AUTH/3093/9/18: Director v Roche — Clinical trial disclosure (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3093/9/18
Parties	Director v Roche
Topic	Clinical trial disclosure (EUCTR posting)
Applicable Code year	2016
Complaint received	12 September 2018
Case completed	16 May 2019
Appeal	No appeal
Finding	No breach
Clauses considered	1.11, 2, 9.1, 29
External source triggering review	BMJ paper: Goldacre et al (12 September 2018)
Roche EUCTR figures cited	596 total trials; 115 due; 100 with results; 87.0% reported; 15 shown as unreported
UK nexus assessment	14/15 trials: no UK involvement (out of scope); 1 trial with UK sites (2011-001891-21) terminated early with no UK patients recruited
Trial identifier referenced	EUCTR 2011-001891-21
Sanctions	None stated

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

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The Director opened a complaint (Paragraph 5.1) after a BMJ paper (Goldacre et al, 12 Sept 2018) assessed whether sponsors posted due trial results to the EU Clinical Trials Register (EUCTR) within 12 months (final compliance date referenced: 21 Dec 2016).
The BMJ paper reported that Roche had 596 trials on EUCTR; results were due for 115; 100 had results posted; 15 were shown as not reported (87.0% reported).
Because Roche had prior rulings about late disclosure (Kadcyla and Perjeta) an alleged breach of undertaking was also raised.
Roche stated that 14 of the 15 trials had no UK involvement (no UK centres/investigators/patients), and that the remaining trial (EUCTR 2011-001891-21) had UK sites but was prematurely terminated with no UK patients recruited and no results to report; the medicine was never licensed or commercially available.

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No breach was ruled in relation to the 14 trials because they had no UK involvement and were outside the scope of the UK Code.
No breach was ruled for the remaining trial (2011-001891-21) because it was prematurely terminated with no UK patients recruited and there were no results to report.
No breach of Clause 2 was ruled.
No breach of undertaking was found in relation to trial 2011-001891-21 (linked to Cases AUTH/2898/11/16 and AUTH/2901/11/16).

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