AUTH/3070/9/18: Director v Johnson & Johnson (Janssen) — Clinical trial disclosure on EUCTR (no breach)

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Key facts

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Case number	AUTH/3070/9/18
Case reference	Director v Johnson & Johnson
Complainant	Director
Respondent/company	Janssen (member company of the ABPI for the Janssen Pharmaceutical Companies of Johnson & Johnson)
Product(s)	Not stated (Goldacre et al did not mention products). Janssen stated trial 2011-000653-23 investigated Sirturo (bedaquiline); trial 2009-011250-17 investigated a medicine not licensed or commercially available anywhere in the world.
Material/channel	EU Clinical Trials Register (EUCTR) results posting; BMJ publication (Goldacre et al 2018) and associated online audit tool
Key issue	Apparent non-disclosure on EUCTR of results for two due trials attributed to Johnson & Johnson; whether this breached the ABPI Code (including scope/UK nexus and whether there were results to report)
Dates (received/completed if stated)	Complaint received: 12 September 2018; Case completed: 15 May 2019
Appeal	Not stated
Code year	2016
Breaches/clauses	No breach. Clauses considered: 1.11, 9.1, 2 (no breach); Clause 13.1 (no ruling made).
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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What happened

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A British Medical Journal paper (Goldacre et al, published online 12 September 2018) assessed whether sponsors posted results on the EU Clinical Trials Register (EUCTR) within 12 months of completion (final compliance date referenced as 21 December 2016).
The paper listed sponsors with more than 50 trials on EUCTR and reported Johnson & Johnson as having 108 due trials, 106 with results, and 98.1% reported (two due trials shown as not reported on EUCTR).
The Director took up the matter as a complaint under Paragraph 5.1 of the Constitution and Procedure, on the basis that Johnson & Johnson might have breached the Code.
Janssen (the ABPI member company for the Janssen Pharmaceutical Companies of Johnson & Johnson) responded that the two trials were EudraCT 2009-011250-17 and EudraCT 2011-000653-23.
Janssen submitted that EUCTR was not fully accurate for these trials because the relevant National Competent Authority (NCA) had not updated the trial status, despite Janssen’s requests, to reflect that no patients were recruited and therefore there were no results to report.
For EudraCT 2009-011250-17, Janssen submitted the UK had trial sites but the trial was cancelled on 14 July 2010 with no patients screened or enrolled.
For EudraCT 2011-000653-23, Janssen submitted the trial was cancelled on 19 December 2013 with no patients screened or enrolled, and that there was no UK company involvement and no UK centres, investigators or patients.
The Panel considered scope: only matters with a UK nexus would be within the scope of the UK Code.
The Panel considered the subject matter (failure to publish results on EUCTR under Commission Guideline 2012/C302/03) was more appropriately considered under Clause 9.1 (and potentially Clause 1.11) rather than Clause 13.1, and made no ruling under Clause 13.1.

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Outcome

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For trial EudraCT 2009-011250-17, the Panel ruled no breach of Clauses 1.11, 9.1 and 2, noting the trial was cancelled with no patients screened or enrolled and therefore there were no clinical trial results to report.
For trial EudraCT 2011-000653-23, the Panel ruled no breach of the Code, noting it was cancelled with no patients screened or enrolled and that, as there was no UK involvement, the matter did not come within the scope of the UK Code.
Overall case outcome: No breach of the Code.

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Clauses

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Clauses considered by the Authority at the outset: Clauses 2, 9.1, 1.11 and 13.1 (2016 Code referenced as applicable for the proceedings).
Panel approach: alleged failure to publish results on EUCTR considered under Clause 9.1 and potentially Clause 1.11; no ruling made in relation to Clause 13.1.
Rulings: No breach of Clauses 1.11, 9.1 and 2 (trial 2009-011250-17); no breach of the Code (trial 2011-000653-23, out of scope due to no UK involvement).

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AUTH/3070/9/18: Director v Johnson & Johnson (Janssen) — Clinical trial disclosure on EUCTR (no breach)

Key facts

What happened

Outcome

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