AUTH/3090/9/18: Director v Novartis (clinical trial disclosure) – No breach | PMCPA Case

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Key facts

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Case	AUTH/3090/9/18
Parties	Director v Novartis
Issue	Clinical trial disclosure (posting results on EUCTR within required timelines)
Source trigger	BMJ paper: Goldacre et al (12 September 2018)
Applicable Code year	2016
Complaint received	12 September 2018
Case completed	15 May 2019
Outcome	No breach
Clauses considered (as listed)	1.11; 2; 9.1; 29
Appeal	No appeal
Sanctions	None stated
Notable data point	BMJ reported Novartis EUCTR disclosure rate 87.7% (415/473 due trials with results), implying 58 due trials without results

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

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The Director took up a BMJ paper (Goldacre et al, 12 Sept 2018) assessing whether sponsors posted trial results to the EU Clinical Trials Register (EUCTR) within 12 months of completion (final compliance date stated as 21 December 2016).
The BMJ paper listed sponsor-level reporting rates; for Novartis it reported 1,260 total trials on EUCTR, 473 “due trials”, 415 “due trials with results” (87.7%), implying 58 due trials without results.
The PMCPA asked Novartis to consider Clauses 2, 9.1, 1.11 and 13.1, and also raised an alleged breach of undertaking due to a prior disclosure-related case (AUTH/2662/11/13).
Novartis said it could not obtain the exact EUCTR “snapshot” used by the BMJ authors and relied on internal Global Disclosure team reviews.
Novartis’ own review (23 Oct 2018) showed 1,304 studies, 497 due trials, 473 due trials with results (implying 24 due trials without results), many of which were outside UK scope or did not require results (eg cancelled with no patients, ongoing sub-study, expanded access programme).
Novartis also described EUCTR system/data issues and a long-running discussion with EMA about errors in EUCTR postings; it stated results for certain trials were available on CT.gov and the Novartis Clinical Trial Results website, and later released EUCTR postings with signposting notes.

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No breach of the Code was ruled.
The Panel considered the alleged failure to publish results in line with Commission Guideline timelines as more appropriately considered under Clause 9.1 (and potentially Clause 1.11), and made no ruling in relation to Clause 13.1.
Many trials cited were found to be out of scope of the UK Code due to no UK involvement, or had circumstances meaning results were not due/required (eg cancelled with no patients, ongoing trial, expanded access programme).
For trials with UK involvement where EUCTR posting appeared delayed, the Panel accepted explanations including EMA/EUCTR system issues and exceptional circumstances; no breach of Clauses 1.11, 9.1 and 2 was ruled.
No breach of undertaking was found (no breach of Clause 29, 9.1 and 2 in relation to the undertaking from AUTH/2662/11/13).

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