AUTH/3085/9/18: Director v Biogen — Clinical trial disclosure (EUCTR) — No breach | PMCPA Case

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Key facts

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Field	Details
Case number	AUTH/3085/9/18
Parties	Director v Biogen
Topic	Clinical trial disclosure (EUCTR)
Source trigger	BMJ paper: Goldacre et al (12 September 2018) on EUCTR results reporting compliance
Complaint received	12 September 2018
Case completed	15 May 2019
Applicable Code year	2016
Allegation basis	3 “due” Biogen trials appeared unreported on EUCTR (Biogen disclosure rate shown as 91.4%)
Trials discussed	109MS405; 109MS309; TYNERGY
Company explanation	Two trials ended before enrolment (no results). TYNERGY had no UK investigators/patients; results published in journals; EUCTR posting completed 8 Feb 2019 after internal review.
Decision	No breach
Clauses considered/listed	1.11, 2, 9.1, 29
Sanctions	None stated
Appeal	No appeal

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

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The PMCPA Director opened a complaint (under Paragraph 5.1) after a BMJ paper (Goldacre et al, 12 Sept 2018) assessed whether sponsors posted results to the EU Clinical Trials Register (EUCTR) within 12 months of completion (final compliance date cited: 21 Dec 2016).
The BMJ analysis showed Biogen had 35 “due” trials, 32 with results posted (91.4%), implying 3 due trials without EUCTR results.
Biogen identified the three trials as 109MS405, 109MS309 and TYNERGY.
Biogen said 109MS405 and 109MS309 ended before any patients were enrolled (no data collected; no results to report).
For TYNERGY, Biogen Idec was sponsor; the trial completed 30 June 2011. Biogen stated there were no UK investigators and no UK patients.
Biogen said TYNERGY results were published in journals (from 21 March 2013) and later posted on EUCTR on 8 Feb 2019 after an internal review found Sweden had categorised the study as interventional (triggering EUCTR posting expectations).

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No breach of the Code (Applicable Code year: 2016).
No breach of Clauses 1.11, 9.1 and 2 in relation to trials 109MS405 and 109MS309 because no subjects were enrolled and there were no results to report.
For TYNERGY, the Panel considered (on the limited information) there was no UK involvement; therefore it was outside the scope of the UK Code and no breach was ruled.
The Panel made no ruling in relation to Clause 13.1 (it considered the matter more appropriately under Clause 9.1 and potentially 1.11).

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