UCB: EU Clinical Trials Register results not posted on time (Director complaint) — AUTH/3091/9/18 | PMCPA Case

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Key facts

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Case	AUTH/3091/9/18
Parties	Director v UCB
Issue	Clinical trial disclosure (posting summary results on EU Clinical Trials Register within EC Guideline timeline)
Trigger	BMJ paper (Goldacre et al, 12 September 2018) ranking EUCTR results reporting
Complaint received	12 September 2018
Case completed	22 July 2019
Applicable Code	2016
Breach clauses	9.1
No breach clauses	1.11, 2, 9.1
Trials discussed	SP935, RA0134, RA0056, RA0057, CD0001
Panel findings (in scope)	RA0056 and RA0057 had UK sites and results did not appear to be published on EUCTR within the required timeframe
Appeal	No appeal (UCB declined opportunity to appeal out of time)
Sanctions	Undertaking received; additional sanctions not stated

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

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The PMCPA Director opened a complaint after a BMJ paper (Goldacre et al, 12 Sept 2018) ranked sponsors’ compliance with posting summary results to the EU Clinical Trials Register (EUCTR) by the EC Guideline timeline (final compliance date referenced: 21 December 2016).
The BMJ dataset showed UCB had 40 “due” trials and 35 with results posted (87.5%), implying 5 due trials without EUCTR results.
UCB identified the 5 trials as SP935, RA0134, RA0056, RA0057 and CD0001 and provided trial-by-trial context (cancellations/no enrolment, UK nexus, and out-licensing).
The Panel focused on whether results appeared to have been posted on EUCTR within the required timeframe, and whether the trials were within scope of the UK Code (UK nexus such as UK sites).

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Breach: Clause 9.1 for trial RA0056 (UK sites; results did not appear to be published on EUCTR within the required timeframe).
Breach: Clause 9.1 for trial RA0057 (UK sites; results did not appear to be published on EUCTR within the required timeframe).
No breach: Clauses 1.11, 9.1 and 2 for trial SP935 (cancelled before enrolment; no data collected).
No breach: Trial RA0134 (no UK involvement; outside scope of the UK Code).
No breach: Trial CD0001 (no UK involvement; outside scope of the UK Code; prematurely terminated with no patients enrolled).
The Panel made no ruling in relation to Clause 13.1 (it treated the EUCTR timing issue pragmatically under Clause 9.1).
No appeal (UCB accepted the Panel’s rulings and later declined an opportunity to appeal out of time).

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