AUTH/3118/11/18: Director v Tesaro — Clinical trial results posting on EUCTR (No breach on appeal) | PMCPA Case

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Key facts

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Case number	AUTH/3118/11/18
Parties	Director v Tesaro
Issue	Clinical trial disclosure / posting results on EU Clinical Trials Register (EUCTR)
Trigger	BMJ paper: Goldacre et al (12 September 2018) on EUCTR results reporting compliance
Trial referenced	2006-002164-26
Trial dates	Started 18 January 2007; completed 22 October 2007
Summary report date / EUCTR availability	Dated 23 September 2008; made available on EUCTR 19 October 2018
EC guideline deadline referenced	21 December 2016
Applicable Code year	2016
Clauses considered	1.11, 2, 9.1
Panel outcome	Breach of Clause 9.1; no breach of Clause 1.11; no breach of Clause 2
Appeal outcome	Appeal successful; no breach of Clause 9.1; overall no breach of the Code
Complaint received	21 November 2018
Case completed	18 September 2019

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

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The PMCPA Director opened a complaint (Paragraph 5.1) after a BMJ paper (Goldacre et al, 12 Sept 2018) ranked sponsors’ compliance with posting trial results to the EU Clinical Trials Register (EUCTR) by the final compliance date of 21 December 2016.
The issue for Tesaro related to one due trial on EUCTR (EudraCT 2006-002164-26) with a UK site; results were not shown as posted by the deadline, giving a 0% disclosure rate in the BMJ dataset.
The trial investigated SCH619734 (later known as Varuby/rolapitant) in chronic idiopathic cough; it started 18 January 2007 and completed 22 October 2007, sponsored by Schering Plough Research Institute (US).
Tesaro explained the asset changed hands via merger/divestment/licensing (Schering Plough → Merck & Co merger → divestment to OPKO Health in 2009 → exclusive licence to Tesaro Inc in Dec 2010). Tesaro said it was not the sponsor and not an affiliate of the sponsor.
The trial summary report (dated 23 September 2008) was made available on EUCTR on 19 October 2018, before Tesaro was notified of the complaint; Tesaro Inc posted it following a request from Merck Sharp & Dohme, which no longer had access rights.

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Final outcome (Appeal Board): No breach of the Code.
The Panel initially ruled a breach of Clause 9.1 (late posting vs the EC guideline timeline), but this was appealed.
The Appeal Board accepted it was good practice to follow the EC Guideline timing, but in the exceptional circumstances did not consider the late posting warranted a breach, particularly as results were already publicly disclosed and posted before the complaint was received.
No breach of Clause 1.11, Clause 2, or Clause 9.1 (final).

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