21 of the Code.
The CMRO-linked data for Iressa suggested 29 studies were not disclosed “in timeframe” (56% disclosure in timeframe) and that 12 studies were not disclosed at all by 31 January 2013 for trials completed by end January 2012 (84% disclosed by 31 January 2013).
AstraZeneca responded that many studies were outside Code requirements (eg, completed before relevant Code/joint position dates), some were investigator-sponsored (not AstraZeneca’s responsibility), some were non-interventional, and two remaining undisclosed overseas local studies were the responsibility of local affiliates with responsibilities set out in SOPs.

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No breach of Clause 21.3 (clinical trial disclosure) of the 2008 Code for the bulk of studies because they completed before 1 November 2008 when the relevant Code requirements took effect.
No breach for investigator-sponsored studies (15 trials) because they were outside the scope of Clause 21.3 (responsibility sits with the study sponsor, not AstraZeneca).
No breach for a Thailand non-interventional study completed August 2010 because results were disclosed on AstraZeneca’s website in November 2010 (within one year) and Joint Position 2005 appeared not to require disclosure of non-interventional trial results.
Two trials remained undisclosed at the time considered (Taiwan completed August 2009; Canada completed August 2011), but the Panel ruled no breach because responsibility for disclosure was clearly assigned to local companies in AstraZeneca SOPs (Taiwan assessed under 2008 Code; Canada under 2011 Code).
Consequently, no breach of Clauses 9.1 and 2 (as alleged) in relation to the relevant Codes.

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