AUTH/3087/9/18: Director v GlaxoSmithKline — EU Clinical Trials Register (EUCTR) results posting (No breach after appeal)

📊

Key facts

⌄

Case number	AUTH/3087/9/18
Parties	Director v GlaxoSmithKline
Topic	Clinical trial disclosure (EUCTR results posting)
Source trigger	BMJ paper: Goldacre et al (published online 12 September 2018)
Complaint received	12 September 2018
Case completed	18 September 2019
Initial BMJ-reported GSK EUCTR metric	Due trials 293; due trials with results 260; % reported 88.7; 33 due trials without results (per Goldacre et al)
GSK-identified trials potentially missing EUCTR results	34
Out of scope (no UK involvement)	18 trials
Cancelled before enrolment (UK nexus)	11 trials (EUCTR 2004-005058-30; 2005-001122-87; 2007-000779-40; 2007-004025-20; 2007-005954-22; 2009-011782-92; 2010-019390-15; 2010-024087-17; 2011-000241-21; 2011-002818-37; 2014-001959-274)
Trials central to appeal	2011-005216-28 (vestipitant); 2011-005913-35 (umeclidinium/vilanterol)
Appeal Board view on EUCTR posting	Concerned about late EUCTR posting vs advised timelines, but exceptional circumstances meant no breach (results already publicly disclosed; EUCTR posting in March 2018 before complaint)
Final decision	No breach of the Code
Clauses considered (as listed)	1.11; 2; 9.1

Download the full case report (PDF)

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

📋

What happened

⌄

The PMCPA Director opened a complaint (Paragraph 5.1) after a BMJ paper reported that GlaxoSmithKline (GSK) had 33 “due trials” without results on EUCTR (reported disclosure rate 88.7%).
GSK reviewed the underlying data and said it identified 34 trials appearing to have results due but no EUCTR results posted.
Of those 34 trials, GSK said 18 had no UK involvement (no UK centres/investigators/patients).
Of the remaining 16 with a UK nexus, GSK said 11 were cancelled before enrolling any subjects (no results to report).
Of the remaining 5 with UK involvement and results:
- Two were exploratory imaging-method studies (not clinical trials of medicinal products): 2008-005288-33 and 2010-019832-11.
- One was an investigational medicine not approved in any market: 2011-005216-28 (vestipitant).
- Two were trials of licensed medicines: 2011-005913-35 (umeclidinium/vilanterol) and 2009-009885-15 (lapatinib combination; later divested to Novartis with responsibility transferred in 2015).
The Panel initially found that two trials (2011-005216-28 and 2011-005913-35) did not appear to have been posted to EUCTR within the advised timeframe and ruled breaches of Clause 9.1 (but not Clauses 1.11 or 2). GSK appealed.
On appeal, the Appeal Board noted both trials had been disclosed on GSK’s Clinical Study Register within 12 months of completion and published in the scientific literature, and that EUCTR posting occurred in March 2018 (before the BMJ paper and before the complaint was received).

⚖️

Outcome

⌄

No breach of the Code overall.
The Appeal Board overturned the Panel’s Clause 9.1 breach findings for trials 2011-005216-28 and 2011-005913-35.
Trials with no UK nexus were treated as out of scope for the UK Code.
Cancelled trials with no enrolled subjects were treated as having no results to report.

🔒

Unlock the full case analysis

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access

AUTH/3087/9/18: Director v GlaxoSmithKline — EU Clinical Trials Register (EUCTR) results posting (No breach after appeal)

Key facts

What happened

Outcome

Unlock the full case analysis

📰 Weekly PMCPA Case Breakdown